After a visit to its sophisticated, 100,000-square-foot diagnostic facility by New York Governor Andrew Cuomo, Northwell Health Labs today received state and federal authorization to begin manual testing for COVID-19, the disease caused by the novel coronavirus.

Utilizing a testing process developed and approved by the New York State Department of Health (DOH), Northwell’s Lab expects to manually test 90 potential COVID-19 samples within the first full day, said Dwayne Breining, MD, executive director of the Northwell Labs. With one of North America’s largest automated testing lines, the facility processes about 20 million tests annually. Beyond the manual testing authorized today, Northwell Labs is seeking the US Food & Drug Administration’s approval to use semi-automated testing within the next week. This would give the laboratory the capability to process hundreds of tests daily, with a plan to ramp up to thousands daily in the near future.

“Over the past week, we’ve been developing the test for COVID-19, thanks to the assistance we‘ve received from New York State’s DOH Laboratory,” said Dr. Breining. “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.”

While the expanded ability to test patients for COVID-19 will greatly enhance Northwell’s ability to manage patients with potential infection, testing will continue to be reserved for those at risk for severe disease and who have had confirmed close contact with an infected individual.

“Only people who meet that criteria will be tested – and that testing is currently being performed at hospital emergency departments and urgent care centers,” said John D’Angelo, MD, chair of emergency medicine at Northwell, which operates 18 emergency departments throughout New York City, Long Island and Westchester County. “Even as our testing capacity increases, we will continue to screen people judiciously so we can focus our attention on those most at risk for severe COVID-19 infection who require more-immediate and intensive medical attention. All others who are concerned about exposure but who have mild or no symptoms should recuperate at home.”

Built at a cost of $60 million and opened in 2019, Northwell’s Core Lab within the health system’s Center for Advanced Medicine in Lake Success performs testing for Northwell’s 23 hospitals and 800 outpatient facilities, as well as thousands of physician offices and dozens of other hospitals, including NYC Health+Hospitals.

At a news conference Sunday morning, Governor Cuomo called on the federal government to speed up its authorization process to allow more clinical laboratories to begin testing for COVID-19. “This is one of the most technologically advanced labs in the state of New York, and one of the most sophisticated labs in the United States of America. This lab can do high-throughput automated testing, which expands exponentially the number of tests that can be done,” Governor Cuomo said. “Let’s increase as quickly as possible our testing capacity so we identify the positive people, so we can isolate them and be successful in our containment.”

Several hours after the Governor’s news conference, Northwell received approval to move forward with the manual testing.

Northwell Health President & CEO Michael Dowling praised the Governor and state Department of Health for their leadership in responding to the coronavirus epidemic. “I thank the Governor for not only giving us the support we need to begin testing for COVID-19, but also in declaring a state of emergency that will help expedite the procurement of emergency provisions, such as testing kits and cleaning supplies,” said Mr. Dowling.

To prepare its lab to begin COVID-19 testing, Northwell has invested over $2 million in recent weeks for lab supplies and equipment, part of an overall outlay of more than $5 million the health system has spent over the past seven weeks on coronavirus preparation.

Source: Company Press Release