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Coronavirus: A timeline of how the deadly COVID-19 outbreak is evolving

9:53 am

Coronavirus company news summary – Eurobio Scientific expands its range of Covid-19 tests – Quest Diagnostics granted CDC contract to sequence Covid-19 gene variants

Eurobio Scientific has announced the expansion of its entire range of Covid-19 tests. This included its new proprietary antigenic test called the EBS 10-20 Ag Test, which can detect the SARS-Cov-2 antigen with the help of a nasopharyngeal ergonomic swab. The test also helps yield results within just 10 minutes.

Quest Diagnostics has announced an agreement with the Centres for Disease Control and Prevention (CDC) to offer genomic sequencing to identify new SARS-CoV-2 mutations, thereby providing insights into the prevalence and transmission patterns of the virus in the US. The goal of the collaboration is to conduct a large-scale longitudinal genomic survey of the SARS-CoV-2 virus using random collected samples.

Neuberg Diagnostics has received approval from the Indian Council of Medical Research (ICMR) to conduct Covid-19 tests across Andhra Pradesh, New Delhi, Kerala, and Tamil Nadu. The laboratories will be established in Noida, Visakhapatnam, Salem and Kozhikode, with capacities to process approximately 7,000 reverse transcription polymerase chain reaction test samples each day.

9:26 am

Coronavirus company news summary – Rapid blood test identifies Covid-19 patients at high risk of severe disease – Israeli company develops ‘breathalyser’ Covid-19 test with 98% accuracy

Scientists at the Washington University School of Medicine in St Louis have revealed a rapid blood test that can predict severe complications and even deaths in hospitalised Covid-19 patients. The study involved approximately 100 infected patients that were newly admitted to the hospital. The test measures levels of mitochondrial DNA, a unique type of DNA molecule that normally resides inside the energy factories of cells. Mitochondrial DNA spilling out of cells and into the bloodstream is a sign that a particular type of violent cell death is taking place in the body.

Scentech Medical, an Israeli-based breath test diagnostics company, has developed a new and more accurate test that can screen for Covid-19 in just a few minutes and with 98% accuracy, reports Times of Israel. The test operates like a breathalyser test used by police. It is not yet authorised for use or approved by the Food and Drug Administration (FDA).

Eurofins, an international group of laboratories providing testing and support services, has announced a number of new initiatives aimed at increasing testing capacity of the SARS-Cov-2 virus. As part of this, it will launch NovaType, a SARS-CoV-2 RT-PCR assay, for identifying B.1.1.7 and B.1.351 variants. NovaType is already available in Germany and will be made available in many European countries for trial.

Global WholeHealth Partners Corp has encouraged the increase in research and development into Covid-19 SARS 2 testing. FDA authorised Covid-19 point of care serology tests can get results within minutes. Global WholeHealth Partners expects to distribute these tests to urgent care centres, hospitals, and others to help curb the spread of the SARS-CoV-2 virus

9:45 am

Coronavirus company news summary – Cepheid receives Health Canada license for SARS-CoV-2, Flu A, Flu B and RSV combination test – SML Genetree receives FDA EUA for Ezplex SARS-CoV-2 G real-time PCR Kit

Chembio Diagnostics has received CE certification for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems. The company has also entered into a distribution agreement with Luas Diagnostics, to start selling the products immediately in the UK and Ireland.

Cepheid, a molecular diagnostics company, has been granted a Health Canada license for its Xpress SARS-CoV-2/Flu/RSV, a rapid molecular combination diagnostic test that can detect SARS-CoV-2, Flu A, Flu B, and RSV infections from a single sample. The test can deliver results in approximately 36 minutes and is now made available in Canada and can also be used in laboratories and at point of care facilities.

SML Genetree announced that it has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for its Ezplex SARS-CoV-2 G Kit, a real-time molecular diagnostic test that helps in detecting RNA from the SARS-CoV-2 virus from nasal and oral swabs, sputum specimens, as well as for use in pooled samples.

9:59 am

Coronavirus company news summary – Biomerica’s 15-minute Covid-19 Rapid Antigen Test receives CE Mark – Abbott fulfils US government purchase of 150 million BinaxNOW Covid-19 Rapid Tests

The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to ADVAITE’s RapCov Rapid COVID-19 Test. The biotech company is among the handful of manufacturers to be granted EUA for a point-of-care serology test.

Biomerica, a global biomedical company that manufactures diagnostic products, has received CE mark certification for its new Covid-19 Rapid Antigen Test that helps in detecting the SARS-Cov-2 virus. The company has already received its first orders and plans to ship the tests in the weeks ahead and will now market its product across the Europe and outside the US.

Abbott has fulfilled the US government’s purchase order of 150 million BinaxNOW Covid-19 Ag tests. These tests were distributed across the Department of Health and Human Services (HHS) to states, territories, nursing homes, historically black colleges and universities (HBCUs), assisted living facilities, home health and hospice agencies, and the Indian Health Service. The company will supply 30 million additional tests through March under a new government order.

9:48 am

Coronavirus company news summary – Quanterix receives FDA emergency use authorisation for SARS-CoV-2 N Protein Antigen Test – SourceBio signs deal to process high street Covid tests

T2 Biosystems, an in vitro diagnostics company,  has announced that its T2SARS-CoV-2™ Panel is capable of identifying multiple variants of the SARS-CoV-2 virus. This includes the new virus strain that recently showed up in the UK, US, and South Africa.

Victory Square Health has announced that the Brazilian Health Regulatory Agency (ANVISA) has permitted the company to begin sales, marketing, and distribution of its Safetest 15 Minute Covid-19™ Rapid Test assay in Brazil, which helps in detecting IgG and IgM antibodies against the SARS-CoV-2 virus.

Quanterix has announced that the US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to its Simoa® SARS-CoV-2 N Protein Antigen Test to be run on the Simoa HD-X Analyzer®, an automated high-throughput immunoassay instrument.

SourceBio International, a clinical laboratory company, has struck a deal with an unnamed high street retail and pharmacy group to offer laboratory-based testing services to support increased testing across UK stores. Under the terms of the initial year’s agreement, SourceBio will provide Covid-19 PCR Testing services from its laboratory facility at Nottingham.

9:14 am

Coronavirus company news summary – Everlywell and Gingko Bioworks sign agreement to distribute rapid antigen tests – UK orders first tests for asymptomatic Covid-19 testing

Everlywell, a digital health company, and Ginkgo Bioworks, a life sciences company, have entered into an agreement to distribute Access Bio’s CareStart™ Covid-19 antigen test, which has been approved by the US Food and Drug Administration (FDA), to government offices, workplaces, schools, clinics and health plans. The CareStart™ Covid-19 antigen test includes a disposable rapid antigen testing lateral flow device that can detect the SARS-CoV-2 infection just 15 minutes.

The FDA is monitoring the potential impact of Covid-19 viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorised SARS-CoV-2 molecular tests. It believes the risk that Covid-19 mutations will impact overall testing accuracy is low. The agency has reminded clinical laboratory staff and health care providers about the risk of false negative results with all laboratory tests, including molecular tests. Laboratories should expect some false results to occur even when very accurate tests are used.

Matt Hancock, the Health and Social Care Secretary of the UK, has announced that the government has ordered for two million of the first British-manufactured rapid lateral flow antigen tests for use in asymptomatic testing, which will be validated by Public Health England. SureScreen Diagnostics, a bespoke diagnostic solutions manufacturer, will provide the two million lateral flow tests, which yields results in less than 30 minutes.

9:54 am

Coronavirus company news summary – ForaCare Suisse releases rapid Covid-19 antigen test – Spectrum Solutions partners with Steribottle for saliva-based Covid-19 testing in the UK

ForaCare Suisse has developed the FORA COVID-19 Antigen Rapid Test, which it says provides accurate and easy-to-interpret test results for detecting an acute infection of the virus within 15 minutes. The test does not require laboratory testing and can be administered by trained experts. Clinical results indicate that the test has a 95.8% sensitivity and a 98.6% specificity, however tests have only been carried out on a small number of samples thus far.

Spectrum Solutions has partnered with Steribottle, a disposable sterile baby bottles manufacturer and distributor, to offer its SDNA-1000 saliva collection device to comply with Covid-19 testing directives in the UK. The Spectrum Solutions SDNA-1000 Saliva Collection Device was the first saliva-based solution to receive the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for COVID-19 testing.

Twist Bioscience will supply the US Centers for Disease Control and Prevention (CDC) with a customised version of the Twist SARS-CoV-2 Synthetic RNA Controls for use in the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay tests. The tests are designed to detect influenza A, B and SARS-CoV-2 from one sample.

Clear Labs has broadened the scope of its partnership with Integrated DNA Technologies (IDT), a supplier of custom nucleic acids, to automate and improve the accuracy of Covid-19 testing. Clear Labs’ sequencing platform for diagnosing the SARS-CoV-2 virus employs IDT primers as part of its solution.

9:54 am

Coronavirus company news summary – JOYSBIO’s Covid-19 antigen test kit detects new strain – Europe approves Seegene’s saliva-based Covid-19 test kit

JOYSBIO Biotechnology has developed the SARS-CoV-2 Antigen Rapid Test Kit, which is capable of detecting the new Covid-19 strain found in the UK and US. Referred to as SARS-CoV-2 VUI 202012/01, Variant of Concern 202012/01, VOC-202012/01, or lineage B.1.1.7, was identified first in England during the autumn of 2020, and later in France and the US as well.

A Prince of Songkhla University team in Thailand have developed a new Covid-19 test kit that shows 99% accuracy in detecting antibodies in the blood within 15 minutes. The kit has been approved by Thailand’s Food and Drug Administration (FDA) and will be produced at a rapid pace of 100,000 kits per day.

Sensus Healthcare has announced that Holy Name Medical Centre in Teaneck, New Jersey has acquired a Sensus low-dose radiation therapy system for treating pneumonia in Covid-19 patients. The SRT-100+™ and SRT-100 Vision™ systems are portable and can allow immediate treatment in an intensive care unit rather than having to transport patients to cancer treatment centres that increase the chances of exposure to the SARS-CoV-2 virus.

Seegene has been granted CE-IVD permits in Europe for its two in-vitro diagnostic saliva-based test kits that help in detecting the Covid-19 disease. The two test kits, Allplex SARS-CoV-2 Assay and Allplex SARS-CoV-2/FluA/FluB/RSV Assay, can detect four target genes for Covid-19 and simultaneously identify the new coronavirus and flu respectively.

10:01 am

Coronavirus company news summary – New Covid-19 RNA test from the UK gives accurate results within minutes – Shuwen obtains CE-IVD mark for Covid-19 test kit

Researchers from the UK University of Birmingham have developed a Covid-19 RNA test that can deliver accurate results within five minutes. The test uses an amplification technique called Exponential Amplification Reaction (EXPAR) which uses very short, single strands of DNA for the replication process, which can be completed in a matter of minutes.The entire test can be run on standard laboratory equipment at lower temperatures compared to PCR tests, which require higher temperatures to separate out strands of DNA as part of the amplification process.

Nirmidas Biotech has announced its second Emergency Use Authorization (EUA) approval from the US Food and Drug Administration (FDA) for its Covid-19 rapid antibody IgG/IgM test. The test is now available at point-of-care settings. The MidaSpot™ COVID-19 Antibody Combo Detection Kit uses a fingerstick serology test to detect antibodies against the receptor‐binding domain (RBD) antigen on the surface of the SARS-CoV-2 virus.

Trinity Biotech has achieved a CE mark for its Captia™ SARS-CoV-2 IgG ELISA antibody test. Trinity has launched the test across all European Union (EU) countries as well as other countries that approve the CE mark.

Shuwen Biotech has been granted the CE-IVD mark for its SARS-COV-2 RT-PCR Kit. The Chinese government agency has also granted the company clearance for exporting the kit. The kit is currently available in Europe for distribution and in other regions that recognise the CE certification.

10:02 am

Coronavirus company news summary – Health Canada authorises CytoSorb for hospitalised Covid-19 patients – NextGen announces rapid breath test for Covid-19 detection to evaluate efficacy of vaccines

Enzo Biochem has received an expansion of its Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) to conduct tests on pooled samples that contain up to five individual swab specimens. The tests will be conducted on the AMPIPROBE® SARS-Cov-2 Test System using three different platforms including Enzo’s GENFLEX™ automated high-throughput platform.

CytoSorbents Corporation has received medical device authorisation from Health Canada to import, sell, and use its CytoSorb blood purification technology to treat hospitalised Covid-19 patients. The company is expected to collaborate with ebbtides medical, a specialty distributor of medical products, to accelerate the availability of the therapy.

NextGen Biomed, has received approval from the Shamir Medical Centre (Asaf Harofe) Review Board for a clinical trial of its rapid breath test to detect the SARS-CoV-2 virus, as well as evaluate the efficacy of vaccines. The company will monitor the IgM and IgG antibody among those getting vaccinated for Covid-19, to assess the effectiveness of different treatments.

Innova Medical Group (IMG) has acquired California-based MPS Medical, to expand its Covid-19 rapid test kit manufacturing capacity in the US. MPS Medical is an FDA registered medical device manufacturer known for high-quality medical devices. As per the new ownership, MPS Medical will aggressively ramp up capacity for multi-millions of test kits per day in California, anticipating greater demand for domestic and international customers.

9:52 am

Coronavirus company news summary – Scientists in Turkey develop ten second Covid-19 test with 99% accuracy – Emergency departments in North Wales join instant testing study for Covid-19

Researchers at the Bilkent University National Nanotechnology Research Center in Turkey have developed a ten second Covid-19 test named Diagnovir that can deliver results with 99% accuracy. The test uses nanotechnology to detect Covid-19 pathogens using fluorescent signal. A positive result is delivered within five to ten seconds, while negative result can take up to 20 seconds.

The Indian Council of Medical Research-Regional Medical Research Centre (ICMR-RMRC) has conducted a study to evaluate the use of saliva as a Covid-19 diagnostic sample, instead of nasal and throat swab samples. The study showed that the results using saliva samples were comparable with those using nasal samples. Use of saliva makes sample collection easier and also reduces the chances of infection among healthcare workers. The study compared 74 samples of Covid-19 patients using nasal swabs and saliva specimens.

Emergency departments in North Wales are joining a UK study that will assess the effectiveness of Covid-19 tests that can give instant results. The Facilitating Accelerated Clinical Evaluation of Novel Diagnostic Tests for Covid-19 (FALCON) study will assess the accuracy of new and faster tests, as current tests take up to 48 hours to deliver results. The study is being conducted by researchers across the United Kingdom with Manchester University NHS Foundation Trust acting as the sponsor for the study.

8:16 am

WHO says new variant of Covid-19 virus in UK not out of control

The World Health Organisation (WHO) said that the new variant of Covid-19 virus discovered in the UK with a higher transmission rate is ‘not out of control’ and could be contained with the help of existing measures.

Earlier, British Health Secretary Matt Hancock had claimed that the variant was out of control, while officials said that it was 70% more transmissible than the main strain, AFP reported.

The new agency quoted WHO emergencies chief Michael Ryan as saying in a press conference: “We have had a much higher (contamination rate) at different points in this pandemic and we’ve got it under control.
“So this situation is not in that sense out of control. But it cannot be left to its own devices.”

Earlier this week, the UK found that the new variant identified through Public Health England’s genomic surveillance could spread faster.

WHO Director-General Dr Tedros Adhanom Ghebreyesus said in a media briefing: “In the past few days, there have been reports of new variants of the Covid-19 virus in South Africa and the United Kingdom. Viruses mutate over time; that’s natural and expected.”

“WHO is working with scientists to understand how these genetic changes affect how the virus behaves.”

9:47 am

Coronavirus company news summary – Biocogniv and Research Partners study an AI tool to assist clinical labs in Covid-19 testing – CSIR-CCMB and Apollo hospitals collaborate on rapid and safe Covid-19 testing kits

Applied BioCode has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of its BioCode® SARS CoV-2 molecular diagnostic assay along with pooled patient samples. The EUA permits BioCode to carry out pooled testing of up to five individual patient samples suspected to be infected with the SARS-CoV-2 virus.

Advanced MedTech Holdings (AMTH), a Singapore-based medical technology firm, announced that the RESOLUTE 2.0 test kit it co-developed with A*STAR and DSO National Laboratories has been authorised by the Health Sciences Authority (HSA) for deep-throat saliva (DTS) SARS-CoV-2 testing. AMTH holds the manufacturing and distribution rights for the test kits, which is easy-to-use and reduces the risk of virus spread.

Researchers from the University of Vermont and Cedars-Sinai have collaborated to study the performance of a Biocogniv’s COVID™ software. The team found that the artificial intelligence (AI) tool had high accuracy in predicting the probability of Covid-19 infection using routine blood tests, which can help hospitals reduce the number of patients referred for scarce PCR testing.

The Indian Council for Scientific and Industrial Research-Centre for Cellular and Molecular Biology (CSIR-CSMB) and Apollo Hospitals have collaborated to jointly manufacture and commercialise a dry swab test, Direct Amplification rapid RT-PCR (DArRT-PCR) for Covid-19 detection. The DARrT-PCR is cost effective and will be made available across India through the Apollo Hospitals network.

