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Guardant Health Receives FDA Emergency Use Authorization for COVID-19 Sequencing Test

NEW YORK – Guardant Health, previously an exclusive developer of cancer liquid biopsy assays, said Monday that the US Food and Drug Administration has granted emergency use authorization for its newly-developed SARS-CoV-2 assay, Guardant-19.

Guardant-19 is an RT-PCR and next-generation sequencing test that detects coronavirus SARS-CoV-2 nucleic acids from upper respiratory nasal specimens including various nasal, nasopharyngeal and oropharyngeal swabs, washes, and aspirates.

According to the company, the assay has been validated with a limit of detection of 125 copies per mL. A multiplexed workflow allows the possibility to scale to over 10,000 tests per day, and Guardant can typically return results by the next day.

"While serving cancer patients remains our top priority, we are proud to be able to leverage our expertise in liquid biopsy testing to contribute to battling the COVID-19 pandemic by offering a highly accurate test that is truly additive to the testing options available today," Guardant Health president AmirAli Talasaz said in a statement.

The test is being offered to Guardant employees and used to test samples for select partner organizations including Delaware State University and the Healing Grove Health Center in San Jose, California.