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FDA approves Northwell Health Labs in Lake Success for COVID-19 tests

Leon Falk, a technical specialist, runs tests in

Leon Falk, a technical specialist, runs tests in a Panther Fusion machine at the Northwell Health Labs facility in Lake Success last week. Credit: Howard Schnapp

Northwell Health Labs said it plans to immediately start processing tests for COVID-19, the disease caused by the novel coronavirus, after receiving federal approval late Sunday.

Officials at Northwell said the lab can manually process 90 potential COVID-19 samples the first day of operation. They are hoping to get further approval from the U.S. Food & Drug Administration for automated testing, which would increase the number of tests it could handle on a daily basis into the hundreds.

“Now that the accuracy of our testing process has been validated, we can begin notifying providers and patients of their lab results and start gearing up for an automated testing process that would enable us to significantly expand the number of samples we can process,” Dr. Dwayne Breining, executive director of Northwell Labs said in a statement.

Earlier Sunday, Gov. Andrew M. Cuomo toured the main Northwell Health Labs 100,000-square-foot facility in Lake Success and vented his frustration at federal officials for not allowing it to process tests sooner, saying it was “outrageous and ludicrous.” He also criticized the U.S. Centers for Disease Control and Prevention for not ramping up testing at its own lab when the virus was first detected in the United States earlier this year.

Before Sunday, samples of possible COVID-19 cases from New York could only be processed at the state’s Wadsworth lab or New York City’s Public Health lab.

"While this approval is a good first step, the FDA must increase the testing capacity for the state and private labs, because the more tests we run, the more positive people we will find and the better we can control and contain the virus,” Cuomo said in a statement issued Sunday evening. “It's one thing for the federal government not to have the testing capacity in place themselves — that was bad enough — but there's no excuse for them not to be authorizing existing labs to do the work.”

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