9:52 am

Coronavirus company news summary – LabCorp receives FDA authorisation to sell at-home Covid-19 collection kits through retail – ams and Senova inaugurate production line for Covid-19 antibody digital rapid tests

LabCorp has been granted Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the Pixel by LabCorp™ Covid-19 Test Home Collection Kit to be made commercially available without requiring prescription. The approval will allow LabCorp to distribute the at-home kits through retail channels.

Roche and Moderna have announced a partnership to utilise the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will to measure the SARS-CoV-2 antibodies of trial participants to establish a correlation between vaccine-induced protection and anti-receptor binding domain (RBD) antibodies. Roche was recently granted EUA for the Elecsys® antibody test.

Ellume, a digital diagnostics company, has announced that its rapid, at-home Covid-19 antigen test demonstrated 96% accuracy in a US clinical study conducted across five states. The Ellume Covid-19 home test is considered to be easy to use and safe for detecting the SARS-CoV-2 nucleocapsid antigen among those aged two years and above. The rapid self-test delivers results in 15 minutes or less.

ams, a supplier of sensor solutions, and Senova, an in-vitro diagnostic medical devices manufacturer, have announced the opening of a production line for lateral flow tests that will help detect antibodies from the SARS-CoV-2 virus. The cost-effective platform was developed in less than nine months and will process the data in a secure medical cloud.

10:06 am

Coronavirus company news summary – Bluejay and Toray collaborate to develop point-of-care test for Covid-19 patient triage – ixlayer’s technology selected for Covid-19 research collaboration

Meridian Bioscience, a diagnostic testing solutions provider, has applied for Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 molecular diagnostic test on the Revogene® platform. The test can detect the SARS-CoV-2 virus among individuals in 47 minutes and can be integrated in any laboratory or health system.

Bluejay Diagnostics and Toray Industries have entered into a collaborative agreement to develop a minimally invasive, point-of-care test to assess the progress of Covid-19 in high-risk patients. The Symphony™ IL-6 combines microfluidics and nanotechnology to create point-of-care tests in liquid biopsies.

ixlayer, a healthtech solutions provider, announced that its technology has been selected for a Community Alliance to Test Coronavirus at Home (CATCH) Study initiated by the Chan Zuckerberg Biohub and Stanford University. The study intends to conduct large-scale research on the testing and tracking of Covid-19 in the greater San Francisco Bay Area.

CorVent Medical has received EUA from the FDA for its RESPOND-19™ ventilator, which is able to be used by multiple patients. This new category of ventilators is designed for expanding critical care ventilation capacity to hospitals struggling with increasing number of Covid-19 patients suffering from acute respiratory distress syndrome (ARDS). The respiratory system is cost effective, reusable for multiple patients, and is commercially available in the US.

9:42 am

Coronavirus company news summary – Thermo Fisher scientific releases new CE-marked Covid-19, flu A/B, RSV combo kit – Everlywell signs agreement to distribute Cellex’s Covid-19 rapid antigen test

NOWDiagnostics has announced that encouraging test results from its ADEXUSDx® Covid-19 antibody test has helped the company to file for Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA). The antibody test delivered 100% sensitivity and 100% specificity in a Biodefense and Emerging Infections Research Resources Repository (BEI Resources) study.

Thermo Fisher Scientific has received the European CE-mark for its TaqPath Covid-19, flu A/B, RSV combo kit for the diagnosis of the SARS-CoV-2 virus, influenza A/B and respiratory syncytial virus (RSV) A/B infections. Laboratories can now run a single test for detecting all these infectious diseases and monitor the progress and spread of the diseases in just three hours.

Victory Square Technologies has struck two manufacturing, sales and distribution agreements to supply White Label Covid-19 Rapid Antibody and Antigen Tests through the company’s global distribution network, as well as through its ecommerce platforms. The agreements will also allow Victory Square to manufacture and market other White Label diagnostic tests on its soon-to-be launched telehealth platform.

Everlywell, a digital health company, has struck a distribution agreement with Cellex, a diagnostics manufacturer, to distribute Cellex’s Covid-19 rapid antigen test for use by public health agencies and professionals. The point of care rapid antigen test still awaits emergency use authorisation by the FDA.

11:53 am

Coronavirus company news summary – FDA authorises first Covid-19 and flu combination test for use with home-collected samples – CRISPR-based Covid-19 test uses smartphone cameras to spot virus RNA

The US Food and Drug Administration (FDA) has authorised the first diagnostic test for at home sample collection and detection of both Covid-19 and influenza A and B (flu). The Quest Diagnostics RC COVID-19 +Flu RT-PCR Test is now eligible for prescription use along with the Quest’s Self-Collection Kit for COVID-19 +Flu for individuals suffering with respiratory viral infection that may be consistent with Covid-19.

Scientists from the University of California Berkeley and Gladstone Institutes have developed a new CRISPR-based Covid-19 diagnostic test that uses smartphone cameras to detect a positive or negative result in 30 minutes. Unlike other tests, this one allows doctors to monitor the severity of the disease in patients and how contagious they may be depending on the number of virus particles in a sample.

Achiko and Udayana University have collaborated to conduct Covid-19 mass testing in Bali. The partners will study the acceptance and feasibility of mass testing and its effects on the healthcare industry, consumer and business confidence. As per the research agreement, the testing will be conducted across three islands, Nusa Penida, Nusa Lembongan and Nusa Ceningan.

ADVAITE, a biotech company, has received a CE mark clearance for its Covid-19 rapid response IgG antibody test, RapCov™, to help efforts to curb the spread of the virus. The company is collaborating with OBELIS in the Europe, as an authoritative representative, to expand and market the diagnostic testing kits.

9:51 am

Coronavirus company news summary – AXIM develops ELISA-based neutralising antibody diagnostic test for Covid-19 – ixlayer and CIC Health partner to expand Covid testing in US schools and universities

Intrivo Diagnostics announced that it has entered into a national distribution agreement with Concordance Healthcare Solutions and NDC to start the distribution and commercialisation of New Jersey-based Access Bio’s CareStart™ line of coronavirus testing products throughout the US. The move aimed at broadening the reach and access to CareStart portfolio of Covid-19 diagnostic products.

AXIM Biotechnologies has developed and filed a patent for an enzyme-linked immunosorbent assay (ELISA)-based diagnostic test for detecting SARS‐CoV-2 neutralising antibodies. The filing is AXIM’s fourth Covid-19 neutralising antibody-based patent application.

Drawbridge Health and the Medical Research Council Epidemiology Unit at the University of Cambridge have collaborated to investigate the use of the OneDraw™ Blood Collection Device as a method of blood sample collection for assessing the prevalence of a prior Covid-19 infection. The large-scale surveillance study enables non-contact blood collection and safe delivery of samples to clinical testing laboratories.

ixlayer, a technology-based diagnostic solutions provider, has partnered with CIC Health to expand the access of Covid-19 testing to more US schools and universities. CIC Health will use ixlayer’s COVID-19 Clinical Testing Platform to provide testing services including distribution of the tests, coordinating with labs and tracking patients, to school districts and universities across the nation.

9:51 am

Coronavirus company news summary – Oxford Immunotec signs agreement with RIKEN Genesis to market the T-SPOT Covid kit – Selfdiagnostics to submit request for authorisation

Oxford Immunotec, has entered into a distribution agreement with RIKEN Genesis in Japan. As per the agreement, RIKEN will have exclusive distribute Oxford’s T-SPOT Discovery SARS-CoV-2 kit. The kit has been developed to detect and measure SARS-CoV-2 specific T cells, thereby offering more insight into immunity responses to the SARS-CoV-2 virus.

Chembio Diagnostics it has received a $12.7m contract from the Biomedical Advanced Research and Development Authority (BARDA), for developing and procuring Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system. The test is designed to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B and SARS-CoV-2 antigens from a single patient respiratory specimen. It is hoped to assist in the containment of Covid-19 cases during flu season.

TNG Dx has partnered with the US Department of Health and Human Services and eTrueNorth to create a rapid RNA extraction protocol as part of a community-based surveillance initiative. The new methodology will help clinical laboratories to deliver Covid-19 analysis and results faster, thereby affordable increasing the number of tests they can process.

European-based Selfdiagnostics is planning on submitting a request for authorisation on for its at-home molecular diagnostic test to help in the detection of the SARS-CoV-2 virus. Selfdiagnostics rapid PCR is the first multifunctional test that is able to detect Covid-19 and influenza from one nasal swab.

10:02 am

Coronavirus company news summary – Roche receives FDA EUA for new semi-quantitative test – ams wins Federal funding in Austria to bolster pandemic control

Roche has announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has recieved emergency use authorisation (EUA) from the US Food and Drug Administration (FDA). The semi-quantitative blood test will be used to measure antibody levels among individuals who have been exposed to the SARS-CoV-2 virus. This could help to guide the allocation of plasma donations from recovered Covid-19 patients to those who are seriously ill with the virus, by narrowing down those with the highest antibody levels.

GENETWORx Labs have launched a diagnostic Flu A-B/COVID-19/RSV combination test to help in the early detection of all the three separate viruses from a single sample. The US has reported exploding coronavirus cases across the country, with the government looking to fast-track testing in the upcoming days in winter.

The Austrian Federal Ministries for Transport, Innovation, Technology, and Digital and Economic Affairs has awarded funding to ams, a high-performance sensor solutions supplier, to fast-track the development of a cloud-based, highly-sensitive, Lateral Flow Test (LFT) that will help in the detection of the SARS-CoV-2 virus. Based on the pre-existing ams spectral sensor AS7341L, ams says the test will offer results in 15 minutes.

Multi Radiance Medical is looking to apply for FDA EUA, after the completion of its super pulsed laser therapy technology intended to improve the respiratory condition of critical Covid-19 patients. The trial data found that MRM’s laser therapy reduced invasive intubation time by 18% and mechanical ventilation time by 23%.

9:52 am

Coronavirus company news summary – Cell ID unveils portable genetic test for Covid-19 – LGC submits EUA for high-throughput PCR testing system

Cell ID, a Singapore-based med-tech company, has announced that its portable genetic Quiz PCR Biochip test can be conducted via saliva specimen or nasal swab to detect the SARS-CoV-2 virus within minutes. The company also claims that it is commercially ready and can be used via an app on a laptop to conduct tests anytime, anywhere.

Empower has entered into a North American Re-Seller and Distribution Agreement with API Pharma for its rapid antigen test and rapid antibody test, for which it has submitted a request for Emergency Use Authorisation (EUA) to the US food and Drug Administration (FDA).

LGC has submitted a request for EUA to the FDA for its high-throughput RT-PCR testing system to detect the SARS-CoV-2 virus. LGC’s high-throughput RT-PCR workflow can deliver approximately 35,000 tests per day with just one scaling system.

The Wyss Institute for Biologically Inspired Engineering at Harvard University has licensed its eRapid technology to The iQ Group Global for Covid-19 diagnostic applications. The Australian consortium intends to integrate the technology with its transistor technology for specific and sensitive SARS-CoV-2 testing to address gaps in the development of Covid-19 diagnostics.

9:23 am

Coronavirus company news summary – Immunodiagnostic Systems launces two rapid Covid-19 tests – UBC-Providence scientists join WestJet and YVR for Covid-19 testing study

Immunodiagnostic Systems has announced the availability of two SARS-CoV-2 antigen rapid test kits in the UK, EU and other countries that accept the CE mark. The tests can be performed by all healthcare professionals, using direct nasopharyngeal swab samples that provide results within 15 minutes.

The Indian Council of Scientific & Industrial Research – Centre for Cellular and Molecular Biology (CSIR-CCMB) has received Indian Council of Medical Research (ICMR) approval to commercially use the dry swab RNA-extraction free testing method for detecting the SARS-CoV-2 virus. The move allows health authorities to scale testing and access at lower costs compared to other conventional RT-PCR tests, with a quick turnaround time.

The University of British Columbia (UBC) and Providence Health Care have collaborated to launch the WestJet-YVR Covid-19 Testing Study. A first-of-its-kind in Canada, the study will investigate Covid-19 rapid testing to create more effective ways to test departing passengers at the Vancouver International Airport (YVR).

Veritas Intercontinental has launched a new service that analyses individual cients’ response to Covid-19 through whole genome or whole exome sequencing. The objective of the saliva-based sample analysis is to personalise treatment for individuals and avoid complications. People can avail the service through Veritas or Veritas partner networks, and those who have their genome sequenced through the myGenome by Veritas can receive the Covid-19 study without additional sample submission.

9:44 am

Coronavirus company news summary – Biolidics inks deal to distribute Chinese biotech’s Covid-19 test kits – Alberta launches rapid testing pilot

Salient Bio, a UK diagnostic firm, has launched the fastest robotics-driven Covid-19 mass testing platform, reports Pharma Phorum. The company claims that the platform can provide results with a 99% accuracy. There are different mass testing approaches, one being the breath test which has prompted the trial of the Microtox device. The UK is also conducting a mass trial programme at Liverpool, which has a surge in virus infections.

BASE10 Genetics and DNA Link have announced a collaboration to evaluate the use and efficacy of DNA Link’s AccuFind COVID-19 IgG antibody test in a point-of-care healthcare setting. Although Covid-19 cases and mortality rates have witnessed a recent surge in the US, many individuals have also recovered from the infection.

Biolidics Limited has entered into a deal with the Chinese biotech company, JOYSBIO, to develop and/or distribute the latter’s certified SARS-CoV-2 Antigen Rapid Test Kit. Under the terms of the agreement, Biolidics will distribute the kits worldwide for a period of one year from the date of the agreement.

Alberta Health Minister Tyler Shandro, the health minister has announced that the province is launching rapid Covid-19 tests in December to fast-track testing of all individuals showing Covid-19 symptoms and to track down everyone infected within the territory. Shandro stated that almost 100,000 PanBio and Abbott IDNow rapid-test kits were available for distribution and will be sent as a test pilot across the province to curb the spread of the disease.

11:05 am

Iceni test determines Covid-19 infection rate

Iceni Diagnostics has developed a rapid Covid-19 test that it claims can determine whether or not a patient is actually infectious.

The lateral flow assay is designed to react to live, intact virus, unlike the most other tests, which will react to any form of viral genetic material or protein. The test works by detecting the viral cells’ interaction with sugars that surround human cells.

Manchester Institute of Biotechnology professor Dr Rob Field said: “We believe this technology could change the way we tackle Covid. Where we can quickly tell who is infectious, we can make much better decisions about whether we go to work, school or university and more efficiently manage quarantine periods following international travel.”

Iceni is set to trial its technology in care homes through Cambridge Clinical Laboratories over the coming weeks.

9:17 am

Coronavirus company news summary – Co-Diagnostics CoSara receives clearance for Saragene in India – Abionic launches first Covid-19 severity test

Co-Diagnostics subsidiary CoSara Diagnostics has received Central Drugs Standard Control Organization (CDSCO) clearance in India to both manufacture and sell its Saragene™ Covid-19 2-gene multiplex RT-PCR test as an in vitro diagnostic (IVD) for the detection of the SARS-CoV-2 virus.

Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, has received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its COVID-SeroKlir, a semi-quantitative SARS-CoV-2 IgG antibody test kit. The antibody test kit is regarded as different from other kits in determining the presence of the exact level of IgG antibodies. It is being manufactured at a capacity of up to 10 million tests per month.

Swiss medtech company Abionic has launched the cSOFA score, a Covid-19 severity test tool that measures medical criteria and clinical deterioration among Covid-19 patients. This enables healthcare professionals to decide the course of treatment for different patients and whether they need to be assigned to intensive care units, general wards, or discharged, thereby freeing up the capacities at hospitals.

CaptiGen has announced the development of CaptiSwab, knitted sterile swabs that can help collect clinical samples for the microbial detection of the SARS-CoV-2 virus through RT-PCR, and next-generation sequencing (NGS). CaptiSwab is designed to optimise accuracy and extraction from the device.

9:10 am

Coronavirus company news summary – RapidRona self-collection kit awarded EUA – Genomica launches new PCR test to differentiate Covid-19 from other respiratory viruses

RapidRona has recieved Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 sample self-collection kit. The company looks to enhance rapid access to in vitro diagnostic testing for Covid-19 as the disease stretches into the flu season.

Cepheid has received CE-IVD marking for its Xpress SARS-CoV-2/Flu/RSV, a rapid molecular test that helps detect Covid-19, Flu A, Flu B, and RSV virus from one sample. The test, which delivers results in 36 minutes, received emergency use authorisation from the FDA in September 2020, and is now available in European markets.

The FDA notified the entry of two ender Covid-19 tests, ender LAB and ender MASS, into the US market. ender diagnostics North America, the US subsidiary of ender diagnostics, is ready to deliver the 30-minute rapid, reliable, and cost-effective Swiss-developed Covid-19 testing kits to diagnostic laboratories to increase testing capacities.

Genomica, a Spanish molecular diagnostic company, has launched a new PCR test to detect and differentiate between Covid-19 and other respiratory viruses such as Influenza A and B and respiratory syncytial virus (RSV). The new test has already obtained CE marking, is available across diagnostic laboratories and hospitals.

9:28 am

Coronavirus company news summary – ARUP Laboratories announces the availability of a combined test for Covid-19, Influenza, and RSV – GE Healthcare announces first x-ray AI to help assess endotracheal tube placement for Covid-19 patients

ARUP Laboratories, a University of Utah non-profit enterprise, has announced the availability of a combined test for the detection and differentiation of the SARS-CoV-2 virus, influenza and/or respiratory syncytial virus (RSV) among those suffering with respiratory conditions consistent with Covid-19. It will be avaliable to clients in the US.

