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May 5, 2020updated 02 Nov 2021 8:51am

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.


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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.

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.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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