Bio-Rad Receives FDA Emergency Use Authorization for Droplet Digital PCR SARS-CoV-2 Test Kit

Bio-Rad Laboratories Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).


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The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad's QX200 and QXDx ddPCR systems.

The high sensitivity of the test makes it well suited to screening upper respiratory samples in patients with a low viral load, including individuals in the early stages of infection as compared to classical quantitative PCR tests. The test can also play an important role in surveillance by detecting minimal residual disease in people recovering from COVID-19 informing them if they are negative for the virus. Bio-Rad’s single-well SARS CoV-2 ddPCR test provides clinicians with a high degree of sensitivity that can significantly improve the accuracy of reported results.

According to the World Health Organization, regular, accurate testing of COVID-19 is a key component in the fight against the global pandemic.

"We are pleased to receive Emergency Use Authorization for our SARS-CoV-2 ddPCR test that offers high sensitivity in detecting infection of COVID-19 at an ...

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