LifeLabs, a digital health systems provider,  has announced the launch of its Covid-19 antibody test, which helps in identifying prior exposure to the SARS-CoV-2 infection. Approved by Health Canada, the serology test does not diagnose acute Covid-19 infection but helps in identifying a prior infection, even in asymptomatic individuals.

Zymo Research announced that its quick-DNA/RNA Viral MagBead Kit had received the CE IVD mark for the distribution of the kit in the European Union (EU). The kit will be used for the purification of viral DNA/RNA, such as the SARS-CoV-2 virus, as well as other pathogenic sample types. The kit forms part of the several US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) SARS-CoV-2 test workflows developed by companies.

GE Healthcare has developed an artificial intelligence (AI) algorithm to help clinicians weigh Endotracheal Tube (ETT) placements, an important procedure while critically ill Covid-19 patients are placed on ventilation. One of the five AI solutions included in GE Healthcare’s Critical Care Suite 2.02 helps radiologists in automating processes and prioritising cases, thereby cutting down average review time for up to eight hours.

9:35 am

Coronavirus company news summary – COVAS tool helps predict Covid-19 outcomes – Dubai introduces new saliva test to detect Covid-19 in kids

Ortho Clinical Diagnostics has announced that its CE-marked VITROS® SARS-CoV-2 antigen test can now detect the SARS-CoV-2 virus in asymptomatic individuals as well. The low-cost antigen test can perform 130 tests in one hour, making it a viable testing method for high-throughput testing and monitoring across large communities and populations.

A study conducted by Kaiser Permanente researchers found that a new tool developed by the care consortium helps in accurately predicting patient outcomes individuals infected with Covid-19. The COVAS tool investigates comorbidities, vital signs, obesity, age and sex, and has been fused into the electronic health record system in Southern California to support and guide emergency and critical care centres.

Siemens Healthineers has been awarded a $12m contract by the US Department of Health and Human Services (HHS) and the US Department of Defence (DoD) to support the domestic production of two diagnostic tests for Covid-19. The funding is an addition to the $13m awarded by HHS earlier, to fast-track the company’s development of the diagnostic tests.

Dubai Health Authority (DHA) officials have announced a new saliva test that has been initiated to detect the SAR-CoV-2 virus among children aged between three and 16 years across all DHA-run Covid-19 screening centres in Dubai. The new test was introduced as children found it difficult to take the nasal swab test, thereby encouraging greater screening of kids for the infection, reports the Khaleej Times.

10:10 am

Coronavirus company news summary – PathoFinder obtains CE Mark for two multiplex SARS-CoV-2 MDx tests – Imanis Life Sciences announces improvements and increased capacity

The Apollo Hospitals Group and Tata Medical and Diagnostics (TataMD) have announced the launch of the TataMD CHECK diagnostic test, reports the Times of India. The test is designed to get quicker test results for Covid-19 in India. It is based on the DNA genome editing tool CRISPR Cas-9, which helps in the quicker delivery of results due to its agile AI-based automated detection procedure.

Cue Health has announced that the US Department of Health and Human Services (HHS) will start deploying its molecular, point-of-care Covid-19 tests across five states: Alaska, Louisiana, Florida, New Jersey and Texas. The tests will be utilised to detect positive and negative cases at nursing homes, assisted living facilities, long-term care, veterans’ homes, and will also be deployed at the Department of Defence.

PathoFinder, a Dutch molecular diagnostics developer, has obtained CE IVD marking for two of its multiplex PCR tests for fighting the SARS-CoV-2 virus and other respiratory pathogens. The firm specifically obtained the CE certification for the RespiFinder 2Smart kit for SARS-CoV-2 and MERS-CoV testing, as well as for the RAQ Flu/Covid-19 PCR kit.

Imanis Life Sciences, a laboratory assays and research services provider, announced that it had completed the validation of its improved IMMUNO-COV assay, in detecting and quantifying SARS-CoV-2 neutralising antibodies. The validation adds plasma as a sample type and improves sensitivity and stability along with high accuracy.

9:15 am

Coronavirus company news summary – Cipla launches Covi-G for Covid-19 rapid antibody detection – JOYSBIO releases rapid Covid-19 antigen test

Cipla has entered into a licensing agreement with Multi G for the distribution of Multi G’s Covi-G rapid antibody test kit across Europe and most emerging markets. Covi-G was among the earliest antibody kits to declare CE compliance and has been commercialised in over countries already. With sensitivity and specificity exceeding 92%, it tests for both IgM and IgG antibodies using a single-prick blood test. It gives results within 10 minutes.

SummerBio, a diagnostic company, has partnered with the University of California Los Angeles (UCLA) and the Los Angeles Unified School District (Los Angeles Unified) to launch high-volume testing for the Covid-19 virus. The SummerBio SARS-CoV-2 Test is a nasal swab test conducted by health professionals and produce results within 24 hours.

JOYSBIO Biotechnology has introduced a new rapid Covid-19 antigen test kitwith a nasal swab that can be inserted approximately 2.5 cm into the nostril. This is less invasive than a conventional nasopharyngeal swab, but simple to use like a saliva test. The SARS-COV-2 Antigen Rapid Test Kit is produces results in 15 minutes and is available at all medical stores for home testing and as per local legislation.

Eurofins Viracor, an infectious disease testing laboratory, has announced the launch of combined SARS-CoV-2 Plus Flu A/B and RSV tests. The tests helps in the early detection of multiple pathogens to enable further treatment decisions.

9:28 am

Coronavirus company news summary – FDA authorises first Covid-19 test for self-testing at home – PharmaJet and Diomics partner on immune response monitoring

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for the first Covid-19 diagnostic test to conduct self-testing at home. The Lucira COVID-19 All-In-One Test Kit is a molecular single use test offers rapid results in the detection of the SARS-CoV-2 virus.

Iran’s first vice president Es’haq Jahangiri has hosted the launch of the country’s first rapid Covid-19 antibody test, reports the Tehran Times. Iran is the fifth country to have developed rapid testing technology, following the US, UK, South Korea and China. The test, which can detect the SARS-CoV-2 virus in just 15 to 20 minutes, has been used on approximately 500 patients under the supervision of the Pasteur Institute of Iran.

Trinity Biotech, a developer of diagnostic test kits, has started selling its Covid-19 antibody test in the US, reports the Irish Times. The company is expecting to obtain the CE Mark that allows the product to be sold in the European Union (EU) shortly. The company’s IgG ELISA antibody test still awaits FDA approval, while having sought approval for emergency use authorisation in the country.

PharmaJet has announced that its Tropis Needle-free Injection System will be used by Diomics, a San Diego-based biotech company, to deliver a biopolymer to detect the formation of an immune response to a SARS-CoV-2 protein. The Department of Defense has also awarded the company over $2m to fast-track testing and clinical trials with its Diocheck system, to begin in December 2020.

9:22 am

Coronavirus company news summary – Dana-Farber and Quest Diagnostics collab to identify risk of multiple myeloma after Covid recovery – Balanced Biotech and CSU sign licensing agreement for electronic point-of-care antigen test

Tempus and the Yale School of Public Health have collaborated to fast-track the development of Covid-19 diagnostic tests in the US. The research partnership will leverage the SalivaDirect diagnostic test developed by the Yale researchers to will establish its suitability for at-home sample collection and combined Covid-19 and infleunza testing.

Cape Biologix Technologies, a subsidiary of Cape Bio Pharms, Inno-3B and PlantForm Corporation have entered into a commercial agreement to increase the production of plant-based SARS-COV-2 antigens for Covid-19 antibody blood test. The move is made to scale the production of low-cost, plant-based proteins for Covid-19 monitoring and surveillance.

Dana-Farber Cancer Institute, a cancer research and treatment centre, and Quest Diagnostics have launched a new study which will provide Covid-19 antibody testing for free to people with a high risk of developing multiple myeloma after recovering from the disease. The Immune Profiling with Antibody-based Covid-19 Testing (IMPACT) study will investigate the impact of Covid-19 on people at a higher risk of developing myeloma, or who have a precursor condition to myeloma.

Balanced Biotech and the Colorado State University Research Foundation have entered into a licensing agreement for the Rapid On-the-Spot COVID Test developed by CSU professors and students. The test, initially designed for self-use nasal swab sample collection, uses a sensing method similar to what is used in handheld glucometers to detect active Covid-19 infection.

9:10 am

Coronavirus company news summary – Saliva-based antibody test highly accurate in initial study – First SARS-CoV-2 antigen test to be available in Mexico

Chembio Diagnostics has received Agência Nacional de Vigilância Sanitária (ANVISA) regulatory approval to commercialise its DPP SARS-CoV-2 antigen test in Brazil. The test is designed to detect SARS-CoV-2 antigens in just 20 minutes.

The Johns Hopkins Bloomberg School of Public Health has developed a new saliva-based test that can accurately detect antibodies against the SARS-CoV-2 virus. The test is conducted with the help of small saliva samples instead of finger prick blood withdrawals, the results of which can be obtained in hours.

Kabla Diagnosticos has announced the launch of a rapid diagnostic test to detect the SARS-CoV-2 virus antigen in Mexico. The Sofia SARS Ag test was the first to obtain US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) in the US and is also the first test to be validated by Mexico’s Institute of Epidemiological Diagnosis and Reference (INDRE).

Relay Medical and Fio, together known as the Fio Rapid Response Group (FRR), have netted over $500,000 CAD in initial contracts for the Fionet mobile testing and tracking platform. The platform enables widespread testing against infectious diseases, including Covid-19. FRR has collaborated with South Korea’s IVD Lab Co, with funding received from the National Research Council Canada (NRC), to market the new rapid diagnostic test platform. It is currently being validated at Toronto’s University Health Network (UHN).

9:46 am

Coronavirus company news summary – LogicInk and Contakt World partner to accelerate development of Covid-19 Biosensor Sticker – DnaNudge launches lab-standard 90-minute Covid-19 Bubble Test

AnPac Bio-Medical Science has completed US Food and Drug Administration (FDA) approved antibody test verification in its California lab this month. The Roche Elecsys Anti Sars-COV-2 test will now enter the commercial stage testing, with the Covid-19 antibody test equipment also installed in its Philadelphia lab.

LumiraDx, a diagnostic company, has announced a $32m global partnership with Africa Union, Africa Medical Supplies Platform (AMSP), Africa Centres for Disease Control and Prevention, Bill and Melinda Gates Foundation, and Clinton Health Access Initiative along with the Mastercard and the Rockefeller Foundations to expand and accelerate testing in Africa. LumiraDx will provide 5,000 portable diagnostic instruments and related Covid-19 antigen tests, while AMSP will supply it equitably across 55 African Union member states

LogicInk and Contakt World Technologies Corp announced a collaboration and signed a Memorandum of Understanding (MOU) to fast-track the development of LogicInk’s non-invasive, biosensor sticker for Covid-19. LogicInk’s new signal will enable self-administration and interpret results for the SARS-CoV-2 infection by simply identifying a colour combination.

DnaNudge, which created the rapid, lab-free CovidNudge test used by the NHS, announced the launch of the 90-minute Covid-19 Bubble Test, offering group testing on one cartridge for bubbles up to 10 people with no coronavirus symptoms. The breakthrough test is now available for online booking and through appointment only from DnaNudge’s London’s Covent Garden. It will also be made available as an at-home, by-post service within weeks in the UK.

9:53 am

Coronavirus company news summary – TataMD launches test for Covid-19 – University of Queensland develops Covid-19 viral proteins

Tata Medical and Diagnostics has launched a new Covid-19 diagnostic test, reports LiveMint. The TataMD CHECK was developed through a collaboration between the Indian Council of Scientific and Industrial Research and the Institute of Genomics and Integrative Biology. The test can provide results within 90 minutes, with Tata’s plant in Chennai reportedly able to produce 1 million test kits a month.

Locally produced proteins in Brisbane are proving to be useful for detecting Covid-19. The University of Queensland’s Protein Expression Facility (PEF) has collaborated with the Public Health Virology team at Forensic and Scientific Services (FSS), to develop SARS-CoV-2 viral proteins. The proteins will be utilised in blood tests to screen antibodies for any prior exposure to Covid-19.

Clinical Reference Laboratory (CRL) has begun selling its CRL Rapid Response™ self-collected saliva test directly to consumers. The at-home saliva test is designed to be easy to use, and can delivers results onto users’ mobile phones through an authentication portal within 24 hours.

Centogene and Fujirebio Europe have collaborated to use LUMIPULSE® G technology for large-scale distribution of Covid-19 antigen testing. The tests will be further deployed at German airports, with Centogene having set up test centres at four of Germany’s largest airports in the last six months. Fujirebio is expected to supply Lumipulse G SARS-CoV-2 Ag assays on automated CLEIA-based LUMIPULSE G1200 instruments.

10:19 am

Coronavirus company news summary – Fluidigm and Healthvana partner to offer faster test results delivery – Quansys Biosciences receives FDA EUA for antibody test

Eurofins Technologies has launched the GSD NovaPrime® SARS-CoV-2 Mplex FLA kit for Sanger sequencing instruments. Many of these instruments have been installed worldwide, meaning this launch could help boost throughput testing capacities. More than 2,000 samples can be processed in a day with the help of this assay, with the test kit providing sensitivity and time to results similar to qRT-PCR testing.

The US Food and Drug Administration (FDA) has authorised the first antibody test for point-of-care settings in the US. The Assure Tech Fastep® COVID-19 IgG/IgM Rapid Test Device will be distributed by Carolina Liquid Chemistries, and will be conducted with fingerstick whole blood samples only at certified point-of-care settings.

Fluidigm Corporation has announced a partnership with Healthvana to provide clinical laboratory customers utilizing the Fluidigm® saliva-based Advanta™ Dx SARS-CoV-2 RT-PCR Assay with the option to deliver test results faster via Healthvana’s mobile platform. Ramin Bastani, the CEO of Healthvana stated that on an average, patients were able to view their results within 30 minutes.

Quansys Biosciences has received FDA EUA for its IgG antibody test. A positive IgG antibody result helps detect patients who have been exposed or infected with the SARS-CoV-2 virus, and show adaptive immune response when patients are recovering from the infection.

3:32 pm

All UK contact-tracing apps now interoperable

Scotland’s federated server, which allows for all Covid-19 contact-tracing apps in the UK, Crown Dependencies and Gibraltar to work with each other, has now enabled interoperability with England and Wales’ NHS COVID-19 app and Gibraltar’s Beat COVID Gibraltar app.

Interoperability was achieved between the apps in Scotland, Northern Ireland and Jersey on 28 October.

App users do not need to do anything for this software to work other than keep their app active when travelling between territories. Citizens are still being urged to do so only for essential reasons.

10:15 am

Coronavirus company news summary – Health Canada approves Precision Biomonitoring’s rapid SARS-CoV-2 testing device – South Korea approves single test for Covid-19 and flu

Ortho Clinical Diagnostics has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new VITROS® SARS-CoV-2 antigen test to help detect the SARS-CoV-2 virus. The company also received CE mark certification, allowing the company to market the test across European Union (EU).

Stanford University engineers have created an automated device, which can help detect Covid-19 by leveraging “lab on a chip” technology. Performed on a device about half the size of a credit card, the test is yields results in only thirty minutes. It is cheap, and not reliant on antibodies like other tests, stated researchers.

Health Canada has approved Precision Biomonitoring’s thermostable TRIPLELOCK™ test strips for use across the country. The TRIPLELOCK™ test strips are used as part of rapid diagnostic RT-PCR testing, and can provide results for nine samples in one hour. The cost-effective Canadian-made test will target the second wave of Covid-19 infections in Canada. Precision Biomonitoring has also received funding from the Next Generation Manufacturing Canada (NGen) for further thermostable test manufacturing.

South Korea health officials have approved a new test that can detect Covid-19 and seasonal influenza in the same sample, reports AP. This is intended to curb the spread of the disease in hospitals as the pandemic stretches into the winter season. Experts believe the likelihood of a virus flare in the cold weather when people will stay indoors. The Korea Disease Control and Prevention Agency recently reported 118 new Covid-19 cases, mostly from Seoul.

9:55 am

Coronavirus company news summary – Truvian’s antibody tested validated in study – Novarad launches free Covid-19 AI diagnostic tool

A University of Chicago research study has validated the performance and accuracy of Truvian Sciences’ easy check Covid-19 IgM/IgG™ antibody test. The clinical study carried out by the researchers found high overall accuracy rates for SARS-CoV-2 virus antibody detection.

OraSure Technologies, a point-of-care diagnostic tests provider, announced that its subsidiary DNA Genotek has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its ORAcollect®·RNA saliva collection device for collecting, stabilising and transporting saliva samples containing SARS-CoV-2 RNA.

Novarad, a transformative imaging technologies company, has launched a new Covid-19 artificial intelligence (AI) diagnostic tool to advance Covid-19 diagnosis worldwide at no cost. The diagnostic assistant was developed in collaboration with Intel Corp., leveraging Microsoft Azure’s cloud computing service to detect Covid-19 from CT scans. It is able to deliver results in seconds, coupled with information on lung conditions.

