Business & Finance
Bio-Rad Receives FDA Emergency Use Authorization for Droplet Digital PCR SARS-CoV-2 Test Kit
4 May 2020 - - US-based life science research and clinical diagnostic products developer Bio-Rad Laboratories Inc's (NYSE: BI) SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been granted Emergency Use Authorization by the US Food and Drug Administration, the company said.

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.

Thousands of hospitals and molecular testing labs in the US 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.

BIO-RAD, DROPLET DIGITAL PCR, and ddPCR, are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions.

Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,100 employees worldwide. Bio-Rad had revenues exceeding USD 2.3bn in 2019.

The SARS-CoV-2 ddPCR Test Kit has been authorized for emergency use by FDA under an EUA as described in this document.

This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the SARS-CoV-2 ddPCR Test Kit under Section 564(b) (1) of the Federal Food, Drug, and Cosmetic Act, 21 USC. § 360bbb- 3(b) (1), unless the authorization is terminated or revoked sooner.