“As a smaller company, we didn’t have the capabilities to develop that technology at first,” said Bobby Brooke Herrera, co-founder and chief science officer. E25Bio now has a mobile app that verifies results and sends the anonymized data to public health authorities.
Another speed bump: The FDA requires U.S. clinical trials, making the company’s data from Latin America unusable.
Herrera hopes to sell the over-the-counter rapid test in the U.S. for less than $5, cheaper than anything currently on the market.
Hendrix said Blink Science is considering a different path to FDA approval. Known as de novo, it can be used to bring novel, low-risk medical devices to market. For now, he said, the company is likely to prioritize approval in developing countries where vaccination rates are much lower than in the U.S.
Steradian Technologies, which hopes to launch a 30-second breath test, says it was told by regulatory consultants and others who ran into snags in the EUA process that it “might not be worth it” because the agency is so backed up, according to Tra Tran, the company’s director of development and clinical affairs. The FDA’s regular approval process might be the best option.
“We don’t have the budget to spend on doing an EUA and then being told, ‘Well, actually you wasted six months and hundreds of thousands of dollars,’” she said. “Only certain people have the capital to be able to afford staying in this FDA regulatory process for forever.”
The Companies’ View
Several public health experts and people in the testing industry said that the Biden administration’s recent moves will help supply but that meeting demand will take time.
Australian test-maker Ellume received $232 million in federal funds in February to boost U.S. manufacturing of its rapid at-home test, but the company says its new plant in Frederick, Maryland, won’t start production until December. It could eventually manufacture 15 million tests a month.
The FDA authorized Ellume’s over-the-counter covid test in December 2020, but the road has been rocky: The company recalled 2.2 million tests in the U.S. because of “higher-than-acceptable false positive” results, the FDA said, and the FDA warned that their use “may cause serious adverse health consequences or death.” All came from Ellume’s Australian facility.
IHealth Labs, which received FDA authorization Nov. 5 for a test priced at $14 for a two-pack, says that by January it will be able to make 200 million tests a month.
OraSure aims to make 4 million covid tests a month by January and 8 million a month by June. It plans to scale up to 200 million covid tests annually — but not until 2024.
Scott Gleason, OraSure’s interim chief financial officer, said the company faces headwinds at its plant in Pennsylvania’s Lehigh Valley. “We’re having some challenges with hiring enough people to work in our factories to meet the demand,” he said. A two-pack has recently retailed between $14 and $24, and that price won’t drop anytime soon, Gleason said.
Ellume has faced shortages of swabs, steel for its facility and electronics components for the tests.
The View From the FDA
The FDA has authorized more than 400 covid tests, including at-home options and those processed by a medical provider or a lab. The FDA is still getting more than 100 EUA submissions for covid tests per month, many from overseas. But, McKinney said, the vast majority are not for the type most needed now: tests for over-the-counter use.
The FDA may be reluctant to ease its scrutiny. The pandemic’s first-iteration rapid tests, like Abbott Laboratories’ ID Now, raised safety and accuracy concerns, and the FDA has sent warning letters to at least six companies selling bogus rapid tests and has issued numerous recalls. Separately, the agency put over 260 tests that detect covid antibodies on a “do not use” list.
“If we did to antigen tests what happened with antibody tests, we would completely destroy the credibility of the test,” said Aspinall, the venture capitalist. “As frustrating as this is, I have to respect the FDA for ensuring that we continue to have quality tests.”
The agency’s review times for covid test EUA applications have improved, according to an assessment by consulting firm Booz Allen Hamilton. Approvals were generally cleared faster than denials. As of March, the median time for the FDA to grant authorization was seven days and 38 days for denials. When the country isn’t in a national emergency, getting through the FDA’s reviews might take months or years.
Nonetheless, the bottlenecks are felt by Americans trying to keep their employees and families safe.
LabCentral — a biotech co-working facility in Cambridge, Massachusetts, that was part of E25Bio’s testing study — requires participating startups to test workers twice a week. That’s a costly safety measure for a nonprofit, said Celina Chang, LabCentral’s vice president, so it recently bought rapid tests from Germany for $1.50 each.
“In order to test people twice a week on a regular basis for months on end,” she said, “we need it to be, just the same as anyone, affordable.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
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