Assay Genie, a Dublin-based company, stated that it is close to launching a rapid Covid-19 antigen test that will be available in pharmacies. The company intends to sell the antigen tests at a cost of between $17 and $29, which is seven times cheaper than other tests available in the market. The test delivers results in 15 minutes with an accuracy rate between 92% and 98%.

9:30 am

Coronavirus company news summary – Netherlands orders BD antigen tests – Alveo receives grant to develop Covid-19 testing platform

The Dutch Ministry of Health has placed an order with BD (Becton, Dickinson and Company), a global medical technology company, to supply nine million of its rapid antigen tests for the BD Veritor Plus System that helps in detecting the SARS-CoV-2 infection in symptomatic individuals within 15 minutes. Approximately 1.2 million tests are expected to be delivered by mid-November.

The Institute of Inflammation, Immunology and Infectious Disease at Purdue University has collaborated with IdentifySensors Biologics, a technology firm, to develop a rapid diagnostic platform for detecting the SARS-CoV-2 virus and other pathogens. The platform will also detect infections such as influenza, dengue, Zika, HIV/AIDS, Lyme disease, hepatitis C, mumps, chickenpox, measles, foodborne pathogens, and methicillin-resistant staphylococcus Aureus (MRSA).

Hygea Precision Medicine, a precision medicine software company, announced that it has collaborated with testing-as-a-service (TaaS) provider to deliver Covid-19 saliva tests across the country, which are designed to be easy and convenient to administer remotely.

Alveo Technologies announced that it has been awarded a grant from the Bill & Melinda Gates Foundation to test the use and performance of its Covid-19 testing platform, be.well. If successful, the company will look to further its development and manufacturing of the platform, which the company says is as accurate as a PCR test while providing rapid test results via smartphones.

3:11 pm

NHS COVID-19 app failed to record potential exposures

England and Wales’ NHS COVID-19 contact tracing app has failed to alert users of potential exposures due to a programming error.

The wrong threshold for exposure was reportedly set on the app. When it should have recognised people as having been in close enough proximity to transmit the virus, it instead recorded that they were too far apart.

This means that many of the ‘phantom notifications’ being sent by the app, which Zühlke UK CEO Wolfgang Emmerich, whose team helped develop NHS COVID-19, recently told Medical Device Network indicated a ‘near-miss’, may have been genuine contacts.

9:28 am

Coronavirus company news summary – Hologic awarded US government contract to expand Covid-19 tests – Prenetics acquires Oxsed to scale rapid Covid-19 testing globally

Hologic has been awarded a $119 million US govrnmen contract for the expansion of its production capacity for Covid-19 molecular tests. The contract will support investments that will enable Hologic to deliver 13 million Covid-19 tests each month in the US by January 2022.

DNAFit, a subsidiary of Hong Kong-based Prenetics Limited, has acquired Oxsed, an Oxford University spinout which has developed the RaVID Direct Covid-19 test kit. Th kit has a 92% to 100% sensitivity, providing a scalable and low-cost option for Covid-19 testing that can be carried out anywhere and provide results within 15-30 minutes. DNAFit and Prenetics now have exclusive global rights to Oxsed technologies.

Credo Diagnostics has received a CE mark for its VitaPCR™ Influenza A&B/SARS-CoV-2 assay, a rapid molecular test that helps in detecting Covid-19, flu A and flu B infections from a single sample. The three-in-one test across Credo Diagnostics VitaPCR™ systems worldwide and delivers results within 20 minutes.

Celltrion USA, a subsidiary of Korean medtech firm Celltrion, has signed a contract to supply $22m worth of Covid-19 diagnostic tests to the US. The contract was signed following the issuing of Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for Celltrion’s SAMPINUT rapid antigen test kit. The kits will be distributed with exclusive rights in New York.

10:11 am

Coronavirus company news summary – Cipla launches ELIFast Covid-19 antibody test in India – EKF and Kantaro partner to market Covid-19 antibody testing in Europe

Cipla has announced the launch of its ELIFast Covid-19 antibody detection kits in India. The pharmaceutical company has partnered with KARWA to market and distribute the  test. The Indian Council of Medical Research (ICMR) has provided the technological know-how and process for development of the test kits.

Kantaro Biosciences and Bio-Techne have entered into a two-year agreement with EKF Diagnostics, a diagnostic testing company, to market and distribute Kantaro’s Covid-SeroKlir antibody test kit in Europe and Covid-SeroIndex for European research. Both the products have received CE Mark certification for detecting the amount of IgG antibodies in infected patients.

Victory Square Health (VSH), a portfolio company of Victory Square Technologies, announced that it has entered into a sales and distribution agreement to provide its 15-minute rapid testing kits and Safetest Covid-19 Elisa to Bulgaria, Cyprus, Greece, Romania, Serbia, and Northern Macedonia. The kits will also be made available to some regions in the Middle East.

GoGetTested has announced the availability of FDA-approved PCR Covid-19 testing in Columbia, South Carolina. GoGetTested will also open a Covid Response Operating System and mobile testing sites across the city, facilitating free tests for all South Carolina residents whether insured or not.

9:43 am

Coronavirus company news summary – Study identifies biomarkers for Covid-19 blood screening tool – Jiaotong University develops rapid Covid-19 testing system

Researchers from the Lawson Health Research Institute, Western University and University of Alberta study suggested that Covid-19 affects the concentration levels of specific metabolites in human blood. The team of researchers have identified three biomarkers that can be used an inexpensive and quick blood test to detect the presence of the virus in patients and predict patients likely to become critically ill.

Sixth Wave Innovations has received $250,000 from the Nova Scotia Covid-19 Response Council (NSCRC) to develop its Accelerated Molecularly Imprinted Polymer (AMIPs™) technology for rapid Covid-19 testing. The company aims to incorporate the technology into many rapid virus test kits, and in air and water monitoring schemes.

A Jiaotong University team has released a rapid screening test solution to detect the SARS-CoV-2 virus. The five-minute test helps identify antibodies against new coronary pneumonia. The test analyses the degree of the infection, a recent or prior infection, with the presence of the antibodies that can help in further diagnosis and treatment of the patient.

ICT International announced that it is making rapid antigen testing available to the UK and European markets. The test does not require expensive equipment or laboratories.

9:22 am

Coronavirus company news summary – PerkinElmer receives CE Mark for RT-PCR panel – Rosti to manufacture 15-minute Covid-19 test

PerkinElmer, a diagnostics and imaging company, has received CE Mark approval in the EU for its PKamp™ Respiratory SARS-CoV-2 RT-PCR panel. The panel allows for the detection of SARS-CoV-2 and other influenza viruses in a single test. It is currently under review by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).

Ginkgo Bioworks has secured supply to the SD Biosensor rapid antigen test. The company will distribute the test through its Concentric Covid-19 testing service in international markets where the test is approved. Ginkgo aims to acquire and distribute up to 50 million tests.

Rosti Group, a contract manufacturer, has formed a collaboration with Global Molecular Diagnostics to produce a Covid-19 saliva test capable of delivering accurate results within 15 minutes. The test will enable fast and on-site detection of SARS-CoV-2 virus even by non-medical personnel.

Ortho Clinical Diagnostics has received CE Mark approval for its VITROS® SARS-CoV-2 antigen tes. The test is suitable for mass testing and deliver results with a specificity of 99.2%. Ortho has also submitted an EUA application for the test with the FDA.

Helix, a genomics company, has received expanded EUA from the FDA for its HelixⓇ Covid-19 test, which is indicated for testing asymptomatic individuals. The expanded approval enables individuals to self-collect samples without the need for supervision by healthcare professionals.

9:38 am

Coronavirus company news summary – Genesprint Group and Infrawear introduce Covid-19 swab test in EU – Imec to develop SARS-CoV-2 test based on exhaled breath

Celltrion, a biopharmaceutical company, has received emergency approval from the US Food and Drug Administration (FDA) for its Covid-19 antigen diagnosis kit Sampinute. The testing kit uses a proprietary antibody-antigen technology, which delivers results in less than 10 minutes. Compared to existing RT-PCR tests, the Sampinute kit can deliver results with 94% accuracy.

Genesprint Group, a testing company, and Infrawear, testing and antibody kits provider, announced plans to introduce rapid antigen throat and mouth swab test for Covid-19 in the Europe. The test is CE marked and can deliver results in right minutes with 99.99% specificity.

Imec, a research and innovation hub, has commenced the development of a new test capable of detecting SARS-CoV-2 virus through a person’s exhaled breath. The test can deliver accurate results in less than five minutes. A prototype of the test is expected to be available for testing in 2021.

10:58 am

Coronavirus company news summary – Africa receives new Covid-19 rapid diagnostic tests – PocDoc launches Covid-19 workplace testing

In vitro diagnostics firm Todos Medical and biophrma company Adial Pharmaceuticals have developed the the Assure/FaStep® and EcoStep® point-of-care (POC) antibody tests. The tests received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in July this year, as antibody tests for the SARS-CoV-2 virus that indicated either recent or prior infection, but without fingerstick blood sample authorisation.

A collective of 20 African countries will receive new, World Health Organisation-approved antigen-based rapid diagnostic tests for the diagnosis of Covid-19. Testing has not been sufficient in many African countries, with only 12 in the region reaching the key threshold of 10 tests per 10,000 people every week in the last month. Currently the two tests which WHO has approved for emergency use are the standard Q COVID-19 Antigen Test by SD Biosensor Inc and the Panbio COVID-19 Antigen Rapid Test Device, both manufactured by Abbott.

PocDoc, a digital health firm, has launched a testing service that will help Brits get back to work more safely, reports City A.M.. The finger prick test delivers results within 10 minutes, detecting Covid-19 infection, as well as the presence of antibodies indicative or a prior infection. The tests are being manufactured by BioSure, a diagnostic solutions provider in the UK.

11:09 am

Coronavirus company news summary – SteriPack Group announces global rollout of sterile swabs – Primo Nutraceuticals signs on for exclusive Covid-19 rapid test marketing rights

The Indian Council of Medical Research (ICMR) has approved the efficacy of IIT Karagpur‘s COVIRAP diagnostic machine for detecting Covid-19 infection. The novel testing technology has been validated for its accurate molecular diagnostic procedure and is low cost and easy to conduct. Several commercial units have approached the Institute for rapid expansion of the technology.

CerTest Biotec and BD have recieved a CE mark for the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for the BD MAX™ System. The new kit can enhance Covid-19 testing to run as either individual or combined detection of influenza and respiratory viruses.

The Bill & Melinda Gates Foundation has awarded a $852,000 grant to SteriPack Group to accelerate the production of sterile nasal swabs used for Covid-19 tests. The company currently produces 20 million sterile swabs per month and is expected to expand its capacity, thereby facilitating new job opportunities at its facility.

Primo Nutraceuticals, an investment company, has signed a Memorandum of Understanding (MOU) with Neo-Nostics for the exclusive rights to market the Neo-Nostics 2019-nCoV IgG/IgM Rapid Test Kit in Canada. The MoU is effective from October 2020. Primo will receive the “Official Dealer/Distributor Status” once Neo-Nostics ™ gets the license and approval from Health Canada.

9:17 am

Coronavirus company news summary – Centogene receives EUA for RT-PCR assay – Thermo Fisher increases availability of testing with Everlywell sample collection kit

Centogene has announced that the company has recieved US Food and Drug Administration (FDA) approval for the issuance of Emergency Use Authorization (EUA) for its proprietary SARS-CoV-2 RT-PCR test called the CentoSure. The EUA allows the administration of the test for individuals who are not suffering from any COVID-19 symptoms, and to accelerate testing worldwide.

OraSure Technologies has announced that its DNA Genotek subsidiary received EUA for the use of its OMNIgene® oral saliva collection device. The at-home test kit is the first FDA approved device that can be collected and safely used by individuals at home and without the presence of any healthcare professional or in a healthcare setting.

Thermo Fisher Scientific has announced that it has received authorisation for the expansion of its EUA for the TaqPath COVID-19 Combo Kit, along with a home sample collection kit by Everlywell, a digital health testing company. The combined kit allows individuals to collect nasal swabs samples when instructed by a healthcare provider and after receiving the results of a COVID-19 questionnaire.

Beroni Group has collaborated with GenScript Biotech Corporation for the successful completion of a SARS-CoV-2 pseudovirus neutralisation assay. The assay helps fight the virus by targeting Covid-specific nanobodies and testing their affinity and efficacy, to try an prevent future infections.

9:39 am

Coronavirus company news summary – BD announces approval for immune assessment assay – Oceanit readies rapid COVID-19 test developed in Hawaii

BD has announced that its BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes has received the CE mark and distribution approvals to assess immunity among Covid-19 patients in Europe. The product is expected to help clinicians better understand immune responses to the Covid-19 disease.

Researchers from the Indian Institute of Science Education and Research in Pune, India have developed a new test to measure the loss of smell quickly and accurately in Covid-19 patients. A specially developed olfactory action meter was used by the researchers to identify the virus in individuals having no additional symptoms such as fever or fatigue. The test identified olfactory deficits in 82% of the 34 asymptomatic patients.

Softlab9 Technologies, a software solutions company, announced that it has procured 1,000 rapid antigen Covid-19 testing kits from Zhejiang Orient Gene Biotech, a Chinese biotech company. The RA test kits can detect the virus from saliva samples within 15 minutes. The kits are approved in the US, Australia, and Europe, but not yet in Canada where the company is based.

Oceanit Laboratories, a biotech company, is planning to file an application for approval with the US Food and Drug Administration (FDA) for a Covid-19 test developed in Hawaii. The test provides results within three to ten minutes and is expected to cost between $5 to $20. The company expects to receive approval within the next few weeks although availability of the test could take a few months.

9:53 am

Coronavirus company news summary – Oxford scientists develop extremely rapid diagnostic test for COVID-19 – bioLytical Laboratories launches INSTI® COVID-19 antibody test

Oxford University scientists have developed a diagnostic test capable of detecting the SARS-CoV-2 virus in five minutes. The test can differentiate between and negative samples or other respiratory pathogens such as influenza. It works directly on the throat swabs from Covid-19 patients, and quickly labels the virus particles on the sample with the help of fluorescent DNA strips.

Genalyte, a healthcare analytics and diagnostics company, has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 multi-antigen serology panel. The test identifies IgG and IgM antibodies produced by the body to fight the SARS-CoV-2 virus. The panel, along with the FDA-approved Maverick™ Diagnostic System, is expected to improve antibody testing and deliver accurate results in 20 minutes.

bioLytical Laboratories, an HIV diagnostic products company, has launched a one-minute antibody test for Covid-19 in Europe after receiving CE mark approval. The test uses flow-through technology to deliver fast results. bioLytical aims to start manufacturing of the new test kits and rapidly distribute them across the globe.

Chembio Diagnostics, a diagnostic company, has submitted an Emergency Use Authorisation (EUA) application for the DPP SARS-CoV-2 antigen test system to the FDA. The test system can detect SARS-CoV-2 antigens in 20 minutes and includes an antigen test cartridge, a nasal swab, and a micro reader optical analyser.

10:14 am

Coronavirus company news summary – Siemens Healthineers launches rapid antigen test for SARS-CoV-2 – Researchers develop new score to predict severity of infection in Covid-19 patients

Siemens Healthineers is launching a rapid antigen test to detect SARS-CoV-2. The CLINITEST Rapid COVID-19 Antigen Test can identify infected people in 15 minutes, is easy to use, and will be launched in CE mark countries. The company also has plans to submit the antigen test to the US Food and Drug Administration (FDA) for emergency use authorisation.

Scientists from the RCSI University of Medicine and Health Sciences have developed a new score that will help predict the severity of the infection in Covid-19 patients. The Dublin-Boston score, as it is called, allows clinicians to make better decisions when advising patients on the use of steroids, or admission to intensive care units. The novel score can accurately predict the severity of the infection on the seventh day, after measuring patients’ blood samples in the first four days.

Centogene, a commercial-stage company focused on rare diseases, and U-Diagnostics, a medical laboratory, have collaborated to provide increased Covid-19 testing capacities in the Netherlands. The partnership is a result of the growing number of cases and limited testing capacities in the country. As per the agreement, U-Diagnostics will offer increased testing services, while Centogene will provide the CentoSwab swabbing solution, and the samples will be tested in Centogene laboratories

Paragon Genomics, a provider of amplicon-based target enrichment solutions, has developed a new coronavirus-related CleanPlex next-generation sequencing (NGS) tests. The CleanPlex ACE2 and TMPRSS2 Panel evaluates the differences in patients’ genetic vulnerability to the infection and to develop severe form of the disease. CleanPlex technology is expected to produce accurate and informative results in about five hours and with efficient workflow and low sequencing costs.

10:31 am

Coronavirus company news summary – Roche to launch SARS-CoV-2 antigen test – FDA clears Access Bio’s 10-minute CareStart test kit

Roche is set to launch a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigen test to provide further support in the diagnosis and treatment of Covid-19 patients. The Elecsys SARS-CoV-2 antigen test runs on the widely available cobas e immunochemistry analysers. The test is expected to be made available by the end of 2020 in markets accepting the CE mark.  Roche also plans to file for Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA).

