PASADENA, Calif. – OmniPathology, a lab in Pasadena, has a newly developed test for COVID-19.
Doctor Mohammad Kamal is the founder of OmniPathology. Since 2009 the lab has specialized in gastrointestinal pathology and cytogenetic testing.
Everything shifted once the novel coronavirus hit.
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“Pretty much, by the way, we pretty much dropped everything and focused on doing that because we could see the significance and the impact of the virus,” said Dr. Kamal.
The test takes two hours. They can run 110 tests per day. That capacity could increase fivefold in the coming weeks.
Part of why Dr. Kamal is so confident in this test is the accurate results it has generated so far. When his team ran known negative and positive samples of COVID-19 the test always correctly identified these controls.
OmniPathology plans to submit for the U.S. Food and Drug Administration’s Emergency Use Authorization.
From the FDA:
“An Emergency Use Authorization, put into place by Congress, is a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and allows for expedited FDA review.”
Dr. Kamal expects to receive approval in April.
Many insurance companies promised to cover the cost of testing for COVID-19, but Dr. Kamal isn’t optimistic this will even cover the lab’s expenses.
“This test doesn’t pay a lot of money,” said Dr. Kamal.
The test is done by health care providers. They insert a swab inside the patient’s nose and then send the sample off to a lab.
Dr. Kamal worries a lack of medical supplies, specifically these swabs, could slow down COVID-19 testing.