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Talis Biomedical Gets FDA Emergency Use Authorization for SARS-CoV-2 Point-of-Care Assay

NEW YORK — Talis Biomedical said on Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Talis One COVID-19 point-of-care test.

The test is designed to detect the ORF1ab and N genes of SARS-CoV-2 in nasal swab specimens. It runs on the company's sample-to-answer Talis One molecular diagnostic system, which provides results in less than 30 minutes and was developed with funding under the National Institutes of Health's Rapid Acceleration of Diagnostics initiative.

Menlo Park, California-based Talis said earlier this year that it expects to manufacture up to 1 million of the SARS-CoV-2 tests per month before the end of the year. It is also developing tests for sexually transmitted diseases, women's health indications, and respiratory infections.