Texas-based biotechnology company Angstrom Bio has announced the launch of a Covid-19 and respiratory pathogen testing platform, enhanced by machine learning and nanopore sequencing, which is designed to facilitate high-accuracy, high-volume, low-cost tests. Angstrom has partnered with local organisations, schools and businesses to implement safe and cost-effective testing programmes. The company intends to deliver 1,000,000 online results per day in 2021.

The US Food Drug and Administration (FDA) has cleared a 10-minute Covid-19 test manufactured by New Jersey-based Access Bio. The CareStart Covid-19 antigen test is a lateral-flow immunochromatographic assay that detects protein antigens specific to SARS-CoV-2 from samples extracted by nasopharyngeal swab. The assay has reached 88.4% sensitivity and 100% specificity in clinical testing, and can be conducted at the point of care by non-medical professionals.

Ohio-based VEO Diagnostics has announced the launch of the ACCEL ELISA Covid-19 kit in the US. This assay can detect the total antibodies to the Covid-19 virus in serum. The solution aims to identify people with an adaptive immune response to the coronavirus, indicating either recent or prior exposure to the virus. The serology test, to which VEO Diagnostics has sole US distribution rights, is manufactured by South-Korea headquartered Plexense, and is designed to improve access to testing and improve the turnaround time of antibody testing by reducing the total incubation period to 30 minutes.

10:48 am

Coronavirus company news summary – Thermo Fisher introduces two Covid-19 antibody tests – FDA issues EUA for Abbott’s serology test

Applied DNA Sciences subsidiary Applied DNA Clinical Laboratories has won contract for Covid-19 surveillance testing under its testing-as-a-service offering. This offering is expected to generate a total annualised revenue of over $1m.

Thermo Fisher Scientific has announced the launch of two new SARS-CoV-2 antibody tests, the Thermo Scientific OmniPATH Covid-19 Total Antibody ELISA test and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. OmniPATH Covid-19 Total Antibody ELISA test has received the Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). The EUA for the EliA SARS-CoV-2-Sp1 IgG test is under review by the FDA. Currently, the test is available under the FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).

BioGX has received EUA from the FDA for an extraction-free, direct sample addition RT-PCR test to detect SARS-CoV-2 viral RNA in patients. The Xfree Covid-19 Direct RT-PCR test is a complete test in a single vial, lyophilized in BioGX Sample-Ready format.

Abbott has received EUA from the FDA for its AdviseDx SARS-CoV-2 IgM lab-based serology test. The test is designed to be used on the ARCHITECT and Alinity platforms. Abbott has received EUA for seven Covid-19 tests since the start of the pandemic.

9:33 am

Coronavirus company news summary – FDA provides EUA for Beckman Coulter’s IgM assay – India and Israel to develop rapid Covid-19 test

US Food and Drug Administration (FDA) has awarded Emergency Use Authorization (EUA) to Beckman Coulter’s Access SARS-CoV-2 Immunoglobulin M (IgM) assay. The assay has demonstrated specificity of 99.9% and sensitivity of 98.3%. It is a part of the diagnostic solutions suite developed by Beckman Coulter to help fight the Covid-19 pandemic.

India and Israel have partnered to develop a rapid Covid-19 testing technology that will provide the results within a minute, reports the Times of India. Israeli Ambassador to India Ron Malka has reportedly stated that the test will be available in ‘a matter of days’. Individuals must blow into a tube for the test, following which the results are provided.

Medtronic has donated personal protective equipment (PPE) worth around $1m, to the International Medical Corps to aid its efforts to fight the Covid-19 pandemic in continental US and Puerto Rico. The donation comprises of over 1.1 million surgical masks and 408,000 KN95 respirators which will be provided to over 15 hospitals and health facilities.

Oxford Nanopore Technologies has announced that its LamPORE test to detect the Covid-19 causing SARS-CoV-2 virus, has received the CE-IVD mark. The test is performed on the GridION, which is a desktop device or on MinION Mk1C, which is a palm-sized device. The company is now working to receive regulatory approvals in the US and UAE.

9:41 am

Coronavirus company news summary – Real-Time Analyzers develops rapid Covid-19 saliva test – Wales lab becomes first facility brought online by PerkinElmer

Exogenesis has announced that its Exogenesis Surgical Mask (ESM) has achieved primary endpoints of trapping and deactivating Covid-19 viral particles in simulated real-world exposures during a series of challenge tests. The ESM is intended to offer protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The ESM is not approved for commercial distribution but the company expects to make premarket regulatory filings soon.

Hawkeye Systems has announced that its manufacturing partner DemeTECH has secured NIOSH certification for its line of US manufactured N95 Masks. The company has secured guaranteed, uninterrupted production capacity on production lines.

IsoPlexis has announced a partnership with Yale University to use its functional immune landscaping and high-plex automated immunoassay solutions to identify several predictive markers of immune response to Covid-19. It is hoped that this work will provide critical functional insights into the mechanisms of various immune responses to Covid-19 and help to accelerate the development of critical therapeutics and vaccines.

Real-Time Analyzers (RTA), a developer of chemical and biological agent analysers for the US military, has developed a saliva-based Covid-19 test kit. The COVID-19 Saliva Antigen Test kit includes a straw-like tube to gather and transfer saliva to a sample vial, to which buffer is then added in order to inactivate the virus in the saliva, and a pipette to transfer a few drops to a pregnancy-style test strip. Saliva flows across the strip, and generates a test result in 15-20 minutes. One visible line on the strip indicates that the user is not infected and two visible lines indicate that the user is infected.

PerkinElmer has announced that the Lighthouse lab in Newport, South Wales is now processing Covid-19 testing samples as part of the company’s collaboration with the Department of Health and Social Care (DHSC) in support of the UK Government’s Test and Trace strategy. The Newport lab is claimed to be the first facility to be brought online by PerkinElmer with the DHSC.

10:56 am

Coronavirus company news summary – Sonic Healthcare USA launches multiplex assay for Covid-19 and flu – Abbott reveals interim clinical data results on ID NOW COVID-19 rapid test

ZEUS Scientific has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its in vitro ELISA diagnostic test for identifying IgG antibodies to the SARS-CoV-2 virus in human serum and plasma. Currently, this test is in stock and is available to all clinical labs. The assay makes use of a dual antigen combination of recombinant S1 receptor-binding domain (RBD) viral protein and recombinant nucleoprotein in order to optimal performance.

Sonic Healthcare USA has introduced a multiplex RT-PCR assay that brings together testing for SARS-CoV-2 (COVID-19) and Influenza A/B with one specimen collection. This offering complements the firm’s current Covid-19 Testing Program that includes both RT-PCR and antibody testing.

20/20 BioResponse, a business unit of 20/20 GeneSystems, has begun accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits. These kits are claimed to be the first to receive EUA from the US FDA for point-of-care (POC) use with fingerstick blood samples on 23 September.

Abbott has revealed new interim clinical data results on its ID NOW COVID-19 rapid test, evaluated on a total of 1,003 people across both urgent care clinics and hospitals and nursing homes. According to the firm, the results confirm the data submitted to the US FDA in March for EUA and the interim results that was shared in May. The data also speak to the important role played by reliable point-of-care testing that is available in convenient and accessible locations where people can get immediate results.

9:35 am

Coronavirus company news summary – Hologic’s Aptima SARS-CoV-2 assay to now include testing of asymptomatic patients – Qosina teams up with Resolution Medical to offer 3D-printed sterile nasal swab

Hologic has announced that its Aptima SARS-CoV-2 assay, which secured Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) in May, is now authorised for testing of individuals who do not show symptoms but have reason to suspect Covid-19 infection. So far, Hologic has produced tens of millions of SARS-CoV-2 assays.

Quanterix, a company digitising biomarker analysis, has secured a Phase 2 contract from the National Institutes of Health (NIH) through its Rapid Acceleration of Diagnostics (RADx) initiative. This contract, which carries a total value of $18.2m, will speed up the development and deployment of SARS-CoV-2 antigen testing, based on Quanterix’ ultra-sensitive Simoa technology. According to preliminary results, the test has shown the potential to detect from a variety of sample types including self-collected capillary blood, saliva and nasal swabs.

Qosina now carries a sterile 3D-printed nasopharyngeal Covid-19 testing swab for nasal mucosa specimen collection. The 3D-printed sterile swab, developed by in vitro diagnostic and medical device manufacturer Resolution Medical, is claimed to be a cost-effective alternative to the conventional nasopharyngeal swab. It can be produced quickly through existing, industry-approved materials and the Carbon Digital Light Synthesis 3D printing process.

Medicom, a manufacturer of surgical and respiratory masks, has announced the expansion of its mask manufacturing operations in the US. The company will add a second factory with triple the square footage of its current United Medical Enterprise facility in Augusta, Georgia. This new facility will accommodate new surgical and N95-type mask production equipment.

10:00 am

Coronavirus company news summary – Qiagen to launch viral RNA epidemiology test – 3M launches initiative to prevent fraud amid Covid-19 pandemic

Qiagen has announced plans to launch a the QIAprep&amp Viral RNA UM Kit, which is designed to simplify and accelerate PCR swab analysis and remove key testing bottlenecks for Covid-19 and other RNA viruses. The kit combines a liquid-based sample preparation step completed in only two minutes with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing.

CLEAR and LabCorp have partnered to allow the CLEAR’s Health Pass mobile app users to link their LabCorp test results securely, with their LabCorp Patient account. This partnership will combine the testing capabilities, including Covid-19 tests, of LabCorp with CLEAR’s Health Pass technology, linking the digital identity of the person with the Covid-19 data to make the access to public spaces easier.

3M has launched a legal effort to prevent profiteers from taking advantage of the demand for its products for healthcare workers and first responders amid the Covid-19 pandemic. The company has set up hotlines to report suspected fraud cases and has also created online resources to identify spot price-gouging, detect authentic 3M respirators and to ensure that the products sold are from authorized distributors of the 3M products.

Cleanlife has announced that it donated 2,500 face shields to the University Hospitals Covid-19 Response Fund. Additionally, the company also provided a sponsorship at the 37th Annual Rainbow Golf Classic. These contributions are expected to safeguard frontline workers during the ongoing Covid-19 pandemic.

10:04 am

Coronavirus company news summary – BD’s Covid-19 antigen test receives CE Mark – Health Canada approves MVM ventilator has partnered with EHE Health to deliver saliva-based Covid-19 tests to self-insured employers in the US. EHE Health aims to provide resting kits to the clients which will allow them to deploy on-site testing portals. These measures are expected to lead to a safer work environment and will support the employees as they return to their workplace.

Avacta Group has announced that the BAMS assay that is used to identify the SARS-CoV-2 virus is being provided as a research kit by Adeptrix. Additionally, Bruker Scientific has presented the assay in a new application note. The bead-assisted mass spectrometry (BAMS) assay can be used by a technician to analyse up to 1,000 samples each day, providing a high throughput technique for the diagnosis and research of Covid-19.

BD’s rapid, point-of-care, SARS-CoV-2 antigen test that is designed to be used on the BD Veritor Plus System has received the CE mark to the IVD Directive (98/79/EC). Capable of providing results in 15 minutes, the test delivers the results on a portable instrument. This is said to be beneficial for the turnaround time for Covid-19 diagnostics, as results are available when the patient is still present on the testing site.

Health Canada has approved Vexos’ Mechanical Ventilator Milano (MVM) ventilator under its Interim Order. This May, the company signed a contract with the Canadian Government for the manufacture and supply of around 10,000 MVM units. Vexos plans to commence the shipping the MVM ventilators to Canada.

9:55 am

Coronavirus company news summary – Health Canada authorises Guide Sensmart’s fever warning system – UNICEF takes delivery of Covid-19 test kits

Health Canada has added the Guide IR236 IR Fever Warning System, which is manufactured by Guide Sensmart, to the list of medical devices authorised for Covid-19 use. The automated infrared thermal imaging system provides smart, quick and accurate temperature screening. It is hoped it can help identify people who may have a fever, to reduce the spread of the pandemic.

Swift Biosciences has announced that it will be the exclusive distributor of BillionToOne‘s RNA extraction-free Covid-19 Test Kit. The kit, which has recieved Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA), is identifies the Covid-19 virus in specimens from nasal swabs, nasopharyngeal swabs, or oropharyngeal swabs.

The United Nations Children’s Fund (UNICEF) has taken the delivery of 115,800 Covid-19 test kits to aid in the mitigation of the Covid-19 pandemic in Nigeria. IHS Towers’ Nigerian subsidiary, IHS Nigeria funded the supplies.

BioGX BV has launched a CE-IVD marked test for detection of the Covid-19 causing SARS-CoV-2 virus, as well as Influenza A, Influenza B and respiratory syncytial virus RNA. The test will be carried out using the BD MAX System. It is provided in the BioGX’s Sample-Ready™ format, with the reagents that are needed for the for real-time PCR lyophilised in one tube.

12:26 pm

Smartphone app used to analyse coronavirus genome

A new mobile app has made it possible to analyse the genome of SARS-CoV-2, the virus that causes Covid-19, on a smartphone in less than half an hour.

Genopo, developed by the Garvan Institute of Medical Research, in collaboration with the University of Peradeniya in Sri Lanka, is designed to make genomics more accessible in resource-limited settings.

The app was tested using raw sequencing data of viral RNA swab samples from nine patients with Covid-19. It took an average of 27 minutes to determine the complete SARS-CoV-2 genome sequence from the raw data, which opens the possibility of doing genomic analysis at the point of care, in real time.

Garvan’s Kinghorn Centre for Clinical Genomics head Dr Ira Deveson said: “Not everyone has access to the high-power computing resources that are required for DNA and RNA analysis, but most people have access to a smartphone.

“Fast, real-time genomic analysis is more crucial today than ever, as a central method for tracking the spread of coronavirus. Our app makes genomic analysis more accessible, literally placing the technology into the pockets of scientists around the world.”

10:44 am

Coronavirus company news summary – US to distribute 150 million rapid Covid-19 tests in coming weeks – Hologic’s Panther Fusion SARS-CoV-2 assay gets FDA EUA

US President Donald Trump has announced plans for the distribution of 150 million rapid Covid-19 tests in the weeks to come. This announcement is aimed at reopening the economy. Out of the 150 million tests, 50 million tests will be allocated for vulnerable communities, including nursing homes; assisted living facilities, and health and hospice care agencies. The rapid tests give results in 15 minutes.

Hologic’s Panther Fusion SARS-CoV-2 assay has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration for the testing of individuals showing no symptoms or other reasons to suspect Covid-19 19 infection. The high-throughput molecular diagnostic test is specifically authorised for screening asymptomatic people.

Quotient Limited has received EUA from the US FDA for its Covid-19 antibody test, which can identify antibodies produced in humans in response to the SARS-CoV-2 virus. This test uses Quotient’s proprietary MosaiQ blood testing microarray technology. It CE mark on 1 May and is now available in both Europe and the US.

India’s CRISPR ‘Feluda’ Covid-19 test is claimed to be more accurate than a rapid antigen test and almost as quick, reported the Press Trust of India. It alters colour on identification of the SARS-CoV-2 virus and is claimed to be cheaper option than RT-PCR diagnosis.

9:37 am

Coronavirus company news summary – FDA provides EUA for first point-of-care antibody test – PurpleSun introduces disinfection technology

The US Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for the first serology point-of-care test for Covid-19. The test, Assure‘s Covid-19 IgG/IgM Rapid Test Device, previously received authorized for emergency use by certain labs in July to detect those who developed SARS-CoV-2 antibodies, which indicates recent infection. The FDA has now resissued the EUA to approve the test for POC use with the use of fingerstick blood samples.

PurpleSun has introduced its PurpleSun E300 system which uses Focused Multivector Ultraviolet (FMUV) light technology to disinfect within 90secs. The PurpleSun E300 can be used to disinfect equipment and rooms as the people inside continue to work around the system safely. PurpleSun has also partnered with Hackensack Meridian Health and Northwell Health to provide government agencies with the decontamination technology.

Vela Diagnostics has received the an EUA from the FDA for its ViroKey SARS-CoV-2 RT-PCR Test v2.0. The test is an automated probe-based reverse transcription PCR test that can identify the Covid-19 causing SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swabs. CLIA certified laboratories in the US can use the test to detect Covid-19.

CapsoVision has announced that US Food and Drug Administration will provide enforcement discretion to permit the use of CapsoCam Plus small bowel capsule endoscope for patients amid the Covid0-19 pandemic. With this addendum, fully remote capsule endoscopy procedure can be carried out for eligible patients who are monitored at home. This will eliminate the need for in-person interaction which reduces the risk of infection.

9:35 am

Coronavirus company news summary – Eurobio Scientific launches Covid-19 test – Liberate Medical chooses MedCrypt’s API to secure respiratory muscle stimulators

DetectaChem, a provider of portable threat detection solutions, has announced that its MD-Bio (MobileDetect Bio) BCP19 Test Pouch for Covid-19 detection successfully passed the initial Deep Dive phase in July and is advancing through Phase 1 of the NIH (National Institutes of Health) RADxSM (Rapid Acceleration of Diagnostics) Tech initiative.

French in-vitro medical diagnostics and life sciences organisation Eurobio Scientific has launched a rapid diagnostic test to detect the SARS CoV-2 virus antigen. The Sofia SARS Antigen, developed by its US partner Quidel, is complementary to PCR tests that remain the performance gold standard with regard to detection of the coronavirus. Already CE marked, it is now available for sale.

