Bio-Rad secures FDA emergency use authorisation for Covid-19 test kit

Bio-Rad Laboratories has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit that detects Covid-19 disease.

Bio-Rad Laboratories earlier launched a blood-based immunoassay kit that helps diagnose Covid-19 by analysing the immune response against SARS-CoV-2 virus. Credit: Governor Tom Wolf.

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The test utilises the company’s QX200 and QXDx ddPCR systems, which are in use across thousands of hospitals and molecular testing labs in the US and the rest of the world.

Due to its high sensitivity, the test is claimed to be well-suited for screening upper respiratory samples in patients with a low viral load as compared to other quantitative PCR tests.

In addition, it can play an important role in surveillance by detecting minimal residual disease in people recovering from Covid-19. This will help to inform the patients if they are negative for the virus.

Bio-Rad Digital Biology Group senior vice-president Simon May said: “We are pleased to receive emergency use authorisation for our SARS-CoV-2 ddPCR test that offers high sensitivity in detecting infection of Covid-19 at an early stage.

“We believe the test will be a powerful complement to current diagnostics, helping clinicians and public health officials accurately identify infected individuals in a timely manner. With the EUA, our test is now available to clinical labs in the US.”

The SARS-CoV-2 ddPCR test is the new addition to Bio-Rad’s product offerings related to Covid-19. Earlier, the company launched a blood-based immunoassay kit that detects antibodies to the SARS-CoV-2 virus.

The test, which helps to diagnose Covid-19 by analysing the immune response against SARS-CoV-2, was granted EUA by the US FDA last week.