Diagnostics FDA Governments Innovation Press

FDA authorises Oral fluid test by Curative Inc. under EUA guidelines

COVID-19 testing startup Curative Inc. announced that the FDA has authorized its oral fluid test under Emergency Use Authorization (EUA) guidelines. The Curative test has been in use by the City of Los Angeles since March 21, and with this EUA, it can now be scaled and distributed nationwide.

Curative has helped more than 53,000 people get tested for COVID-19 through its easy to use oral fluid tests which have been demonstrated in clinical studies to have equivalent sensitivity to nasopharyngeal (NP) swabs. Unlike NP swab tests, the Curative test does not create an exposure risk for healthcare workers during sample collection and requires less Personal Protective Equipment (PPE) and can be scaled rapidly using an orthogonal supply chain.

The Curative team is currently processing approximately 5,000 test results per day and producing 20,000 test kits per day. The tests have an average turnaround time of 31 hours.

“Broad access to testing is critical to our nation’s response to COVID-19 and with this authorization, we can continue scaling and distributing our test nationwide,” said Fred Turner, CEO and founder of Curative Inc. “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. 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.” 

With this authorization, Curative is prepared to start working with new distributors including healthcare systems, states, and city governments. Currently, Curative is supplying drive-through testing organized by the Cities of Los Angeles and Long Beach as well as other testing organized by LA County and LA County Fire and Sheriff’s Department. Curative tests are not being sold to individuals at this time and must be ordered by a physician, per FDA guidelines.

Meeta Ramnani
Meeta Ramnani
Meeta develops credible content about various markets based on deep research, opinions from experts and inputs from industry leaders. As the managing editor at Smart Industry News, she assures that every piece of news and article adds to the knowledge of decision makers. An avid bike rider, Meeta, is a postgraduate from Indian Institute of Journalism and New Media (IIJNM) Bangalore, where her specialization was Business Journalism. She carries experience from mainstream print media including The Times Group and Sakal Media Group.