Liberate Medical has selected MedCrypt’s API to help secure its VentFree Respiratory Muscle Stimulator, a medical device that may cut down the number of days adult patients need mechanical ventilation, including patients with Covid-19. Liberate Medical secured an emergency use authorization from the US FDA for its VentFree Respiratory Muscle Stimulator in May, enabling an early launch into the market.

Atomo Diagnostics has signed an agreement with PinkTech Design Private (DIVOC) to roll out its Covid-19 antibody test in India. On non-exclusive basis, DIVOC will distribute the AtomoRapid Covid-19 test to government and corporate entities besides home-visit network in the country.

9:25 am

Coronavirus company news summary – STChealth and partner for Covid-19 testing – FDA provides EUA for personal PCR device

STChealth has partnered with to offer saliva-based Covid-19 tests as part of its strategic alliance to provide a national, comprehensive return-to-work program for employers. STChealth has also partnered with Bridge Purchasing Solutions, Newmark Knight Frank and CuraLinc Healthcare to form ‘The Strategic Actions for Employers (SAFE) Program’, which aims to empower organisations to safeguard their employees amid the Covid-19 pandemic.

CytoSorbents has announced that its CytoSorb blood purification technology that is used to treat cytokine storm and inflammations has received medical device registration from the Brazilian Health Regulatory Agency (ANVISA). With this registration, CytoSorb is available in the country to treat cytokine storm in cardiac surgery and major illnesses including Covid-19. Contatti Medical will distribute the device.

The US Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for Visby Medical‘s single-use Personal PCR device, a rapid test to detect Covid-19. The palm-sized device produces results within 30 mins.

Ortho Clinical Diagnostics has announced its continued partnership with the Biomedical Advanced Research and Development Authority (BARDA) under a new contract as a part of the US Government’s and BARDA’s effort against the Covid-19 health crisis. Ortho received $12.85m from BARDA to aid its antigen test development and provide regulatory pathway support for total and IgG antibody tests.

8:42 am

Coronavirus company news summary – Roche introduces Covid-19 antibody test for CE Mark countries – FDA reissues EUA for Abbott ID Now Covid-19 test

Roche has launched its Elecsys Anti-SARS-CoV-2 S antibody test in CE mark territories. The company has also applied for the Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA). The test is designed to measure the number of antibodies present in people who have been exposed to the SARS-CoV-2 virus. It targets antibodies related to a specific region of the viral spike protein that aids in the binding to the host cell receptor.

The Drugs Controller General of India has given its approval for the launch of Tata CRISPR Covid-19 test, ‘Feluda’. The low-cost test uses CRISPR technology to detect the genomic sequence of the SARS-CoV-2 virus. It provides the results within two hours and is said to have a sensitivity of 96% and specificity of 98%. The test was developed by the Council of Scientific and Industrial Research, Institute of Genomics and Integrative Biology and the Tata Group.

The FDA has reissued the EUA for the Abbott ID Now Covid-19 test. As per the revised EUA, the test is to be used for samples collected from people who are suspected to have Covid-19 within the first week of the onset of symptoms. The test is now authorised for CLIA-certified laboratories and needs to adhere to the needs to carry out high, moderate, or waived complexity tests.

9:30 am

Coronavirus company news summary – Siemens teams up with Testing for America – CVS Health to add over 2,000 new Covid-19 drive-thru test sites

QuestDirect, the consumer-initiated testing business of Quest Diagnostics, has announced that its QuestDirect COVID-19 Active Infection test can be purchased online with specimen collection available in two ways: at-home or at one of over 500 Walmart Neighborhood Market drive-thru pharmacy locations across the US.

The Siemens Foundation and Siemens Healthineers are partnering with Testing for America to donate $500,000 in funding and an in-kind donation of Covid-19 testing technologies, with a market value of $2,275,000, to support the safe reopening of historically black colleges and universities across the US.

Experts from Seattle Children’s Hospital believe that Covid-19 is triggering Kawasaki disease in some cases. Prevencio has now announced the development of a blood test, HART KD for diagnosis of Kawasaki disease. The firm collaborated with Seattle Children’s Research Institute and tapped its Artificial Intelligence (AI)-driven HART platform and expertise in developing cardiac blood tests. Kawasaki disease causes inflammation in the walls of arteries throughout the body and mostly occurs in children younger than five years old.

CVS Health has announced plans to add over 2,000 new Covid-19 drive-thru test sites at select CVS Pharmacy locations across the US to support the ongoing efforts to increase access to testing to help contain the spread of the virus. CVS Health is claimed to currently manage the largest number of independently run Covid-19 test sites in the country. The company expects to have more than 4,000 operating by mid-October.

9:19 am

Coronavirus company news summary – Color receives EUA for Covid-19 self-collection kit – Vivera Pharmaceuticals launches BIOZONE device

AXIM Biotechnologies has filed an Emergency Use Authorisation (EUA) application with the US Food and Drug Administration (FDA) for its first-in-class rapid diagnostic test for Covid-19. AXIM’s rapid diagnostic test is expected to be the market’s first Covid-19 rapid diagnostic test which measuring levels of functional neutralising antibodies in a lateral flow assay format.

Color has secured EUA from the FDA that allows CLIA-certified laboratories designated by the company use its self-swab Covid-19 collection kit. Patients will be able to collect their own samples at home, or onsite at workplaces or other congregate settings, without needing healthcare professionals to monitor the sample collection process.

DexCom has launched a registry to track the outcomes of patients using continuous glucose monitoring (CGM) in hospitals in response to the Covid-19 pandemic. Given the requirement to preserve personal protective equipment, minimise potential hospital staff exposure to Covid-19 and reduce the overall burden on nursing care, the Dexcom G6 CGM system has been made available to remotely monitor the glucose levels of all hospitalised patients during the Covid-19 pandemic.

Vivera Pharmaceuticals has launched BIOZONE, a device for sanitisation in high occupancy settings. This device features facial recognition, integrated biometrics, and a hospital grade organic sanitisation mist. It can detect body temperature, assign custom profiles for users, and offer surface disinfection of clothing and personal belongings. Vivera Pharmaceuticals chief medical officer Dr. Stephen McColgan said: “Public health requires a stepwise approach to comprehensive Covid-19 containment.”

9:46 am

Coronavirus company news summary – ZandCell launches saliva based coronavirus test – FUJIFILM Sonosite and CHEST Foundation announce joint grant for Covid-19 research

Thermo Fisher Scientific has announced an investment of over $140m to expand its laboratory plastics consumables production to support demand for Covid-19 testing, besides development and manufacturing of therapies and vaccines. Among the Thermo Fisher sites being expanded are Rochester in New York; Petaluma, California; Monterrey and Tijuana of Mexico; and Joensuu in Finland.

Innatoss Laboratories has announced a neutralising antibody public testing service against SARS-CoV-2 in Europe, using GenScript’s cPass SARS-CoV-2 Neutralization Antibody Detection Kit. This kit is claimed to be the first in the world to allow quick detection of neutralizing antibodies (NAbs), the particular specific antibodies present in the serum of COVID-19 patients that are responsible for clearing the viral infection. Innatoss is the first medical lab in Europe to provide a service of this kind for the public.

ZandCell, a biotechnology firm, has launched the saliva-based ZandCell COVID-19 Rapid Antigen Test. This kit is available in large quantities to be used in airports, governments, cities, hospitals, healthcare workers and, sports events, to quickly and effectively test patients for the infectious virus and provide immediate results within a few minutes.

FUJIFILM Sonosite, a provider of point-of-care ultrasound (POCUS) solutions, and the CHEST Foundation, the charitable foundation of the American College of Chest Physicians, have announced joint grant in creating the CHEST Foundation Research Grant in Ultrasonography and COVID-19. The aim of this grant is to look into the role of POCUS technology on COVID-19 patients through clinical research.

9:33 am

Coronavirus company news summary – Sanolla receives EU funding for Covid-19 AI – EU tests technology platform to link tracing apps

Sanolla, an Israel-based medical device and technology start-up, has been granted EU funding under the Horizon 2020 programme to help address coronavirus pandemic. After its earlier announcement, Sanolla shifted its technology to support the early detection and monitoring of Covid-19, enabling doctors to quickly evaluate and diagnose patients with its artificial intelligence based smart auscultation device. Sanolla set up a consortium with seven European entities and companies. Sanolla and its partners have been granted a total of €5m funding for the project, under the Horizon 2020 programme.

Meridian Bioscience, a provider of diagnostic testing solutions, has announced the launch of a novel SARS-CoV-2 antibody pair to the trimeric spike protein to speed up development of Covid-19 assays from patient saliva. Coronavirus-neutralizing antibodies mainly target the trimeric spike (S) glycoprotein on the viral surface that mediates entry into the host cell. This antibody pair binds to recombinant SARS-CoV-2 trimeric spike protein.

Many countries in Europe have begun testing a technology platform that will enable national coronavirus tracing apps to ‘talk’ to one another in order to better address the Covid-19 pandemic. The European Commission has begun test runs between the servers that support the apps made by the Denmark, Germany, Czech Republic, Ireland, Latvia and Italy. These apps not only share a similar design but also exchange data between them, reported Reuters.

Canada-based LuminUltra has submitted its GeneCount Covid-19 RT-qPCR Assay Kit (Covid-19 Assay) to the US FDA for emergency use authorisation (EUA) and to Health Canada for an interim order (IO). This authorisation will enable LuminUltra to provide a complete clinical Covid-19 testing solution that can be customised for testing facilities across North America.

5:00 pm

Workplace social distancing and contact tracing wearable launched

Nymi has launched the third version of its workplace wearable wristband, a password-free technology designed to ensure the health and safety of personnel across multiple industries.

The Nymi band has a long battery life, cannot be breached from the Internet and is cleanable to standards that make it useful in secure environments. For social distancing and contact tracing, the Nymi Band’s location sensing function determines the proximity to other Nymi Bands and alerts each user of distancing events. For contact tracing, Nymi services can store contact logs for authorised personnel to both understand and stem the spread of contagious diseases like Covid-19.

The band secures individual users’ identities by using their unique fingerprint and heart rhythm to bind them to the band, employing on-body detection technology to ensure the band is always being worn by the intended user.

“Many organizations operate in extremely complex and regulated environments that make digital transformation, security and now, with Covid-19, health and safety for every worker a challenge,” said Nymi CEO Chris Sullivan. “With Nymi, you get a safer, more productive and more secure way to come back to work.”

9:48 am

Coronavirus company news summary – BRS to manufacture medical devices – FDA adds Todos’ Covid-19 test to Notified List

Blackbriar Regulatory Services (BRS) has announced its entry into the manufacture of medical devices and production of face masks to help tackle the Covid-19 pandemic. BRS aids small and mid-sized companies to introduce the  US Food and Drug Administration (FDA)-approved products into the market, and also offers regulatory and scientific services. It stated that it has wide-ranging manufacturing experience in the highly regulated industries and understands the product requirements of the FDA.

Lord Global Corporation has partnered with KeyOptions to market the Virolens testing unit in other markets. Lord Global received the rights to market it in Australia, Latin America, South East Asia, Turkey and other territories along with other partners. The Virolens system is a screening device for Covid-19 which is based on microscopic holographic imaging and artificial intelligence (AI) software technology. It analyses the saliva samples using a digital camera attached to a microscope.

XIFIN has announced that it will work with laboratories to respond to the need for more testing and technology to handle the testing with the introduction of its cloud-based laboratory information system, XIFIN LIS 7. The platform is equipped with new features which support high complexity, high volume labs, such as integrated speech recognition.

The FDA has added Todos Medical’s TODOS 2019-nCoV RT-qPCR Detection Kit to the Notified List under the Emergency Use Authorisation (EUA) programme. With this addition, the company needs to submit an application for the EUA to the FDA within 15 days after the notification is submitted. Currently, the test is approved to use the QuantStudio 12Flex Instrument to perform the RT-PCR assay. The initial shipments of test kits to the CLIA laboratory clients is expected to commence next week.

11:45 am

GlobalData Epidemiologist Report: Global Covid fatalities near 910,000 – infections pass 28.1 million

11 September

Globally, the total confirmed cases of Covid-19 have reached over 28,170,000, with more than 909,000 deaths and 18,995,000 recoveries.

Worldwide, daily confirmed cases continue to increase.

This is primarily driven by increasing cases observed in Latin America, the US, and India.

Cases are rising alarmingly in India with no indication to suggest that cases will decline in the near future.

Argentina is reporting an increasing trend of Covid-19 cases in Latin America.

In Europe, France and Spain are reporting high numbers of new daily cases.

Total confirmed cases collectively in Africa are very low with only South Africa among the top 30 most affected countries globally.

South Africa is reporting a steady decline in daily new cases in recent days.

However, countries such as Tunisia and Morocco have reported increasing trend of daily new cases.

Bishal Bhandari, PhD, Senior Epidemiologist at GlobalData  

9:52 am

International update: Global Covid cases pass 28.1 million – Western Europe a new hotspot

11 September

Global: Worldwide Covid-19 cases have now passed 28.1 million, with deaths exceeding 909,000 according to Johns Hopkins University.

Latin America: The number of confirmed coronavirus infections topped eight million in Latin America, though there were indications the spread of the virus was slowing in some countries. During the past week, the daily average of cases in the region fell to 67,173 through Wednesday from 80,512 in the previous seven days, according to a tally by Reuters.

Europe: Western Europe has surpassed the US in new daily infections, re-emerging as a global hotspot after bringing the pandemic under control earlier in the summer. The 27 countries in the European Union plus the UK, Norway, Iceland and Liechtenstein recorded 27,233 new cases on Wednesday, compared with 26,015 for the US.

US: Coronavirus cases in the US increased 0.7% as compared with the same time Wednesday to 6.38 million, according to data collected by Johns Hopkins University and Bloomberg News. The increase was in line with the average daily gain of 0.6% over the past week. Deaths rose by 0.8% to 191,444.

India: India has set another global one-day record for coronavirus infections with 96,551 new cases. The country’s total reported cases are 4,562,414, according to Johns Hopkins data, and deaths stand at 76,271.

Germany: Germany has recorded 1,484 new cases of coronavirus, taking the total of confirmed cases in the country to 2567,850, and 9,342 deaths.

France: France recorded almost 10,000 new Covid-19 infections on Thursday, its highest-ever single-day total, a day before a cabinet meeting that might consider imposing fresh, local lockdowns to curb the spread of the disease.

New Zealand: New Zealand has recorded just one new community case of Covid-19. The person in their 50s is linked to the cluster around the Mt Roskill Evangelical Fellowship group in Auckland.

South Korea: In South Korea, the Korea Center for Disease Control and Prevention reported 176 new cases of Covid-19 as of midnight Thursday, bringing the total number of infections to 21,919, with 350 deaths.

Ukraine: Ukraine registered a record 3,144 new cases of the novel coronavirus in the past 24 hours, the national security council said, up from a previous record of 2,836 registered on September 5.

China: Mainland China reported 15 new coronavirus cases at the end of Thursday, up from seven cases a day earlier. The National Health Commission said in a statement all of the cases were imported infections involving travellers from overseas, marking the 26th straight day of no local infections.

Japan: The Japanese government is planning to have testing centres for coronavirus in nightlife districts across the nation in a bid to prevent flare-ups, Yomiuri reported, without saying who provided the information. Areas to be targeted include bar districts in Tokyo, Osaka, Nagoya, Sapporo and Fukuoka.

UK: Intensive care medics were significantly less likely to have been infected with Covid-19 than cleaners and other healthcare workers in departments deemed a lower risk, according to a study of several British hospitals at the peak of the pandemic.

Vaccine news

Brazil: Brazil is still to decide if it will join the COVAX Facility, a global Covid-19 vaccine allocation plan co-led by the World Health Organization, the acting health minister said on Thursday.

Lockdown updates

Australia: Daniel Andrews, the premier of the state of Victoria, said a curfew imposed to contain the state’s coronavirus outbreak will remain in place as health officials reported 43 new cases and nine deaths in the last 24 hours.

Singapore and Japan: Will begin a reciprocal green lane for business and official travel on 18 September, according to a joint government press statement.

Myanmar: A domestic flight ban came into effect in Myanmar on Friday, with Myanmar National Airlines, Air KBZ, Air Thanlwin and other airlines announcing the suspension of their services, many for at least two weeks.

Colombia: Maria Orozco, Colombia’s transport minister, said international flights to and out of the country will begin gradually, starting on 21 September, following a six-month hiatus to contain the spread of coronavirus.

US: The US is ending its Covid-19 screening of international travellers arriving at airports as airlines seek new ways to more aggressively test for the virus to boost traffic.


9:18 am

Coronavirus company news summary – NHS Scotland contact tracing app launched – Carestream launches personal protection system for frontline workers

KeyOptions has secured the rights to bring Virolens testing units to Australia, Latin America, South East Asia, Turkey and several other countries along with other partners. The Virolens Covid-19 screening test is based on a nano-cellular microscope that uses holographic imaging and artificial intelligence (AI) software technology. It makes use of a non-intrusive saliva swab test to find the presence of the Covid-19 virus within 20 seconds. The Virolens system is claimed to have 99.8% sensitivity and 96.7% specificity.

