June’s top stories: Bowel cancer home testing kit launched, Medtronic to acquire HeartWare

Belgium-based molecular diagnostics company Biocartis has secured Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its Idylla Ebola Virus Triage Test (Idylla EBOV Test) to detect the Ebola Zaire virus in patients.


Bowel

UK introduces new home testing kit for early bowel cancer detection

The UK Department of Health has announced the introduction of a new bowel cancer home testing kit across England.

The introduction of the new kit, which could potentially save hundreds of lives, has been confirmed by UK Public Health Minister Jane Ellison.

A successful pilot programme involving 40,000 people had prompted the UK National Screening Committee to recommend the test to be introduced across the nation.

Medtronic to acquire HeartWare for $1.1bn

Ireland-based medical device company Medtronic has entered into an agreement to acquire medical-technology company HeartWare for approximately $1.1bn.

Under the agreement, Medtronic will float a tender for all outstanding shares of HeartWare common stock, each of which will be valued at $58 in cash, which has received a nod of approval from the board of directors of both of the companies.

Subject to the customary closing conditions, the transaction is expected to be completed at the end of this year.

Biocartis secures FDA emergency use authorisation for Idylla Ebola Virus Triage test

Idylla

Belgium-based molecular diagnostics company Biocartis secured Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its Idylla Ebola Virus Triage Test (Idylla EBOV Test) to detect the Ebola Zaire virus in patients.

Developed in collaboration with Biocartis, Janssen Diagnostics (a division of Janssen Pharmaceutica NV) and the Belgium Institute of Tropical Medicine, the Idylla EBOV Test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test, which gives results within 100 minutes on a single cartridge, compatible with the Biocartis Idylla platform.

The Biocartis Idylla platform is a fully automated, sample-to-result, real-time RT-PCR system designed for a quick implementation irrespective of the infrastructure of nations.

Zimmer Biomet to acquire LDR designs for $1bn

US-based medical device company Zimmer Biomet received approval from its board of directors for a definitive agreement to acquire France-based LDR designs for an approximately value of $1bn.

Under the definitive agreement, Zimmer Biomet is now authorised to float a tender offering to acquire LDR's outstanding shares, each valued at $37 in an all-cash transaction.

Subject to customary closing conditions, the potential transaction is expected to be completed at the end of this year.

Hologic secures FDA emergency use authorisation for Aptima Zika Virus assay

Zika

US-based medical device company Hologic received emergency use authorisation from the US Food and Drug Administration (FDA) for its Aptima Zika Virus assay to detect Zika virus.

The Aptima Zika Virus assay is a transcription-mediated amplification test designed for a qualitative detection of RNA from the Zika virus by testing human serum and plasma specimens.

It is based on the Hologic Panther system, which is an integrated platform that fully automates all the every stage of nucleic acid amplification testing.

Ortho gets CE mark for VITROS HIV Combo Test to detect HIV-1 acute infection

US-based medical device company Ortho Clinical Diagnostics (Ortho) secured the CE mark approval for its VITROS HIV Combo Test to detect HIV-1 acute infection.

The VITROS HIV Combo test kit is the company's fourth generation assay which can detect both HIV-1 and HIV-2 antibodies, as well as the p24 antigen facilitating an early detection of HIV-1 acute infection.

Ortho CEO Robert Yates said: "Ortho is committed to expanding its assay menu and is investing in a pipeline that significantly improves laboratory outcomes for our customers.

Global Kinetics and NPF begin clinical trial of PKG System for Parkinson's Disease

Parkinson

Global Kinetics and National Parkinson Foundation (NPF) initiated collaborative clinical research to determine the effect of continuous objective measurement of movement in patients with Parkinson's disease using the Personal KinetiGraph (PKG) movement recording system.

The PKG System, developed by Global Kinetics, precisely and objectively tracks changes in mobility in patients with diseases andconditions affecting motor skills.

The clinical research project will be a multi-centre, randomised controlled trial, which will enrol more than 400 Parkinson's patients, conducted as part of the NPF Parkinson's Outcomes Project Registry Study which began in 2009.

Terumo to acquire Sequent Medical for $280m

Japanese firm Terumo entered an agreement to acquire US-based Sequent Medical for $280m.

Subject to regulatory approval, the potential acquisition is expected to be completed in July or August.

The $280m will be paid after completion of the acquisition, while an additional $100m will be paid based on specific development or commercial milestone achievements.

Spectratech develops OEG-16H to communicate with comatose patients

Comatose

Japan-based medical technology company Spectratech developed its fNIRS device, OEG-16H, an encephalography mechanism to measure changes in hemoglobin and apparent arterial oxygen saturation in the frontal lobe of comatose patients.

The device is based on Spectratech-developed Ultrahigh SNR technology which can display ultra-weak pulse waves and allow users the ability to perform a multi-channel brain localisation analysis.

Its index of Apparent SpO2 (apparent arterial oxygen saturation) facilitates a better understanding of how to influence the actions from cerebral circulation / metabolism to brain function by the Ultrahigh SNR technology.

BD introduces Vacutainer UltraTouch Push Button Blood Collection Set in UK

US-based medical technology company Becton, Dickinson and Company (BD) introduced the BD Vacutainer UltraTouch Push Button Blood Collection Set in the UK.

It is a new safety blood collection set, which is based on the company's patented PentaPoint Comfort 5-bevel needle technology that helps improve patient experience during the blood collection procedure.

The technology has earlier been used in the BD Pen insulin injection needles and exhibited reduced risk of pain caused due to injection by creating a flatter, thinner surface for a convenient skin penetration.