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UPDATED: FDA Authorizes Fast Track Use Of Two COVID-19 Tests That Offer Results In Hours Instead of Days

They're made by two CA firms, one in Cypress, one in Sunnyvale


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(March 22, 2020, updated 9:30 a.m. from initial 6:30 a.m.) -- The U.S. Food and Drug Administration issued an emergency use authorizatrion for COVID-19 tests developed by two CA firms -- one in nearby Cypress -- that can provide test results within hours instead of days.

In a March 21 release, the FDA announced that it has issued the first emergency use authorization "for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test" developed by Cepheid, a Sunnyvale, CA firm. The FDA says the "Xpert Xpress SARS-CoV-2 test [is] for use in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings. The company intends to roll-out availability of its point-of-care testing by March 30." In a company release, Cepheid states in pertinent part that "The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes."

"Point of care" means where doctors or other professionals take care for patient (such as an ER or hospital. >Cepheid says it currently has nearly 5,000 GeneXpert® Systems in the US capable of point-of-care testing and for use in hospitals. It says its "automated systems do not require users to have specialty training to perform testing - they are capable of running 24/7, with many systems already doing so now. The company says itstest will begin shipping next week

The FDA has also issued emergency use authorization for a test developed and manufactured by DiaSorin Molecular LLC of Cypress. The firm's Simplexa COVID-19 Direct kit {company release text] "provides a sample-to-answer test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, directly from nasopharyngeal swab specimens." DiaSorin says the "Simplexa COVID-19 Direct kit is designed for use on the LIAISON® MDX. It can be utilized by hospital laboratories without the need to send the sample out, allowing for timely testing and results. The kit contains an all-in-one reagent mix which is ready to use. Only one instrument and one reagent are required to perform the test. It bypasses the need for traditional extraction procedures, enabling rapid detection in a little over an hour which is significantly faster than the up to seven hours currently required by traditional extraction followed by amplification technologies, ultimately allowing prompt decision making regarding isolation of infected patients..."

DiaSorin says its product "has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research,"

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CA and LB officials have sought to emphasize the importance of social distancing and protective measures while downplay the importance of test results to individuals. In a recent media briefing, CA Governor Gavin Newsom argued that test results are more important to officials to indicate the extent and locations of COVID-19 regional spread.

In recent days, a New Orleans woman, age 39, belatedly tested for COVID-19, was found dead in her kitchen a few days later while waiting for delayed test results. (New Orleans Times/Picaune coverage here.)

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LB Mayor Robert Garcia hasn't responded to LBREPORT.com's inquiry (made days ago to the City's Joint Information Cneter) inquiring with whom he'd spoken personally about expediting drive-through testing in Long Beach (already available at two locations in Riverside County as well as at least two locations in the Bay Area.) Garcia has acknowledged he'd like to see more testing available but reiterated LB City Hall's official stance that the City is currently following CDC protocols and guidelines.

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