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Responding to Coronavirus Test Shortage, FDA Lets NY State Health Department Authorize Assays

NEW YORK – Responding to a severe shortage of tests for the novel coronavirus in the state of New York, the US Food and Drug Administration on Thursday gave the New York State Department of Health permission to authorize New York laboratories to begin patient testing.

In a statement issued on Friday, the agency said it is "not objecting" to the NYSDOH's approach, under which labs need to provide validation data to the health department within 15 days of starting testing instead of having to pursue an Emergency Use Authorization with the FDA.

FDA said its decision was based on the fact that NYSDOH "has a long-established framework in place for [the] oversight of laboratory-developed tests in New York State" and that it has previously accredited the health department's Wadsworth Center in Albany as a third-party reviewer for certain molecular tests.

"This NYSDOH action shows the FDA's extreme flexibility and adaptability during times of public health emergencies," said FDA Commissioner Stephen Hahn in a statement, adding that New York labs "will interact solely with NYSDOH, which should expedite the availability of patient testing in New York State."

New York's governor Andrew Cuomo said on Thursday that the state is partnering with 28 private labs over the next several weeks and that the first drive-through testing facility will open in New Rochelle on Friday. He also said that the state is contracting with Opko Health's BioReference Laboratories to provide testing for this and other locations. BioReference plans to offer 5,000 tests per day, which will become available next week.

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