'Ludicrous': Cheap, Quick COVID-19 Tests Have Been Slow To Gain FDA Approval, A


Every day, a Pasadena, California-based company ships eight cargo jets loaded with COVID-19 tests to the United Kingdom. Innova Medical Group's top executive would like to use the rapid tests to slow infections closer to home. Los Angeles County hospitals overflowed with patients amid record deaths this winter during the darkest phase of the pandemic. But Innova has not yet secured Food and Drug Administration authorization to sell the tests in the United States. Instead, test-packed jets fly overseas to serve British Prime Minister Boris Johnson's "moonshot" of mass testing. “I’m a bit frustrated,” said Daniel Elliott, president and CEO of Innova Medical Group. “I think we’ve done everything we’ve possibly had to do, need to do and have been asked to do to get the testing through the approval process.” More studies are underway to demonstrate the accuracy of Innova's test, which costs less than $5 and can deliver results within 30 minutes. Researchers at Harvard, the University of California, San Francisco and Colby College have evaluated the test and other private research groups are conducting trials on people with or without coronavirus symptoms, Elliott said. Experts say the United States could quickly expand the nation's limited testing supply and improve speed by authorizing rapid, paper-based antigen tests such as Innova's diagnostic. Advocates say these tests are cheaper, easier to make and can be used two to three times each week to detect when someone is infectious and likely to pass the virus to others. The drawback: Rapid tests are less precise when compared to lab tests, which take longer to complete and cost $100 or more. The Biden administration is endorsing both methods – investing in quick and cheap antigen tests and lab-based polymerase chain reaction, or PCR, tests, which have been the mainstay since last spring. Earlier this month, administration officials announced six unidentified suppliers will deliver 61 million rapid tests by the end of summer. The Department of Defense also reached a $230 million deal with Australia-based Ellume to open a U.S. factory and make 19 million antigen tests each month, 8.5 million of which will be provided to the federal government.

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