Why the U.S. Still Can’t Do Enough Coronavirus Testing


(Bloomberg Opinion) -- First of two columns.

In late January,  soon after a laboratory in Shanghai published the genome sequence of the coronavirus — and around the time Wuhan, China, went into lockdown — a scientist named Benjamin Pinsky began working on a test to identify people who were infected with the virus.

Pinsky is the medical director of the Stanford Clinical Virology Laboratory and a professor at the Stanford University School of Medicine. According to his Stanford bio, he spends about 20% of his time “focusing on the design of novel infectious disease diagnostics.” Even though the federal government, starting with President Donald Trump, seemed remarkably sanguine about the prospect of a pandemic sweeping the country, Pinsky thought the coronavirus was likely to become a problem for the U.S. 

“I didn’t know how severe it would be,” he told me. “I just thought it wouldn’t hurt to be prepared.”

The World Health Organization had published a working version of a reverse transcription polymerase chain reaction test — commonly known as a PCR test — which uses snippets of genetic material to diagnose a virus. Tests based on the WHO data were already in widespread use in China. In South Korea, the government drug ministry was corralling biotech companies, telling them to begin working on tests based on the same data. 

Pinsky also relied on the WHO protocols as he developed a PCR test. By early February, he had a test that he thought would work. And then he, and Stanford, waited, for weeks. That was all they could do until the federal government gave them the go-ahead to begin using it to diagnose the disease in patients.

For all its scientific know-how, the U.S has lagged behind in testing thanks to a combination of government hubris, incompetence and bureaucratic rigidity. Even now, there aren’t nearly enough tests being performed. According to the Covid Tracking Project, fewer than 500,000 tests have been done nationwide in March. It’s not even close to being enough.

If you want to understand why, Pinsky’s effort is as good a place as any to start. A scientist in a lab sees what is happening in China and takes it upon himself to develop a test — just in case. He adapts the WHO protocols to the specifics of his lab and the materials available to him (every lab is different, after all) and his test is ready to go in a matter of weeks.

With much less urgency, the federal government also begins working on a PCR test. But unlike Pinsky — not to mention most of the rest of the world — the Centers for Disease Control and Prevention decides not to follow the WHO’s protocols. Nobody knows why. Instead, the CDC develops its own test, which all the nation’s labs will then have to replicate. But when it sends out 200 test kits to 100 labs in February, many of them don’t work. The CDC then promises to quickly come up with new tests, but one day stretches into three and then 10. Finally, in late February, the agency essentially throws up its hands and loosens its restrictions on clinical labs to develop their own tests. Alas, by then it is way too late. 

Pinsky wasn’t the only one who hadn’t waited for the CDC to start developing a test. In Seattle, the first coronavirus hotspot in the U.S., Helen Chu, an epidemiologist at the University of Washington School of Public Health, had been conducting a research project into the flu that involved obtaining nasal swabs from flu-sufferers in the region.

According to the New York Times, Chu realized that those same swabs could also be retested for Covid-19. After waiting weeks to get the go-ahead from state and federal regulators, she finally began testing for coronavirus without government permission in late February. She soon discovered, as the Times put it, “the coronavirus had quickly established itself on American soil without anyone realizing it.”

How did government officials react to her work? They shut her down, on the grounds that privacy laws prevented her from using flu test swabs to test for Covid-19.

Pinsky, for his part, had spent February collecting the data he needed to validate the test he had developed. As soon as the CDC loosened its restrictions, he submitted his data to the government, and quickly got the go-ahead, under a new accelerated approval process. But his was only one lab, with limited ability to scale. The tests are not simple: They require a number of careful steps by skilled lab technicians as well as reagents and other materials, not to mention simple equipment like swabs and vials. All are now in short supply. 

According to Lloyd Minor, the dean of the Stanford School of Medicine, Stanford can perform 2,000 tests a day. It has conducted tests for nearby hospitals and is setting up a drive-through test area in a parking lot normally used for football-game parking. Even so, federal guidelines call for only people who show symptoms of infection to be tested. This is true across the country — precisely because the U.S. hasn’t caught up with the number of tests that are needed. As a result, even now, two months after the first confirmed case in Seattle, the country is flying blind.

“This is the greatest breakdown in public health in my lifetime,” said Eric Topol, the director of the Scripps Translational Science Institute, who has been tweeting about the U.S. testing deficiencies.

“For the entire month of February, the only place you could get a test was from the CDC,” he told me. “The U.S. and South Korea both had their first diagnosis on the same day. For the entire month of February, the U.S. conducted 472 tests. South Korea conducted 70,000. They were doing thousands every day, while the U.S. was doing zero.” The clear reason is that the South Korean government was proactive from day 1, while the Trump administration sat on its hands.

Even now, Topol continued, there has been no systematic effort at “contact tracing” — that is, tracking and isolating everyone who has been in recent contact with someone who has been diagnosed with Covid-19. Contact tracing is critical to slowing down a pandemic.

In the time since the CDC loosened its restrictions, the federal government has ceded some of its approval to state health authorities, according to Topol. But most states lack the expertise to make such judgments; that’s always been a federal responsibility. Dozens of labs across the country have developed tests, but all have limitations that prevent them from delivering the millions of tests that are needed. 

For instance, Roche Molecular Systems received approval recently for a test that will initially supply 400,000 tests a week in the U.S., according to Science magazine. But to utilize most of Roche’s tests, technicians need to use Roche equipment, and not all labs have that equipment. Both Quest Diagnostics and LabCorp have begun testing, but again, they have manpower and equipment shortage issues that make it impossible to scale, at least so far, to the extent the country needs. And so-called home tests aren’t like, say, a pregnancy test. Even after a person uses a swap to obtain a genetic sample, he or she still has to send it to a lab for diagnosis.

As we all know now, testing at scale is the single most critical tool in slowing down — and eventually stopping — a pandemic. Mass testing can show what percentage of the population has the virus and who needs to be isolated. The countries that were foresighted in developing tests in large numbers, such as  South Korea, are the ones that have done the best at minimizing the damage. 

So is there anything that can be done to overcome the federal government’s shortcomings? As it turns out, the PCR test isn’t the only test that could help stop the pandemic. A second one could have a huge effect on the ability of the U.S. to get back on its feet. It’s much simpler than the PCR test and much easier to scale. And it may be available very soon. That will be the subject of my next column.

This column does not necessarily reflect the opinion of Bloomberg LP and its owners.

Joe Nocera is a Bloomberg Opinion columnist covering business. He has written business columns for Esquire, GQ and the New York Times, and is the former editorial director of Fortune. His latest project is the Bloomberg-Wondery podcast "The Shrink Next Door."

©2020 Bloomberg L.P.

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