BioRad teams with Biodesix on COVID-19 total antibody test

By LabPulse.com staff writers

May 20, 2020 -- Bio-Rad Laboratories and lung cancer diagnostics firm Biodesix have joined forces to launch a serology test for detecting COVID-19 antibodies.

The Platelia SARS-CoV-2 Total Ab test received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) in late April. In clinical evaluation, the test yielded more than 99% specificity and 98% diagnostic sensitivity eight days after the onset of symptoms, according to the firms.

Platerial SARS-CoV-2 Total Ab requires a blood sample. After receipt at the CLIA-certified laboratory in De Soto, KS, results will be delivered in 24 hours, Biodesix said. Biodesix can currently process 14,000 tests each day, according to the vendor.

In other Bio-Rad news, the company said that its CFX96 Dx real-time polymerase chain reaction (PCR) system has been listed with the FDA for IVD testing, enabling assay developers and testing laboratories in the U.S. to access the system. It has already been used by laboratories outside the U.S., according to the firm.

Bio-Rad COVID-19 test cleared in U.S.
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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...
Biodesix expands lung cancer blood testing portfolio
Lung cancer diagnostics firm Biodesix has introduced Nodify CDT, a blood-based test kit designed to help identify patients with lung nodules that are...

Copyright © 2020 LabPulse.com

Last Updated ls 5/19/2020 5:20:20 PM



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