FDA Approves Curative Inc's COVID-19 Test

The Food and Drug Administration approved COVID-19 testing startup Curative Inc.'s saliva test for emergency use — opening up the door to larger-scale distribution.

The move by the federal agency provides a hopeful sign for the company which is working to develop mass at-home testing that could be used to help open up the country's economy.

As of Friday, 3.5 million people have been tested in the United States, according to data from Johns Hopkins University. But as officials from President Donald Trump on down look to jumpstart the national economy and lift stay-at-home orders, the availability of testing will need to be widespread, public health experts say.

Curative has processed 57,700 tests, nearly a quarter of all those administered in California, Curative founder Fred Turner said on Twitter Friday. Turner set up shop in a San Dimas lab last month and became an unsung hero in the battle to combat coronavirus in Southern California when he turned the focus of his company, originally meant to detect sepsis, to the pandemic.

The tests take a little over a day to process and have been among the quickest turnarounds in the region. Curative is processing about 5,000 test results daily and producing 20,000 test kits a day. The test has been used since March 21, but with this approval, Curative can further ramp up production and distribute nationwide.

The saliva tests pose less risk to health care workers than the tests that require a nurse to swab inside a person's nose. The company has been testing first responders in Los Angeles County.

With this authorization, the company said, it was prepared to start working with new distributors including healthcare systems, states, and city governments.

Hospitals, grocery stores and warehouses are all struggling to figure out how to keep essential workers safe. More than 22 million people have filed for unemployment since the pandemic erupted in the United States and employers are struggling to figure out how to keep essential workers safe.

Abbott Laboratories Inc. announced this week it would begin shipping a new coronavirus blood test that can tell whether a person has ever been infected with hopes of ramping up to to produce 20 million tests a month by June.