Bio-Rad COVID-19 test cleared in U.S.

By LabPulse.com staff writers

May 6, 2020 -- Bio-Rad Laboratories has garnered emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its droplet digital polymerase chain reaction (ddPCR) test for SARS-CoV-2.

The test runs on the company's QX200 system. Bio-Rad believes that its ddPCR technology is more sensitive than conventional real-time quantitative PCR (qPCR) technology for detecting SARS-CoV-2, the virus that causes COVID-19. Whereas qPCR tests measure viral load, ddPCR directly counts virus particles, which brings more certainty to the diagnosis, Bio-Rad explained.

Bio-Rad Laboratories
Bio-Rad Laboratories' ddPCR test for SARS-CoV-2 runs on the company's QX200 system. Image courtesy of Bio-Rad.

Bio-Rad also markets a SARS-CoV-2 test for immunoglobulin G, A and M antibodies (IgG/IgM/IgA), which has an EUA from the agency.

Bio-Rad launches COVID-19 antibody test kit
Bio-Rad Laboratories has begun shipping its SARS-CoV-2 Total Ab blood-based immunoassay kit.
Biodesix, Bio-Rad file for emergency authorization of coronavirus test
Biodesix and Bio-Rad Laboratories have submitted an emergency use authorization application with the U.S. Food and Drug Administration for their Droplet...
Bio-Rad debuts guide to improve access to COVID-19 tests
Bio-Rad Laboratories has launched a standard for SARS-CoV-2 to help labs validate assays and speed up access to testing for COVID-19 novel coronavirus...
Bio-Rad taps new head of clinical diagnostics
Bio-Rad Laboratories has tapped diagnostics industry veteran Dara Grantham Wright as president of its Clinical Diagnostics Group, replacing John Hertia,...
Bio-Rad launches QX One PCR system at AMP 2019
Bio-Rad Laboratories announced the release of its QX One Droplet Digital polymerase chain reaction (ddPCR) system at the Association for Molecular Pathology...

Copyright © 2020 LabPulse.com

Last Updated ls 5/5/2020 4:22:47 PM