Northwell Health Labs today began semi-automated testing for COVID-19, the disease caused by the novel coronavirus.
Through an emergency use authorization submitted Tuesday night to the US Food & Drug Administration (FDA), the lab now has approval to move immediately from manual testing to the lab’s semi-automated molecular diagnostic system, developed by GenMark Diagnostics, Inc.
“Since we began manual testing Sunday evening, we processed about 133 tests,” said Labs Executive Director Dwayne Breining, MD. “Moving to this semi-automated system will enable us to increase our testing capacity immediately to about 160 a day, and then to several hundred a day later this week.”
As a next step, the Lab is seeking FDA approval to fully automate the process, which would give it the capability to process more than 1,000 tests daily, he said.
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 or 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 110,000-square-foot 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.
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.