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October 14, 2020

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

By Chris Lo

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.

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