Months-Long Delays and Mysterious Rejections Plague Rapid COVID Testing in US

A few weeks ago, there was a ProPublicaReporter decided to test his children for COVID-19. He was concerned about their health and set up a grandparent visit to check them.

This was the problem that COVID-19 cheap tests were meant to solve. You don’t need to wait days or go to a doctor to get your results. Just pick up a pack of tests at a local pharmacy whenever you want, swab your nose and learn within 15 minutes if you’re likely to pass the virus along.

Also, ProPublicanIn the hope of buying the required pack for $23.99, he went to his local CVS. They were out-of-stock. He then went to Rite Aid. They didn’t have the tests either. Next came Walgreens and then another CVS. All out of stock. The only supplier that offered a few tests was his sisterA few were found by a lucky recipient.

It’s a familiar experience for many Americans. However, it’s not the case for Brits who can get free rapid testsDelivered to their homes upon request Or France. GermanyOr BelgiumAt-home tests are as common as decent cappuccino in this area.

Hence, why is it so difficult to find at-home testing in the United States?

The answer appears to be a confounding combination of overzealous regulation and anemic government support — issues that have characterized America’s testing response from the beginning of the pandemic.

Companies trying to get the Food and Drug Administration’s approval for rapid COVID-19 tests describe an arbitrary, opaque process that meanders on, sometimes long after their products have been approved in other countries that prioritize accessibility and affordability over perfect accuracy.

The FDA issued a call for faster tests in the summer 2020. WHPM, Inc., a biotech company based in Los Angeles, began to work on one. They did. peer-reviewed trial following the agency’s directions, then submitted the results this past March.

WHPM’s head of international sales Chris Patterson stated that in May, the FDA revieweder sent a confusing email asking for information. However, it had already provided it. WHPM responded in two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies, and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be “deprioritized,” or moved to the back of the line.

“We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,” said Patterson. The WHPM Rapid Test has been approved in Mexico, and the European Union where large orders have been placed.

A scientist at the FDA who reviewed COVID-19 test applications, told ProPublicaHe was so frustrated by the delays that he left the agency earlier in the year. “They’re neither denying the bad ones or approving the good ones,” he said, asking to remain anonymous because his current work requires dealing with the agency.

FDA officials stated that they just want rapid tests to detect low levels of the virus. False negative results could allow people to spread the disease unknowingly. They attribute the lack of sufficient public funding to European governments for the test shortages. Without it, manufacturers have lacked confidence that going through the FDA’s process would be financially worth the trouble.

“Where we have seen tests truly coming to the marketplace, the big difference has been government investment,” said Dr. Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health, which authorizes tests. “Folks will come and do larger volumes because you’re supporting production, which can also help drive down prices.”

Both Trump and Biden administrations had a similar view: vaccines must be able to end the pandemic quickly. They also delayed large-scale COVID-19 test purchases that Americans could keep in medicine cabinets.

As a result, one of the few companies that has successfully gotten tests authorized and onto shelves — Abbott Laboratories — has dominated the market. Its BinaxNOW tests account for around 75% of U.S. retail sales, according to data from NielsenIQ, even though they’re sold here for several times the price of the same Abbott tests in Europe.

In the last two months, the Biden administration taken stepsTo make home testing more accessible. The shelves of pharmacies are filling up as more prescriptions are approved and more purchase orders signed.

Manufacturers may still feel that this is not enough. scrambleTo build supply chains capable to deliver the tens to millions of tests per semaine that public health experts believe will be required to keep schools open and workplaces safe. Employers who have been charged with testing their entire workforce have been in a difficult spot. bidding warsTo ensure adequate supply

The delays, like the slow ramp up of lab testing at beginning of pandemic, have come at a price.

“It feels like in one place we’re in a rocket ship and in another place we’re on training wheels,” said Rep. Kim Schrier, D-Wash.Contrasting vaccines and testing. Schrier, a former pediatrician who has been pushing the agency to authorize more rapid tests, said, “You can’t count on the free market during a pandemic.”

Since the outbreak of the pandemic in the USA, the U.S. testing response has been a mess. It oscillates between caution and overcorrection.

The Centers for Disease Control and Prevention spent weeks developing its own test in February 2020. It was published later. turned out to have falsely flaggedOther viruses may also be present, allowing COVID-19 to gain ground in the U.S.

