FDA greenlights oral fluid test for COVID-19

The FDA has given its blessing to an oral fluid test for the novel coronavirus developed by California diagnostic startup Curative Medical, allowing its use nationwide.

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Capable of using sputum as well as samples taken with nasal and oral swabs, the test has already been in use by the city of Los Angeles since late March, according to the company. The option of collecting oral fluid can lessen the risks of exposure for healthcare workers, compared to deep nose swabs. 

Curative was founded in January to develop diagnostics for sepsis. After pivoting toward COVID-19, the company said it is currently processing about 5,000 tests per day with an average turnaround time of 31 hours, while producing about 20,000 kits daily.

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“Our work with the Cities of Los Angeles and Long Beach has helped thousands of people access testing at drive-through facilities and we are fully equipped to expand that access to help thousands more across the country,” said Curative founder and CEO Fred Turner. 

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“At the same time, we are continuing to work with the FDA to validate our test for at-home collection, which would expand access even more,” Turner added. 

The prescription COVID-19 test is being offered through a partnership with nearby KorvaLabs, based in San Dimas, California, which previously offered anti-doping testing for various sports leagues and organizations as well as other services out of its CLIA-certified laboratory.