Bio-Rad receives FDA emergency use authorization for droplet digital PCR SARS-CoV-2 test kit

Bio-Rad Laboratories Inc., a global leader of life science research and clinical diagnostic products, has 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). 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 early stage," said Simon May, Senior Vice President of Bio-Rad’s Digital Biology Group. "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 U.S.," he said.

Thousands of hospitals and molecular testing labs in the U.S. and around the world have Bio-Rad’s QX200 and QXDx ddPCR systems installed and have the capacity to perform SARS-CoV-2 ddPCR testing. The SARS-CoV-2 ddPCR test represents the latest addition to Bio-Rad’s product offerings related to COVID-19. This is the second EUA Bio-Rad has been granted for COVID-19. Last week, the company received an EUA for a serology test to detect antibodies to the virus.

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