The FDA was then more permissive. allowingAfter a cursory review, privately-developed tests that detected antibodies from previous infections were allowed to enter the market. The FDA rejected dozens of these tests. prohibited their use.

Meanwhile, the FDA grappled with thousands of applications for “emergency use authorizations,” or EUAs. While the process for EUAs takes less time than for full approval, it still requires extensive clinical and real world evaluation. Most EUAs issued have been for PCR tests, which are highly sensitive — meaning they can detect even low levels of the virus — but typically take days to return results.

Antigen tests are another form of diagnostics that can quickly and cheaply return results, similar to a pregnancy check. They’re less sensitive, but usually good enough to determine whether someone is infectious.

Recognizing the potential market, more EUA applications were submitted by companies in late 2020. The FDA was cautious about this type test, mostly because of the risk of false positives in the early stages of infection.

FDA officials were especially concerned about the possibility of tests being administered without the supervision of a trained healthcare provider. “To mitigate the impact of false results, all Covid-19 tests authorized to date have been made available only by prescription, so that clinicians can interpret results for patients,” wrote Shuren and his deputy Dr. Tim StenzelIn an October 2020 column in The New England Journal of Medicine

Despite increasing agitation from Congress regarding the availability of testing, the cautious approach was maintained throughout winter and spring.

“I actually have been saying that for months and months and months, we should be literally flooding the system with easily accessible, cheap, not needing a prescription, point of care, highly sensitive and highly specific” tests, White House chief medical advisor Dr. Anthony Fauci said under questioning from Schrier in a hearing on March 17.

Stenzel, a microbiology Ph.D., is the director of the office that authorizes diagnostic test approvals. He has the most direct control over whether a test is approved or denied. Before joining the FDA, he spent most of his career at biotech companies. Some wonder if these relationships may have played a role in determining which testmakers were the most important in the market.

Among Stenzel’s former employers were Abbott and the San Diego-based Quidel Corporation, the first two companies to sell self-administered, prescription-free COVID tests in large volumes.

Doug Bryant, Quidel CEO, stated in a promotional video that in early 2020, the company wasn’t planning on designing a COVID-19 test until he got a call from a trusted contact at the FDA. Stenzel confirmed that he was that contact.

About a year later, Quidel’s and Abbott’s at-home tests were approved. An earnings call, Quidel’s Bryant said it was “the most significant inflection point for our company.” In the third quarter of 2021, Quidel made $406 million from its various COVID-19 tests, blowing past Wall Street’s expectations. “There is no denying Quidel has put itself in position to win big in COVID-19 testing,” wrote an analyst with the firm William Blair. Abbott made $1.9 billionGlobally, the COVID-19 tests.

Ethics disclosures show that Stenzel holds no Abbott or Quidel stock, and it’s been several years since he worked at either company. But Stenzel’s ties to the two major test manufacturers and the slow pace of authorizations for other companies’ at-home tests drew a letterThe American Economic Liberties Project, an anti-monopoly thinktank, calls for an investigation.

Stenzel denied any improper conduct and pointed out his office issued recalls for both Abbott and Quidel due to problems with other COVID-19 testing. He also noted that the office designed relatively easy-to-follow templates for new types of COVID-19 tests to help companies that hadn’t dealt with the FDA before.

“We understood that there were a bunch of companies that were new to the FDA, and we provided them an immense amount of support, saying, ‘This is how you do it,’” Stenzel said.

FDA has said it “engaged with more than 100 test developers” about making diagnostics. The agency declined to name the test developers, citing confidentiality concerns.

QuidelYou can find more information atcknowledged the administration had reached out, but didn’t comment on its discussions with Stenzel, while Abbott said it had spoken to “many people across multiple areas of government” early in the pandemic.

Most companies don’t have the same familiarity with the people adjudicating their applications.

Nanōmix, a diagnostics designer based in Emeryville, California, developed a rapid testWith the help of a federal grant, Nanomix completed the application and submitted it to FDA in February. In early June, an FDA reviewer sent back a list of questions, giving Nanōmix a deadline of 48 hours to respond. The company couldn’t provide answers that quickly, so it was sent to the back of the line.

