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FDA Clears High-Volume Covid-19 Test


(Gerd Altmann, Pixabay)

13 Mar. 2020. The Food and Drug Administration cleared for use in the U.S. a high-volume diagnostic for the novel coronavirus that can run on automated systems already in place. The agency also gave the go-ahead to to the New York State health department to begin patient testing in some of its labs.

FDA gave Roche an emergency use authorization, or EUA, to distribute test kits for the SARS-CoV-2 virus, responsible for Covid-19 infections, that run on cobas 6800 and 8800 systems made by Roche’s diagnostics division. A global case tracking dashboard hosted by Johns Hopkins University says as of today (13 March), more than 135,000 cases are reported in 120 countries, leading to nearly 5,000 deaths. In the U.S., some 1,700 Covid-19 cases are confirmed, with 40 deaths attributed to the disease.

The Roche Diagnostic test assesses throat swab specimens analyzed on the company’s cobas 6800 and 8800 systems. Roche says the tests will be administered to people meeting clinical or or epidemiological criteria for testing. The diagnostic uses reverse transcriptase–polymerase chain reaction, or RT-PCR analysis that test for SARS-CoV-2 viral RNA in the specimens.

The cobas 6800 and 8800 systems also automate many of the analytical steps, making possible more than 1,300 tests a day on the cobas 6800, and some 3,000 tests a day on the cobas 8800 systems. Roche says there are already 695 cobas 6800 and 132 cobas 880 systems deployed worldwide.

FDA also authorized some of New York State’s public health labs to begin testing patients for the Covid-19 virus, to meet “the urgent public health need for additional testing capacity.” While not an emergency use authorization, the agency’s decision gives New York State’s health department authority to validate tests for the virus developed internally. FDA says the state’s health department has a long-established framework for oversight of its testing labs.

The slow response by federal agencies and the relatively low rate of Covid-19 testing in the U.S. has drawn criticism, even from inside the Trump administration. Yesterday, in testimony to Congress, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, part of National Institutes of Health, said, “The system is not really geared to what we need right now, what you are asking for. That is a failing. Let’s admit it.”

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