Scotland’s First Minister Nicola Sturgeon has urged smartphone users across Scotland to download NHS Scotland’s new contact tracing app to help contain the spread of Covid-19. This app is available for download for free through Apple and Google stores. The app, which is supported by a dedicated Protect Scotland website, serves as an additional tool to complement existing person-to-person contact tracing that remains the key aspect of NHS Scotland’s Test and Protect system.

Carestream Health has launched the CARESTREAM Shield, which is designed to protect a user’s eyes, nose and mouth from acutely expelled aerosols of bodily fluid. Carestream has applied its expertise in the development of digital medical imaging systems in developing its new face shield, which will help frontline healthcare workers protect themselves from risky exposure to fluids. It is designed to be used as supplemental protection along with a face mask, goggles and other PPE.

Recently-completed tests at the Colorado State University Biological Safety Level 3 (BSL-3) research laboratorys have found that the surface material of MediFiber‘s Virus Buster face mask can eliminate over 99.99% of SARS-CoV-2 virus particles within 30 minutes. No other face mask material has been able to demonstrate this capability so far. The research found that 99.57% of the virus was neutralised within 10 minutes as compared to the control material, which did not have the antiviral component.

9:13 am

Why US dollar will remain dominant in spite of Covid

11 September

The weakening of the US dollar due to the Covid-19 pandemic, and the new policies proposed by the Federal Reserve, led to speculations that the US dollar is losing its dominance as a global currency.

However, there is ‘push back’ that these speculations are exaggerated because ‘there are no other contenders’ for a reserve currency.

Daniel Lacalle, an economist and author, tweeted on how the US dollar index lost 10% since March and the speculations surrounding its collapse as a reserve currency.

He noted that these speculations are false and that the US dollar index has weakened only relative to the Euro and the Yen.

Lacalle added that the status of the US dollar as a reserve currency is not at risk as there is no other contender.


Read more

10:30 am

International update: Global Covid deaths likely to pass 1 million by October – infections near 28 million

10 September

Global: The global coronavirus death toll has passed 903,000 – just over ten weeks after passing 500,000. If global deaths continued at the current rate, the toll is likely to pass one million before 1 October, ten months after the World Health Organization was first informed of the first cases in Wuhan, China. The number of cases worldwide is nearing 28 million.

Europe: Infections continue to rise rapidly across Europe. France has seen its second-highest one-day case total of the pandemic so far and hospitalisations are at a one-month high, as the Netherlands and Portugal both confirmed their highest daily infections since April.

US: Coronavirus cases in the US increased by 0.2% as compared with the same time Tuesday to 6.33 million, according to data collected by Johns Hopkins University and Bloomberg News. The increase was lower than the average daily gain of 0.6% over the past week. Deaths rose by 0.3% to 189,972.

India: India has reported another record for daily coronavirus cases with the health ministry confirming 95,735 cases over the past 24 hours. Some 1,172 people in India also died from the virus, the ministry said.

Mexico: Mexico reported 4,647 new Covid-19 cases, bringing the total to 647,507, according to data released by the Health Ministry Wednesday night. Cases rose 0.7%, compared with a seven-day average rise of 0.8%.

Spain: Spain’s daily coronavirus infections climbed close to last week’s four-month high, as the country struggles to control fresh outbreaks. There were 4,410 new cases in the past 24 hours, compared with 3,168 recorded Tuesday and taking the total to 543,379, according to Health Ministry data.

New Zealand: New Zealand’s health minister has pleaded with people to stop spreading misinformation about the coronavirus, as the government struggles to contain a mini-cluster centred on an evangelical church in Auckland.

Lockdown updates

UK: Prime Minister Boris Johnson believes a mass testing programme is the UK’s “only hope for avoiding a second national lockdown before a vaccine”, according to leaked official documents.

Japan: Japan plans to lift restrictions on bar and restaurant opening hours. Tokyo is reportedly planning to lift restrictions on opening hours for bars and restaurants, as new coronavirus cases in the city continued on a downward trend.

Australia: Australia’s health minister says the state of Victoria should consider lifting a night-time curfew in Melbourne if it wasn’t imposed for health reasons. The state has been under pressure over the 8pm (10:00 GMT) – 5am (19:00 GMT) curfew since the chief health officer told local radio he hadn’t recommended the policy.

Indonesia: Jakarta governor Anies Baswedan says the Indonesian capital will head back into lockdown as it steps up efforts to tackle what he said was an “emergency – more pressing than the start of the pandemic.”

Economic updates

US: New York City restaurants struggling to stay in business after months of closures imposed in the face of the coronavirus pandemic won a long-awaited approval on Wednesday to resume limited indoor dining.

Indonesia: Indonesia’s benchmark stock index fell 5% after its capital brought back social distancing measures amid a continued rise in the number of coronavirus cases.


9:36 am

Coronavirus company news summary – Print Parts delivers 3D-printed NP swabs to support Covid-19 testing – Vivera Pharmaceuticals announces Covid-19 diagnostic solution

Chembio Diagnostics, a point-of-care diagnostic company, has submitted an application for Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG. This test system detects antibodies to the Spike Receptor Binding Domain in the blood that the body generates in response to a Covid-19 infection.

Print Parts, a US-based additive manufacturing service, has provided over one million nasopharyngeal (NP) swabs for use in NYC Covid-19 test kits. To manufacture these swabs, Print Parts opened a medical manufacturing lab in Manhattan, in collaboration with NYC Health + Hospitals (H+H), the New York City Economic Development Corporation (NYCEDC), Albert Einstein College of Medicine in the Bronx, and Collab, a Brooklyn-based fabrication lab.

Vivera Pharmaceuticals has announced the launch of a partnership with OmeCare, a CLIA-certified global clinical laboratory provider. The Vivera Pharmaceuticals + OmeCare rapid RT-PCR specimen collection kits provide results on for Covid-19 in less than 48 hours.

9:23 am

GlobalData Epidemiologist Report: Global Covid cases pass 27.8 million – deaths exceed 903,000

10 September

Globally, the total confirmed cases of Covid-19 have reached over 27,871,000, with more than 903,000 deaths and 18,780,000 recoveries.

India is the most affected country from Covid-19 with over 90,000 daily new cases and over 1,000 daily new deaths.

The US and Brazil continue to report the high number of daily new cases, but the daily new cases have started to gradually decline in both countries.

In Europe, France and Spain are reporting high number of daily new cases and the testing positivity rate is also rising in these countries.

According to World Health Organization, countries worldwide are now experiencing disruptions in child and maternal health services and vaccinations, as the economic and health resources are diverted to manage Covid-19.

This might reverse the years of progress made in child and maternal health.

Bishal Bhandari, PhD, Senior Epidemiologist at GlobalData  

8:20 am

Climate change adds to Covid driven economic woes

10 September

Wildfires and flooding have become increasingly common due to the effects of climate change.

As these changes increase, they are expected to majorly impact a financial system already under pressure from the Covid-19 pandemic.

Matthew E. Kahn, Bloomberg Distinguished Professor of Economics and Business at Johns Hopkins University, shared an article on how a new report from the US Commodity Futures Trading Commission has highlighted the impact of climate change on financial markets.

The report states that the disruptions caused by climate change can threaten the fundamental conditions that support the country’s financial system.

US President Donald Trump had downplayed the impact of climate change on economic growth.

The new report is a first from a government entity highlighting the damage that climate change can have on financial markets.

The first risk posed by climate change is expected to be rising prices of homes and mortgage default rates due to the wildfires and flooding.

Climate change is also expected to impact agricultural commodity prices, the report added.

In other news, Professor Steve Hanke, economist at Johns Hopkins University, shared an article on more than 10,000 deaths related Covid-19 in Argentina.

Despite having a strict lockdown, the country has not been able to control the spread of the virus.

Read more

2:43 pm

Insilico launches AI-powered Covid-19 research support platform

Hong Kong-based biotech company Insilico Medicine has announced the launch of COVIDomic, a research support platform tailored to the Covid-19 pandemic.

COVIDomic enables scientists to use integrated anonymised patient data with a variety of existing data sets, before applying bioinformatics and artificial intelligence (AI). The platform is intended to help stratify Covid-19 patients more effectively, as well as understanding the disease trajectory and identifying relevant disease pathways and targets.

Insilico Medicine founder and CEO Alex Zhavoronkov said: “COVIDomic is an open access tool to stratify risk and severity from multimodal data sets, including multi-omics data. Insilico Medicine’s AI-driven generative biology approach is a unique offering in the marketplace. We are part of many Covid-19 consortiums and collaborations but COVIDomic is a system that will help scientists and researchers alike to predict the severity of the disease.”

12:02 pm

Low-cost chip detects presence and quantity of Covid-19 antibodies

A device described in a proof-of-concept study published in Biosensors and Bioelectronics uses portable lab-on-a-chip technology to accurately measure the concentration of Covid-19 antibodies present in diluted blood plasma.

Most nations have failed to employ large-scale antibody testing thus far, as the tests can be costly and need to be carried out in a lab by trained operators.

The lab-on-a-chip, which has been developed at the Okinawa Institute of Science and Technology, bypasses this need by combining powerful light-sensing technology with a microfluidic chip. The chip provides results within 30 minutes and is highly sensitive, detecting even the lowest clinically-relevant antibody concentration.

The devices are cheap to manufacture and do not need to be used in a lab or operated by specially trained personnel, increasing the feasibility of nationwide testing.

9:51 am

Coronavirus company news summary – LabCorp launches test for Covid-19, influenza and RSV – QIAGEN launches rapid Covid-19 antigen test

LabCorp has launched the first testing method to test for Covid-19, influenza A/B, and respiratory syncytial virus (RSV) simultaneously. The test is expected to help the doctors regarding the treatment options for the patients. The company has applied to the US Food and Drug Administration (FDA) to provide the combined test via its Pixel by LabCorp at-home test collection kit.

CommonSpirit has opened its Reference Lab, which will increase Covid-19 testing capacity threefold for the 137 hospitals and over 1,000 care sites of the non-profit. The lab is located in Scottsdale, Arizona and will boost the Covid-19 test capacity of the country by 70,000 tests each week.

QIAGEN has planned to launch a rapid portable test to detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes. It will be used to process around 30 swab samples hourly with the help of a small digital detection system. The Access Anti-SARS-CoV-2 Antigen Test is meant for environments with the need for high volume of test results that are fast and reliable.

TEAM Technologies has planned to produce a point-of-care (POC) test to aid organisations that require rapid testing for Covid-19. The company has partnered with Maxim Biomedical to produce the in-vitro diagnostic (IVD) test. Maxim produced the test as part of the NIH Rapid Acceleration of Diagnostics RADxSM initiative which was launched in April.

8:38 am

GlobalData Epidemiologist Report: Global Covid cases pass 27.5 million – deaths near 90,000

9 September

Globally, the total confirmed cases of Covid-19 have reached over 27,575,000, with more than 897,000 deaths and 18,535,000 recoveries.

Worldwide, total confirmed cases and total deaths continue to increase.

The US continues to rank highest in the world with over 6.3 million total confirmed cases.

However, India is currently reporting the highest number of daily new cases in the world, and on current trajectory could overtake the US in the future.

Western European countries have recently seen a rise in daily new cases that seems to have coincided with the reopening of their economies.

England will ban the social gathering of more than six people from September 14. This strict measure will be undertaken as cases have started to rise alarmingly in recent days.

This restriction is for private gatherings and will not apply to workplaces and schools.

Bishal Bhandari, PhD, Senior Epidemiologist at GlobalData  

7:58 am

How stimulus wrangles could deepen US recession

9 September

The Democrats and Republicans are yet to reach a consensus on further stimulus package for the US economy.

The delay in releasing stimulus into the economy could worsen the unemployment rate and force states to increase spending cuts.

Adam Posen, president of Peterson Institute for International Economics, shared an article on how additional stimulus is essential for the US economy to recover from the impact of the Covid-19 pandemic.

The Democrats propose a stimulus package of $3.4tn, while the Republicans have proposed $1tn.

Lack of consensus on the stimulus may result in spending cuts by states causing a deeper recession, loss of between 4% and 5% of GDP and an increase in unemployment by 4% to 5%.

Black families and minorities are expected to be worst affected.

In addition, Mark Weisbrot, co-director of Center for Economic & Policy Research, shared an article on how states in the US are in a financial crisis.

Read more

10:20 am

International update: Covid deaths exceed 892,000 – infection rates rise in Europe

8 September

Global: The global coronavirus death toll has passed another sombre milestone, exceeding 892,000 as confirmed by researchers at Johns Hopkins University. The true death toll is likely to be higher, due to differing testing rates and definitions, time lags and suspected underreporting in some countries. Global Covid cases exceed 27.3 million.

India: India has reported the most deaths from coronavirus in a month. The health ministry says 1,133 people died of Covid-19 in the last 24 hours, lifting the total death toll to 72,775. Infections have passed 4.2 million.

Spain: Spain has become the first western European country to record more than half a million Covid-19 cases, logging a total of 525,549 infections.

France: A leading epidemiologist in France has warned that if the number of Covid-19 cases continues to rise at the current rate, the country could face a “critical situation” in several regions in December.

UK: England’s deputy chief medical officer, Jonathan Van-Tam, said the rise in the number of coronavirus cases was of great concern adding: “We have got to start taking this very seriously again”.

Vaccine news

US: An unsubstantiated claim two weeks ago by President Trump – that the “deep state” was slowing approval of a Covid-19 vaccine – has set off an effort by government officials and private industry to ensure the White House doesn’t interfere with a methodical, careful scientific process.

Europe: The European Commission said it is close to reaching an agreement with BioNTech SE on the supply of any successful Covid-19 vaccine.

Mexico: Mexico will participate in the Covax facility led by the World Health Organization to obtain vaccines via the global program to equitably distribute Covid-19 vaccines, according to a Foreign Ministry statement.

Indonesia: Indonesian President Joko Widodo formed a national team to accelerate the development of Covid-19 vaccine in a rule signed on 3 September, according to the Cabinet Secretariat.

Japan: Japan has approved the use $6.3 billion from its emergency budget to secure coronavirus vaccines.

Lockdown updates

Hong Kong: Hong Kong’s government will further ease virus-related restrictions and allow restaurants to seat four people per table instead of the current limit of two, Hong Kong Economic Times reported, citing unidentified people.

Japan: The Japanese government is considering eliminating the cap of 5,000 people it has on event sizes as soon as Sept. 19 after determining that the coronavirus outbreak is easing, Kyodo reported, citing an unidentified official.

Singapore: About 13,000 workers who haven’t undergone routine coronavirus testing as of Sept. 6 will be banned from returning to work to ensure the safety of other workers, the Singapore government said in a joint statement.

Economic updates

Japan: Japan’s economy shrank slightly more than initially thought in the April-June quarter, official data released Tuesday showed, deepening a contraction that was already the worst in the nation’s modern history.

9:17 am

GlobalData Epidemiologist Report: Global Covid cases pass 27.3 million – more than 892,000 deaths

8 September

Globally, the total confirmed cases of Covid-19 have reached over 27,342,000, with over 892,000 deaths and 18,338,000 recoveries.

Worldwide, total confirmed cases and total deaths continue to rise.

European countries such as Spain and France have reported alarming increase in daily new cases in recent days.

However, The US, India, and Brazil are still the primary driver of these increases.

This is due to the sheer magnitude of total confirmed cases that rank them first, second, and third highest in the world, respectively.

Studies have reported the long-term effect of Covid-19.

In the UK, estimated 60,000 people had symptoms for more than three months.

Long term symptoms ranged from mild to debilitating requiring medical support and rehabilitation.

Bishal Bhandari, PhD, Senior Epidemiologist at GlobalData

9:09 am

Dollar facing pressure from the Chinese yuan – Covid puts brake on Indian economy

8 September

The US Federal Reserve’s new policies drafted to increase inflation are aimed to improve the country’s economy. However, these policies may weaken the dollar.

Peter Morici, an economist and professor at the University of Maryland, shared an article on how the Federal Reserve’s policies to increase inflation may threaten the dollar’s dominance as a global currency.

The article noted that although the Federal Reserve has announced the policy change, the central bank’s policy making powers have diminished over the years due to the globalisation of US securities markets and dollar’s dominance in global commerce.

The Federal Reserve needs to finance federal deficits and drive inflation by printing money to ensure the dollar’s dominance as the Chinese Yuan is fast emerging as a rival to the currency.

Meanwhile, India’s economic prospects look bleak, as the Covid-19 pandemic is affecting an economy that was already in slowdown.

Read more

9:09 am

Coronavirus company news summary – BillionToOne secures EUA for SARS-CoV-2 diagnostic test – India’s Union Health Ministry updates Covid-19 testing strategy

Diagnostics company BillionToOne has secured Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 diagnostic test, which is designed to remove the costly and time-consuming step of RNA extraction. Compared with most other molecular assays that depend on RNA extraction and qRT-PCR, the firm’s qSanger-COVID-19 assay makes use of a different set of instruments and chemicals from existing tests, which in turn allows labs to tap a new, unused capacity for the detection of Covid-19 causing SARS-CoV-2.

Swiss company ender diagnostics has announced collaboration with Swiss International Air Lines (SWISS), a subsidiary of Lufthansa, to test all long-haul cabin crew members for SARS-CoV-2. Testing the long-haul crew members of SWISS before departure will help to further boost detection of Covid-19 infection and boost the safety of people travelling.

