Test makers are moving fast, but the coronavirus may be moving faster

In Lake Success, a village on the border of suburban Long Island and the New York City borough of Queens, there is a building that was erected to house defense engineers during World War II. It was designed to withstand enemy bombing, with a pool of water on the roof to help camouflage it in the event of airstrikes.

Today, it is on the front line of a very different war.

The building now serves as the diagnostic testing hub for Northwell Health, a New York health care system with 23 hospitals and 800 outpatient centers. It was one of the first centers to ramp up testing for SARS-CoV-2, the virus that causes Covid-19, and can now run almost 2,000 tests a day. It returns results within a day, sometimes less. Inside, the pace has been furious.

“I don’t think I’ve slept more than four hours in weeks,” said Dwayne Allen Breining, a pathologist and the lab’s executive director. “We’re going at this full speed.”

Across the country, many labs are doing the same. After a month of painful failures by U.S. regulators to expand testing for the coronavirus, the Food and Drug Administration has issued a flood of clearances to manufacturers of testing machines, allowing an estimated 100,000 tests to be run a day. It is a vast improvement of the testing situation just weeks ago.

The question is whether it’s enough.

Whereas a few weeks ago 100,000 tests a day might have helped contain the explosion in new cases — by allowing doctors to tell infected patients to quarantine themselves — it is now hardly enough to keep up with an exponential rise in new infections.

Nationally, the number of Covid-19 cases has passed 160,000, with 66,000 of those cases in New York state and 38,000 in New York City. Clusters are blossoming in cities including Miami, Detroit, and elsewhere, submerging hospitals under a wave of patients who are short of breath from viral infections

Over the next few weeks, the country’s testing capacity is likely to increase further, to perhaps several hundred thousand a day, with some tests able to give results in hours or even minutes. The big question, though, is this: Can diagnostic tests outrace the coronavirus?

By now the U.S. failure to expand testing has been well-documented. Efforts by the wealthiest country in the world paled in comparison with those of other countries. And local and state officials have been furious about it.

When New York Gov. Andrew Cuomo toured Northwell’s testing facility at Lake Success three weeks ago, he lambasted U.S. regulators for not having authorized the lab to conduct coronavirus testing.

Northwell “has automated testing, which expands exponentially the number of tests that can be done,” Cuomo said. “CDC has not authorized the use of this lab, which is just outrageous and ludicrous.” The next day, the lab was cleared by the FDA to start testing patients. Its capacity at the time was 90 tests per day.

That number might not seem like a lot — and it isn’t in the context of nationwide spread. But if the pandemic has taught us anything, it’s that diagnostics are complicated.

The initial test at Northwell was based on the one developed by the Centers for Disease Control and Prevention itself. That test had accuracy problems that had slowed implementation, but even the later version had another problem: It didn’t allow a laboratory to test a lot of cases at once. 

At Northwell, it took a lot of effort to test a very small number of patients. “It takes four of my best techs in the lab working on that thing nonstop for a couple shifts to be able to crank out 70 tests a day,” said Breining, the lab director.

Breining’s tried to automate testing with machines from a company called GenMark, a Carlsbad, Calif.-based firm. He might have been able to use that machine, with his existing manpower, to run 600 tests a day. But, as with many other tests, there were limits in how many tests and reagents were available. In mid-March, the system was allowing the lab to test about 120 patients a day.

On March 16, the FDA granted Hologic, a Marlborough, Mass.-based company, an emergency use authorization for a SARS-CoV-2 test that runs on its Panther Fusion system. That system would allow users to run 1,150 tests in a 24-hour period. For Northwell, the machine would become a workhorse.

But for any new test on a new machine, Breining said, there is an “un-compressible” period of two weeks during which the machine must be put through its paces and validated. So even as the FDA approves new testing systems, laboratories have been racing to catch up.

The Hologic machine now accounts for the largest share of the laboratory’s volume, allowing it to keep on top of daily testing for the patients at its hospitals and of its health care workers. A Northwell spokesman said the company now has “sufficient capacity” in terms of hospital beds, but is making preparations to respond to a further surge in infected patients if necessary.

To control the pandemic, Breining said, you’d want to test enough people that the percent of positive tests falls to about 10%. At Northwell, this “positivity rate” can approach 50% on some days. 

“That positivity rate tells us we’re only testing a fifth of the patients we’d want to be testing, ideally, if we had unlimited testing available,” Breining said.

Over the past month, the U.S. has taken dramatic steps to be able to test more patients for SARS-CoV-2. In a statement Monday, FDA Commissioner Stephen Hahn said that the agency had worked with 230 test developers since January, and approved 20 tests. The agency also began relaxing regulations so that laboratories like Northwell’s could get up and running more quickly.

An automated test from Roche was approved on March 13, potentially providing 400,000 tests a week. The next day, the FDA approved a test to run on a machine made by Thermo Fisher, which said it would aim to provide 5 million tests by the end of April. The following week, the agency approved a test from LabCorp and the Hologic test. At the time, Hologic said it would be able to provide about 600,000 tests a month.

Even as capacity expanded, doctors and patients have reported long wait times for results. LabCorp and Quest initially had official turnaround times of several days; some patients still report waiting as much as a week for a result. 

The FDA has given emergency clearance for a test from Danaher that takes just 45 minutes and is targeted at emergency rooms. Abbott Laboratories received emergency approval for a test that runs on a small desktop machine and can return results in five minutes. Abbott said it can manufacture 50,000 of the tests a day.

But all that capacity, even if it can deliver results fast, won’t quite make up for lost time. Consider the case of  the Stanford Clinical Virology Laboratory, which began working not with the CDC’s test, but with the alternative one that had been developed by German researchers and used by the World Health Organization. By the time the FDA eased regulations, Stanford launched testing in a matter of days, and was soon testing 1,000 patients a day. It hurts to imagine what would have happened had more labs been as prescient.

What will it take to get to a situation that doesn’t require the entire population to be huddled at home, trying to slow the spread of the coronavirus so that the volume of infected people does not overwhelm our hospital system? Experts say that to some extent, the answer is that it’s a waiting game. Spread of the virus must slow enough so that testing can catch up. 

It won’t just be a matter of having enough diagnostic tests, but also having public health workers locate people who might be infected to test them as well as being able to return results to patients quickly. These are probably the big bottlenecks, now. A recent report from the American Enterprise Institute co-authored by former FDA Commissioner Scott Gottlieb puts the number of tests needed at 750,000 tests per week. There will also need to be a different kind of test, to detect antibodies against the virus to identify people who have already been infected and may have immunity.

The story of U.S. diagnostic testing in this case hasn’t been a failure of innovation alone, but also of logistics. After the first tests reached the market, there were shortages of other chemicals, including kits for extracting the virus before a test could be run. Then, hospitals started running out nasal swabs.

To make use of the surging test capacity, the U.S. is going to have to do better. And as fast as diagnostic companies have moved, it may not be fast enough.

A virus is a terrible thing to race.