By KAREN RUBIN
Hours after Gov. Andrew Cuomo took the federal government to task for failing to authorize private laboratories to test for the novel coronavirus and for failing to authorize automated testing, the FDA gave its approval to testing at Northwell Health Laboratories in Lake Success.
“After days of advocating the FDA and the federal government to expand testing capacity for the novel coronavirus in New York State and working with Northwell and [the state lab at] Wadsworth to expedite the process, we just received word that Northwell Laboratories has been authorized to test under Wadsworth’s emergency use authorization,” Cuomo said Saturday. “Manual testing of 75 to 80 samples per day will begin at Northwell immediately, but we still need automated testing approved so we can perform thousands per day.”
Testing is critical to finding people infected with the coronavirus in order to contain the spread of the infection, he said during a tour of Northwell Health Laboratories in Lake Success, where as many as 1,000 tests could be done a day using its state-of-the-art automated testing devices. The devices can handle as many as 120 samples at one time.
The $60 million, 150,000-square-foot Northwell laboratory is the most sophisticated lab in New York State and one of the most advanced in the nation, according to hospital officials. The federal government has yet to authorize the semi-automated testing systems at Northwell.
“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. “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.”
Earlier in the day, the governor implored the Trump administration to open up testing. “Let’s increase as quickly as possible our testing capacity so we identify the positive people so we can isolate them and we’re successful in our containment,” he said.
The state is “continuing to test people and is working with hospitals and local governments to give them the resources they need to contain the spread of this virus,” Cuomo said. “We mobilized quickly but the federal government has been slow off the mark and they continue to be slow. That’s unacceptable. We need them to approve these private labs today so we can stay ahead of this evolving situation. Worse than the virus right now is the fear pandemic – and getting these additional facilities online will ensure we have more facts that will help keep people calm.”
The Northwell lab on Long Island is the first private lab in the state to handle coronavirus testing. The laboratory’s executive director, Dr. Dwayne Breining, said that Northwell Labs is seeking the FDA’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,” Breining said. “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, according to Dr. John D’Angelo, the system’s chair of emergency medicine.
“Only people who meet that criteria will be tested – and that testing is currently being performed at hospital emergency departments and urgent care centers,” D’Angelo said. “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.”
“This is an extraordinary facility,” the governor said, flanked by state Health Commissioner Howard A. Zucker and Northwell Health CEO Michael J. Dowling. “We are trying to contain the spread of virus and to do that, we are testing as many as possible, to find the positives and isolate them.”
If the spread of infection is not contained, Cuomo warned, more disastrous measures, such as China and Italy have been forced to undertake – massive quarantines of millions of people – “would be very disruptive to society and the economy.”
Cuomo said that the level of fear surrounding coronavirus is unwarranted. “There is more fear, anxiety than facts would justify. This isn’t Ebola, or SARS. This is a virus we have a lot of information on. Johns Hopkins has been tracking 100,000 cases [the number globally] and what happens.”
He said most people who become infected will experience mild symptoms like a cold or flu and can recover at home. But for vulnerable populations – the elderly, people who have medical conditions – the disease is dangerous and can be deadly.
The best “weapon” against the disease is to reduce situations that create density.
Cuomo said he is speaking with business leaders across the state to encourage them to offer liberal sick leave so that people who are sick, who feel symptoms, stay home but are still paid; he also is encouraging businesses as well as state and local government offices, to stagger workers in shifts if possible; and to allow work at home where feasible.
Individuals also have a role, he said – to wash hands, not shake hands, just as in any flu season. He advises people who take mass transit to let a train pass if the cars are too packed and to move to less crowded cars. “Reduce density, proximity,” he said.
The governor also addressed price gouging, which is happening across the state and the nation, “symptomatic of fear.”
Also, travel insurance companies and travel agents will offer New York residents and businesses the ability to purchase coverage when making travel plans that would allow them to cancel a trip for any reason, including reasons related to COVID-19. Six global and national insurance companies have agreed to offer “cancel for any reason” coverage to travelers, including Allianz, Nationwide, Starr Indemnity, Berkshire, Crum & Forster and Zurich.
“We do not want to have to do massive close-downs, massive quarantines, and we don’t want members of the vulnerable population getting sick,’’ Cuomo said.
“That is why we are doing what we are doing.
“And to New Yorkers, we understand the facts. Keep this in perspective. We don’t want a lot of people getting this virus. We don’t want to take more drastic measures. But, if you get the virus, you will get sick, you will recover, you most likely won’t even go to the hospital. And the only people who we really have to worry about are the vulnerable populations – senior citizens, people with compromised immune systems.
“So keep it all in perspective. I know there’s a whole frenzy about it; the facts do not justify the frenzy, period. The biggest problem we have in this situation is fear, not the virus. The virus we can handle. It’s the fear. And the fear is just unwarranted,” Cuomo declared.
