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September 21, 2020

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

By Chloe Kent

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.

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