FDA authorizes first COVID-19 point-of-care diagnostic

FDA granted Emergency Use Authorization to Cepheid’s Xpert Xpress SARS-CoV-2 test, the first point-of-care diagnostic for COVID-19. The approval of the test, which can be run in 45 minutes, is FDA’s latest step to ramp up diagnostic capacity in the U.S.

Current testing for COVID-19 in the U.S. is centered on PCR-based tests that have limited capacity, take several hours to read out and need to be run in centralized or references labs.

The new rapid RT-PCR test can be performed anywhere Cepheid’s GeneXpert hardware is installed, which includes many of the hospitals where patients are being treated.

More than 23,000 GeneXpert cartridge-based molecular diagnostic systems have been installed worldwide, almost 5,000 of which are in the U.S.

Last month, Cepheid partnered with Sherlock Biosciences Inc. to develop a CRISPR-based diagnostic on the GeneXpert platform. A CRISPR-based diagnostic should read out within 30 minutes, and could be available this season (see “CRISPR-Based Diagnostics are Poised to Make an Early Debut”).

The U.S. government has taken several other steps to expand testing capacity in recent days including FDA’s decision to allow each state to regulate COVID-19 testing (see “FDA Expanding U.S. COVID-19 Test Capacity”).

The Xpert Xpress SARS-CoV-2 test will begin shipping next week.

On Monday, FDA issued an Emergency Use Authorization for a separate COVID-19 diagnostic from Novacyt S.A. (LSE:NCYT; Euronext:ALNOV). The company’s real-time PCR test, which can produce results in under two hours, is CE-IVD marked in Europe.

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