Bio-Rad ddPCR COVID-19 Assay Secures FDA Emergency Use Authorization

Bio-Rad Laboratories, Inc.’s (Hercules, CA, USA) SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit which runs on its QX200 and QXDx ddPCR systems has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

The SARS-CoV-2 ddPCR test represents the latest addition to Bio-Rad’s product offerings related to COVID-19 and is the second EUA that has been granted to the company for COVID-19. Last week, Bio-Rad had secured EUA for its serology test to detect antibodies to the virus.

The high sensitivity of Bio-Rad’s single-well SARS-CoV-2 ddPCR 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 and informing them if they are negative for the virus. It also provides clinicians with a high degree of sensitivity that can significantly improve the accuracy of reported results. Thousands of hospitals and molecular testing labs in the US and around the world have installed Bio-Rad’s QX200 and QXDx ddPCR systems and have the capacity to perform SARS-CoV-2 ddPCR testing.

“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 US.”