“We start development on a set of guidance,” said Nanōmix CEO David Ludvigson. “Then they change the guidance after we’re done, and expect us to have conformed to their revised guidance.”

FDA has been particularly cautious about testing with more innovative approaches, such a COVID-19 symptom that causes loss of smell. The agency’s reviewers deprioritized an application for the scratch-and-sniff cardEven though it was proven to be true stem transmissionDerek Toomre, an inventor and professor at Yale School of Medicine, stated that it is possible to do so.

Other companies, large and small, were also caught up in FDA demands that seemed minor when compared to the urgency of the situation.

Roche, a biopharmaceutical company, was one example. ProPublicaIt submitted a home test in the early 2021 but the FDA rejected it because the trials were partly done in Europe. The test had comparedfavorably with Abbott’s rapid test, and receivedJune European Union approval The company intends to submit a second application before the end of this year.

A smaller company, which didn’t want to be named because it has other contracts with the U.S. government, withdrew its pre-application for a rapid antigen test with integrated smartphone-based reporting because it heard its trial data from India — collected as the delta variant was surging there — wouldn’t be accepted. The trials in the U.S. could have cost millions.

The FDA reviewer who resigned in May described the internal causes of the delays. Because he had a background in virology, the FDA reviewer could quickly assess hundreds of pages within a matter of days. But then, something bizarre happened: The applications would remain in limbo for months as higher-ups seemed paralyzed from indecision.

“I could easily process dozens of them, but I ended up with one or two in my queue constantly. They would stay there forever,” he said. “I had a lot of free time.”

His experiences are reflected in outside reviewBooz Allen Hamilton conducted an evaluation of the EUA process. It found that the FDA took 99 days to make a decision on original applications, up from 29 in April. Denials took significantly longer than authorizations. The assessment also found “limited understanding in the test developer community on how to appropriately validate a diagnostic test.”

Stenzel stated that delays could be attributed to careful review. He also said that many applications were incomplete or contained poor data.

“If we have questions or concerns about a test, they will not be prioritized the same way a test will be that we have fewer questions about,” Stenzel said. “Those will be cycled to the front, and it makes good public health sense to move forward those tests that are most likely to pass muster and get authorized. … There are always good reasons for why something is delayed.”

European countries generally have similar guidelines regarding the accuracy of tests but are less strict about how trials should be conducted. For example, antigen test developers can limit their sample to high-viral load subjects, who perform better in tests.

The FDA, however, remains concerned that the typical method for measuring viral load isn’t consistent, leading to the risk of overestimating the accuracy of the test. Advocates of the European approach point out that being able to identify an infection in its earliest stages won’t help much if a PCR result doesn’t come back for days, so even a less sensitive at-home antigen test is valuable — especially since people are much more likely to be able to access them in the first place than PCR tests.

Europe’s differing approach has resulted in 39 rapid self-administered antigen tests being authorized by the European Union, according to a databaseArizona State University. The U.S. has granted permission for 12 prescription-free medications, of which nine are available without prescription.

A consultant who works with smaller companies trying to get products through the FDA — and who asked for anonymity in order to protect his clients who have business before the agency — said he understands the argument that more robust applications from companies with larger manufacturing capacity should go first.

The problem with this logic, he said, is that it’s now fall and the pandemic is ongoing, with the possibility of new variants still unknown. “And it’s not like you can flip a switch with the Defense Production Act and you’re going to get magically much more capacity,” he said. “We needed a ‘thousand flowers bloom’ approach. We needed everyone and their brother pitching in with these tests.”

The federal government could have also supported the supply of COVID-19 rapid tests by purchasing large quantities from companies that can manufacture them in bulk and then providing them to consumers at a low or zero cost.

Shuren and Stenzel suggested the same thing a year ago in their New England Journal of Medicine section. They wrote that the U.S. government should have authorized a handful of tests and had the CDC contract with those manufacturers, rather than trying to vet thousands of diagnostics, which they called “an inefficient use of resources.”

The European countries did both. They authorized dozens of rapid antigen test kits to be sold and contracted with a few companies that would provide millions of them for free to citizens. For example, the U.K. provided $50 billion in funding over two years for a new laboratory. national test and trace programIt can quickly test any person upon request. It hasn’t worked perfectly or averted lockdowns, but advocates argue it’s better than the U.S. alternative of rapid tests being nearly impossible to find.

