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Monday, August 24, 2020

Guardant Health gets U.S. emergency use nod for coronavirus test

The FDA has granted emergency use authorization (EUA) to Guardant Health’s (GH +0.3%) Guardant-19 test for use in the detection of the SARS-CoV-2 virus.

The test is a reverse transcriptase polymerase chain reaction next-generation sequencing test, that detects the coronavirus from upper respiratory nasal specimens. It has a validated limit of detection of 125 copies per mL and results are typically returned the next day.

The company says its testing workflow can be scaled to over 10,000 tests per day.


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