LIVERMORE — A small Livermore company has developed a 15-minute test for COVID-19 infection that it believes is accurate and cheap enough to change the way the disease is diagnosed in schools, airports and other settings.
The company, Kaya17, has applied to the FDA for emergency use authorization. If it gets the authorization it is hoping for, perhaps in the next month or two, the company expects to be ready to manufacture and ship 30,000 to 50,000 testing kits within weeks, ramping up to several million kits a few months later.
Most components of the COVID-19 testing kit are fairly simple to make and will be easy to manufacture, according to company CEO Sulatha Dwarakanath.
Dwarakanath is an entrepreneur with a PhD in cancer biology from New York University who has managed efforts at several biotech companies to create improved tests for HIV, hepatitis, cervical, breast cancer and other diseases. She co-founded the company with Sri Satyanarayana, an engineer with a PhD from Columbia University, who is likewise an entrepreneur.
Tests for COVID-19 infection that are widely available in the U.S. now can take days to produce results.
While she can’t be certain of FDA’s response to Kaya17’s application for an emergency use authorization, Dwarakanath says she is optimistic at the prospect for approval because of the test’s speed, accuracy and promise of low cost.
If FDA does give the green light, the company has been in touch with manufacturers that it considers reliable that should be able to ramp up production rapidly.
Validation studies carried out at Arizona State University’s Biodesign Institute have shown the test to be 98% accurate at identifying the COVID-19 virus, called SARS-CoV-2, she said. These compared the Kaya17 results to those of PCR ‘gold standard’ tests.
The Kaya17 test reads fluorescent tags on biological molecules called antibodies that bind selectively to spikes on the surface of the SARS-CoV-2 virus. The reader is linked to a small computer which spews out results two minutes later. Since the test starts with a saliva sample, it promises to be more acceptable and less intrusive for patients than are uncomfortable nasal probes.
With organized workflow protocols, the company estimates that a single reader could test 20 people per hour. A cluster of five readers might test 100 in an hour, perhaps at an airport where passengers are screened for a flight or at a school where students are tested before class.