The Union Health Ministry of India has updated its advisory on testing strategy for Covid-19. It has introduced on-demand testing without the need for a prescription. However, it has allowed the state health authorities to alter the modules according to their requirements.

12:57 pm

International update: Global Covid cases pass 27.1 million – India second most infected with 4.2 million

7 September

Global: Global Covid-19 deaths have passed 889,000 with more than 27.1 million cases according to the Johns Hopkins University tracker.

US: Coronavirus cases are rising in 22 of the 50 US states, a Reuters analysis has found. Three weeks ago, cases were only rising in three states – Hawaii, Illinois and South Dakota.

“Pandemic fatigue” is an additional risk as the US heads into the fall and winter, when infectious diseases traditionally spread more readily, former Food and Drug Administration head Scott Gottlieb said.

India: India has recorded a global one-day record of more than 90,000 positive coronavirus cases, taking the country past Brazil as the second most infected country in the world, with 4.2 million confirmed cases.

UK: Nearly 3,000 more people in the UK tested have positive for Covid-19, with 2,988 new cases reported on Sunday – a sharp increase from 1,813, and the highest number of new cases since 23 May.

Ireland: Ireland recorded another 138 new cases, with about half the new infections in Dublin, according to health authorities. That pushed the weekend total to almost 370, the worst weekend figure since early May.

France: France reported 7,071 coronavirus cases in the last 24 hours, showing the pandemic is continuing to progress at a “worrying” pace, the health ministry said in a statement Sunday.

Italy: Italy reported 1,297 new coronavirus cases on Sunday. This is the smallest increase in five days amid lower than usual testing at the end of the week.

Philippines: Researchers from the University of the Philippines said that the spread of Covid-19 in the country is slowing down, citing the rate of reproduction in major cities

Hong Kong: An estimated 1.13 million residents of Hong Kong have signed up for free coronavirus testing in the semi-autonomous Chinese city.

Syria: A United Nations official has said that more than 200 of its staff in Syria have contracted coronavirus.

Vaccine news

Australia: Australia on Monday said it will receive the first batches of a potential Covid-19 vaccine in January 2021, as the country’s virus hotspot said the number of new daily infections has fallen to a 10-week low.

Greece: Nearly half of Greeks (44%) would refuse to be vaccinated against the coronavirus, according to a poll of 1,000 respondents published on Sunday.

Economic updates

Australia: Australia’s government warned of mounting economic pain as Victoria state announced only a gradual easing of its coronavirus lockdown that will see retail, hospitality, tourism and entertainment under tight controls across Melbourne until at least the end of October.


9:08 am

Coronavirus company news summary – GenePath receives approval to sell PCR test in India – Maxim to sell three million Covid-19 antigen tests

GenePath Diagnostics, a company based in Pune, India, has received approval to manufacture and sell its Covid-19 RT-PCR test kit from Central Drugs Standard Control Organisation (CDSCO). Times of India has reported that GenePath is the second company from Pune to receive approval to manufacture Covid-19 PCR test kits.

Novacyt has launched a CE approved Covid-19 PCR two gene target test. This test offers an additional option to the company’s single gene test, addressing the needs of a number of countries which require a two gene target testing approach for Covid-19.

Roche has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 & Influenza A/B Test. The test will be used on the cobas 6800/8800 Systems. It is expected to detect and differentiate SARS-CoV-2, Influenza A and Influenza B simultaneously in suspected patients, and will be available in countries which accept the CE Mark.

Maxim Biomedical has planned to manufacture and sell around three million Maxim SARS-CoV-2 Rapid Antigen Diagnostic Tests by the end of this year. The company added that the patent is pending for the test. Maxim developed the test in partnership with National Institutes of Health (NIH) via the Rapid Acceleration of Diagnostics (RADxSM) initiative.

8:24 am

How remote working can improve wellbeing and help control Covid-19

7 September

Many companies across the world have opted for remote working operations to safeguard their business and employees.

Remote working, however, has an indirect impact on the businesses that are dependent on employees for their business.

Julian Jessop, an independent economist and writer, shared an article, how working from home (WFH) can cost £15bn a year for the UK, according to PricewaterhouseCoopers.

WFH is expected to severely impact coffee shops, security guards and support jobs causing a GDP loss of 1%.

Various businesses who are reliant on office goers for their business have already started to feel the impact of the pandemic induced remote working.

Pret A Manger, for example, operates primarily near to office blocks and has announced its plans to cut 3,000 jobs. Further, the company is planning to expand into suburbs to sustain its business.

Jessop opined that the impact of WFH on GDP, is a small price to pay compared to the improvements it will provide in wellbeing such as less commuting.

Remote working can also help in controlling the pandemic, Jessop noted.

Read more

2:21 pm

GlobalData Epidemiologist Report: Global Covid-19 cases pass 26.3 million – deaths exceed 869,000

4 September

Globally, the total confirmed cases of Covid-19 have reached over 26,337,000, with more than 869,000 deaths and 17,545,000 recoveries as daily confirmed cases continue to increase.

The US continues to rank highest in the world with over 6.1 million total confirmed cases, followed by Brazil with over 4 million total confirmed cases, and India with over 3.9 million total confirmed cases.

Additionally, the US continues to report a high death toll, contributing approximately 22% to global deaths, followed by India with 14%, and Brazil with 8%.

In Thailand, just one day after marking a significant milestone of 100 days with no local transmission of the coronavirus, a new case was identified.

This case had tested positive after arriving at a correctional center, and after a detailed case history, was determined to be locally transmitted.

Natasha Karim, MPH, Managing Epidemiologist at GlobalData 

11:01 am

International update: Global Covid cases pass 26.3 million – US gears up for early vaccine roll out

4 September

Global: Global Covid-19 deaths are nearing 869,000 with more than 26.3 million cases according to the Johns Hopkins University tracker.

US: Coronavirus cases in the US increased by 0.7% as compared with the same time Wednesday to 6.13 million, according to data collected by Johns Hopkins University and Bloomberg News. The increase matched the average daily gain over the past week. Deaths rose by 0.8% to 186,293.

Brazil: Brazil has recorded more than four million confirmed cases of coronavirus, with 43,773 new cases and 834 deaths from the disease caused by the virus reported in the past 24 hours, the health ministry said on Thursday.

India: India reported a daily jump of 83,341 coronavirus infections, taking its tally to 3.94 million, health ministry data showed.

Ukraine: Ukraine registered a record 2,723 cases of the new coronavirus in the past 24 hours, the national security council said on Friday, up from a previous record of 2,495 cases.

Australia: The state of Victoria has confirmed 81 new coronavirus cases and nine deaths in the last 24 hours. It also added 50 deaths from people who passed away in aged care facilities in July and August.

France: France registered more than 7,000 new coronavirus infections over 24 hours for the second time in two days, the health ministry said on Thursday, while hospitalisations for the virus also rose again.

Mexico: Mexico leads the world in coronavirus deaths among its healthcare workers, Amnesty International has said in a new report. The report said Mexico has reported 1,320 confirmed deaths among health workers from Covid-19 so far, surpassing the United States at 1,077, the United Kingdom at 649, and Brazil at 634.

Thailand: Thailand has reported its first locally transmitted coronavirus case in 100 days, after a prison inmate was confirmed to have Covid-19. Dozens of contacts are now being tested, including his family members, people he met in court and other inmates. He had been arrested for drug offences on 26 August.

South Korea: Doctors have agreed to end a two-week strike, which has hindered efforts to curb a new wave of coronavirus infections, Prime Minister Chung Sye-kyun said on Friday, after overnight talks over the government’s medical reform plans, Reuters reports.

Hong Kong: Hong Kong’s new universal testing blitz has identified six infections, initial results showed a sign the campaign could uncover hidden infections despite limited participation.

Vaccine news

US: Authorization of a Covid-19 vaccine by 1 November when US health officials have told states to be prepared to distribute shots is “extremely unlikely but not impossible,” Moncef Slaoui, chief scientific adviser to Operation Warp Speed told NPR’s All Things Considered on Thursday.

Federal public health officials in the US have asked their state counterparts to prepare to distribute a potential coronavirus vaccine to high-risk individuals as early as late October.

Lockdown updates

Israel: Israel announced Thursday a new lockdown affecting 30 areas as it grapples with one of the world’s highest detected per capita infection rates and a death toll nearing 1,000, AFP reports.

New Zealand: Prime Minister Jacinda Ardern said on Friday that the country’s current restrictions to beat the spread of the coronavirus pandemic would be retained until mid-September. The largest city, Auckland, will remain on alert level 2.5, while the rest of the country will be on alert level 2.0, Ardern told a news conference. The settings would be reviewed on 14 September, she said.

UK: English tourists in Greece and Portugal have been spared the cost and chaos of rushing back to the UK after the British government defied expectations and maintained quarantine-free travel from both countries for the time being.

Australia: Health minister Greg Hunt extended restrictions on international travel and the entry of cruise ships until 17 December to protect the country against the spread of the coronavirus.

Economic updates

Turkey: Turkey has extended by two months a layoff ban it introduced to combat the economic impact of the coronavirus pandemic, Reuters reports.

Australia: Prime Minister Scott Morrison announced that most state and territory leaders in Australia were recommitted to opening up the country’s economy by December. But he didn’t secure an immediate agreement to lift the border restrictions hampering the recovery.


9:34 am

Coronavirus company news summary – FDA aproves BreviTest’s Covid-19 IgG antibody test – Fujifilm Sonosite receives 510(k) approval for POCUS portfolio to support Covid-19 patients

DetectaChem has announced that its MobileDetect Bio (MD-Bio) BCC19 Covid-19 test kit has received Emergency Use Authorisation from the US Food and Drug Administration (FDA). The BCC19 test kit makes use of portable laboratory-grade diagnostic technology that can operate up to 96 tests in each device in just 30 minutes. The test detects nucleic acids from the 2019-nCoV virus to determine positive or negative results and then makes use of the free MobileDetect App for Apple and Android platforms to produce result reports with time, date, images, patient info, GPS mapping and more.

BreviTest Technologies announced that the US FDA has allowed the commercial distribution of its IgG antibody test. The BreviTest SARS-CoV-2 IgG Test identifies the presence of SARS-CoV-2 specific IgG antibodies in plasma or serum using only 3μl of sample. Results are produced in ten minutes.

OraSure Technologies has announced that its ORAcollect·RNA (OR-100) collection device has been included along with other devices in the US FDA EUA granted to Los Angeles-based molecular genetics company MiraDx. This is the fifth EUA to include a collection device from the company’s DNA Genotek subsidiary.

Fujifilm Sonosite, a provider of point-of-care ultrasound (POCUS) solutions, has received 510(k) approval from the US FDA for its complete POCUS portfolio to support healthcare providers in carrying out lung and cardiac imaging in patients suffering with Covid-19. Meanwhile, Fujifilm Sonosite has also released a comprehensive user guide intended to aid healthcare professionals on how to best use POCUS technology to correctly interpret ultrasound images to identify the most typical Covid-19 findings relating to lung and cardiac conditions.

9:04 am

How healthcare investment can boost jobs

4 September

The Covid-19 pandemic has highlighted the importance of having a robust healthcare system for every country across the world.

Increasing healthcare investment can not only create new jobs amid the pandemic but also create a more productive population.

Amanda Larsson, campaigner with Greenpeace NZ, tweeted on how investment in care in the UK can create 2.7 times new jobs that are equivalent to investment in construction.

Investment in care can also create 6.3 times as many jobs for women and 10% more for men.

The tweet was based on report from the Women’s Budget Group, an independent think tank, on how investment in care can stimulate employment and reduce gender employment gap.

Developing a better care system will require a major proportion of the population to be employed in the healthcare sector thereby increasing the overall employment rate.

Meanwhile, the Washington Post highlights a looming unemployment crisis for the US.

Read more

2:02 pm

GlobalData Epidemiologist Report: Global Covid cases pass 26 million – Brazil and India near 4 million

3 September

Globally, the total confirmed cases of Covid-19 have reached over 26,062,000, with over 863,000 deaths and 17,315,000 recoveries.

In the majority of countries in the European, African, Eastern Mediterranean, and Western Pacific regions, daily confirmed cases continue to decrease, while the Americas and South-East Asia continue to see a rise in daily cases.

The US, Brazil, and India primarily drive these increases due to the sheer magnitude of total confirmed cases that rank them first, second, and third highest in the world, respectively.

Brazil and India are both now approaching 4 million cases.

Meanwhile, Israel set a record high with over 3,000 daily confirmed cases reported today.

This marks the country’s biggest one-day jump, and brings the total number of confirmed cases to nearly 123,000.

Natasha Karim, MPH, Managing Epidemiologist at GlobalData

9:48 am

International update: Global Covid cases pass 26 million – more than 863,000 deaths

3 September

Global: Global Covid-19 deaths passed 863,000 with more than 26 million cases, according to the Johns Hopkins University tracker. The highest death toll is in the US, where 185,707 people have died.

Testing people twice for the coronavirus, with a nasal swab followed by an antibody finger prick test, would catch most of those people who fail to get the right Covid-19 diagnosis, researchers believe.

Treating critically ill Covid-19 patients with corticosteroid drugs reduces the risk of death by 20%, an analysis of seven international trials has found, prompting the World Health Organization to update its advice on treatment.

US: The Trump administration is planning to cut its membership dues to the World Health Organization, in a legally controversial move that will be challenged by Congress.

India: India reported a daily jump of 83,883 coronavirus infections on Thursday, taking its tally to 3.85 million, just 100,000 behind Brazil, the world’s second most affected nation, health ministry data showed. According to Johns Hopkins, this is the second-highest one day total ever reported, with India breaking the world record on 26 August with more than 85,000 cases.

Australia:  Victoria state on Thursday reported a triple-digit rise in new Covid-19 infections for the first time in four days, denting optimism that the second wave of cases has been contained. The state said that 113 new cases were detected in the past 24 hours, an increase on the 90 infections reported on Wednesday.

Brazil: Brazil’s Covid-19 death toll appears to be easing for the first time since May, a sign the Latin American country could be descending from a long infection plateau that has seen it suffer the world’s second-worst outbreak after the United States.

Turkey: Turkey is seeing a second peak of its coronavirus outbreak due to “carelessness” at weddings and other social gatherings, its health minister has said, amid a rapid rise in the number of daily cases and deaths.

France: Daily new Covid-19 infections in France neared an all-time high on Wednesday and the number of people hospitalised in intensive care units for the disease grew at its fastest pace in almost two months.

France reported 7,017 coronavirus cases in the past 24 hours, raising the seven-day average increase to the highest since the outbreak began.

Germany: The number of confirmed coronavirus cases in Germany increased by 1,311 to 246,166, data from the Robert Koch Institute (RKI) for infectious diseases showed on Thursday.

South Korea: South Korea has reported 195 new cases of coronavirus. That’s the lowest since August 17, according to Yonhap News Agency. While there are signs the spike that began last month is easing – thanks to stricter distancing rules – a record number of patients are in critical condition.

Lockdown updates

China: An Air China flight from Phnom Penh was the first international flight to land in Beijing after direct flights from eight countries were allowed to resume. Passengers must have tested negative for Covid-19 before they board and complete a 14-day government-run quarantine on arrival.

UK: The UK government is “anxiously monitoring” increasing hospital admissions in France and Spain, the Financial Times reported, citing unidentified colleagues of Health Secretary Matt Hancock.

9:32 am

Coronavirus company news summary – Pinnacle IVD develops 15-minute antigen test – Todos Medical and Pangea enter into test and trace partnership

Pinnacle IVD has announced the addition of the CovID Rapid Antigen Detection Test (RAD) to its current diagnostic test product line, which includes the Pinnacle CovID NEO IgG/IgM Antibody Test (NEO) and the second generation FIT Colon Cancer Test. The RAD is claimed to be one of the first point of care antigen tests that does not need additional laboratory equipment and provides accurate results in just 15 minutes. The firm has notified the US FDA through pre EUA format that it plans to submit an emergency use authorisation (EUA) within 10 days. 

BASE10 Genetics has announced the results of an independent study that found 95% sensitivity and 100% specificity for SARS-Co-V-2 IgG antibodies using AccuFind COVID19 IgG test by DNA Link. This study was carried out at John Hopkins University. BASE10 provides a Covid-19 Tracking and Recovery Program that helps employers in introducing testing and monitoring strategies for Covid-19. The firm has been working to include antibody testing to monitor the full life cycle of SAR-Co-V-2.

Todos Medical, an in vitro diagnostics company, has entered into a Covid-19 testing and tracing partnership with Israel-based Pangea. Todos will be the preferred supplier of Covid-19 testing products for Pangea’s suite of offerings aimed at delivering contact tracing and ‘Covid testing passport’ services in Israel and some African countries. Todos will also be able to integrate and tailor Pangea’s technology offering into its services package in the US, Canada and Mexico in order to deliver a full solution for Covid-19 testing and contact tracing in a HIPAA compliant, ‘opt-in’ privacy tailored manner.

Biohit Healthcare‘s antibody and antigen tests for Covid-19 have received approval from Brazil’s Ministry of Health. The firm’s Sars-CoV-2 IgM/IgG antibody test and SARS-CoV-2 Antigen quantitative assay kit are now included in the select group of Covid-19 tests of allowed manufacturers of goods in Brazil.