For Germany’s free testing program, which ran from March through October, the government initially bought800 million rapid tests, 200 million home tests. shorter listManufacturers that had been subject to additional vetting. The country also requiredUnvaccinated individuals can present their latest test results for activities that involve congregating.

Although the U.S. government has spent billions of dollars on testing — estimates of the total vary, given the number of funding streams — self-administered tests are usually not covered by insurance, and there is no centralized system for distributing them.

The 2020-21 season will see the following: federal government spentPoint-of care tests cost hundreds of millions of dollars, but were mostly reserved for use at facilities such as nursing homes or military bases. March’s economic stimulus bill was passed. allocated $10 billion for screening in schools, which don’t usually rely on home tests. The focus then shifted to vaccines.

The CDC pushed hard for the message that vaccines are almost entirely protective, reducing the need to have frequent testing. This was interpreted by manufacturers as a negative sign for testing volumes. Abbott ramped downIt is being manufactured.

Stenzel seemed content with the availability and quality of the tests at that time. “We believe we’re doing a great job at meeting the public health need at this point,” he said in JuneOn his weekly townhall call with test developers.

Companies were less interested in new tests and it was difficult for promising concepts to be commercially picked up because there were no long-term government purchasing programmes. Iowa State University professors were able to use federal funding to accelerate COVID-related technology. Nigel Reuel developed a mailable paper test in April, but he said he’s not sure it’ll be worth it to take the step of clinical trials.

It’s really hard, Reuel said, for a company to “say we’re going to invest tons in this when we don’t know what the long-term market for it is.”

This meant that home tests were becoming increasingly difficult to obtain when the delta variant was introduced in July. The market share dropped slightly in September as a few other companies were able access the shelves.

You can find out more at earnings call in October, Abbott CEO Robert Ford said the company anticipated dropping its price to maintain its market share, but wouldn’t if competition didn’t make it necessary.

Asked why its rapid tests are abundant and cheap in Europe and scarce in the U.S., Abbott spokesperson John Koval chalked it up to Europe’s public support, both in its regulatory system and through government funding.

“It has taken more than a year for the American public, scientific experts and academia to accept the important role of rapid testing in the U.S.,” Koval said. “Overseas, that was not the case, because the value of rapid testing was better understood prior to the pandemic.”

Washington’s sentiment has been shifting. In late October, Sen. Dick Durbin sent a letter urging “appropriate flexibility in regulatory standards” for at-home tests. The White House has also announced $1 billion in purchase commitments to home tests over the past month. Recognizing the difficultyThe Department of Health and Human Services can quickly secure the required quantity of raw materials for testing. awarded13 companies will receive $560 million more to test components like swabs or pipette tip packaging, and other production capabilities.

Still, some of the government’s efforts haven’t added up to much.

The White House was inaugurated in September announcedKroger, Amazon, Walmart and Amazon would sell COVID-19 test at cost for the three months that followed. There was no subsidy and the retailers were often out-of-stock for the first two months. Tests available online are often sold by third-party distributors, and Amazon and Walmart said they don’t control those prices, so they remain high.

At CVS, which didn’t participate in the agreement with the White House, a Quidel kit — which costs $12 wholesale — still sells for $23.99.

Same with Rite Aid, but when one of us visited a store in Brooklyn this Wednesday, employees said they hadn’t received a shipment of BinaxNOW kits in a month, until they got seven the day before. “They immediately sold out. And that was limiting it to one per person,” said Roxanne, a pharmacy technician who declined to give her last name.

The U.S. is now taking more responsibility for testing validation. The National Institutes of Health was established last week. announced a new program to do much of the work for test developers, mitigating the back and forth around what’s good enough. Shuren said this process is similar to that of some European governments. However, the U.S. will continue to maintain stricter standards.

All of these steps would have been more useful if experts had started calling for them a whole year ago.

“We need to have a rethinking, during and after this pandemic, to talk about the role of testing,” said Mara Aspinall, who co-founded the Biomedical Diagnostics program at Arizona State University’s College of Health Solutions. “It’s a fundamental piece of our fight. And that was realized too late.”

Do you have any information about COVID-19? Email [email protected]You can also message her via Signal at 202-913-3777. Email [email protected]You can also message him at Signal (917-687-8406.