While developing a rapid test that detects the coronavirus in a person’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration had more than 3,000 applications for emergency authorization and lacked the resources to get through them. to come .
“We want to try and avoid the EUA swamp,” said Peb Hendrix, the startup’s vice president of operations. The test is still in its infancy. On the advice of advisors, the company is considering an alternative route through the FDA to the US market.
“It’s just the way our government works,” Hendrix said, challenging companies that are “concerned about getting started and think they have something that can help.”
The US produced COVID-19 vaccines in record time, but nearly two years after the pandemic, consumers have few options for low-cost tests that quickly screen for infection, although they are widely available in Europe. Experts say the lack of tests and their high prices are undermining efforts in the US to return to normal life.
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Some experts say the FDA’s approach to clearing rapid tests was cumbersome and focused too much on exceptional accuracy to detect positive results, rather than on what would really benefit people: quick results. The main use of rapid tests is to screen people so that they can safely go to work, school, meetings or gatherings. This screening can then be followed by a more sensitive, lab-based polymerase chain reaction (PCR) test for diagnosis.
The FDA has approved only 12 over-the-counter rapid test options. But the problems go beyond that agency: The Biden administration recently put $3 billion into boosting the supply of rapid tests, but public health and industry experts say the government didn’t get early enough. pandemic acted to support development and production.
“Should we have had an Operation Warp Speed equivalent for testing?” asked Mara Aspinall, a co-founder of the life sciences fund BlueStone Venture Partners and a board member of OraSure Technologies, which received FDA clearance for an over-the-counter rapid test. “Absolutely. … For too long people thought that testing was a perk and not the core, and it should be seen as the core.”
During the pandemic, the FDA has received more than 4,500 emergency use authorizations and related requests for COVID testing, according to FDA spokesman Jim McKinney. The agency says it prioritizes assessments of home and point-of-care tests that can be produced in large quantities. Two recently approved tests alone could increase availability by as many as 13 million tests per day, McKinney said, adding that it would “efficiently assess the submissions that will have the greatest impact on the nation’s testing needs.”
In addition to the slow pace of approvals, production bottlenecks caused by material and labor shortages are keeping prices high. Quick test prices range from $14 for a two-pack to over $50 per test, far from affordable for regular use.
The FDA says it can’t get any faster as it ensures safe and useful devices reach the market with the urgent need to provide options for widespread daily testing.
“The FDA is carefully weighing the known and potential risks and … benefits of emergency use authorization for diagnostic tests for COVID-19 based on sound science,” McKinney said in response to questions. But he noted that many submissions are “incomplete or contain insufficient information.”
Startups said navigating the ins and outs of this regulatory device is daunting. E25Bio of Cambridge, Massachusetts, is developing a low-cost antigen test, which detects COVID by identifying proteins called antigens. Since July 2020, the company has repeatedly amended its FDA filing as the agency updates its recommendations. The requirement for test results to be reported directly to federal health authorities has exacerbated delays.
“As a smaller company, we didn’t initially have the capabilities to develop that technology,” said Bobby Brooke Herrera, co-founder and chief science officer. E25Bio now has a mobile app that verifies the results and sends the anonymized data to public health authorities.
Another speed bump: The FDA requires clinical trials in the US, rendering the company’s data from Latin America useless.
Herrera hopes to sell the over-the-counter rapid test in the US for under $5, cheaper than anything currently on the market.
Hendrix said Blink Science is considering another path to FDA approval. It is known as de novo and can be used to market new low-risk medical devices. For now, he said, the company will likely prioritize approval in developing countries where vaccination rates are much lower than in the US.
Steradian Technologies, which hopes to launch a 30-second breath test, says it was told by regulatory advisers and others who had problems with the EUA process that it “might not be worth it” because the agency is so backed, according to Tra Tran, the company’s director of development and clinical affairs. The regular FDA approval process may be the best option.
“We don’t have the budget to spend doing an EUA and then be told, ‘Well, basically you’ve wasted six months and hundreds of thousands of dollars,'” she said. “Only certain people have the capital to afford to stay in this FDA regulatory process forever.”
The opinion of the companies
Several public health experts and those in the testing industry said the Biden administration’s recent moves will help supply, but it will take time to meet demand.
Australian testmaker Ellume received $232 million in federal funds in February to boost U.S. production of its rapid home test, but the company says its new plant in Frederick, Maryland, won’t begin production until December. It could eventually produce 15 million tests per month.
The FDA approved Ellume’s over-the-counter COVID test in December 2020, but the road was rocky: The company recalled 2.2 million tests in the US due to “higher than acceptable false positive” results, the FDA said, and the FDA FDA warned that its use “may cause serious adverse health effects or death”. They all came from the Australian branch of Ellume.
IHealth Labs, which received FDA authorization on Nov. 5 for a test that costs $14 for a two-pack, says it will be able to perform 200 million tests per month by January.
OraSure aims to have 4 million COVID tests per month by January and 8 million per 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 is facing headwinds at its Lehigh Valley plant in Pennsylvania. “We have some challenges with hiring enough people to work in our factories to meet the demand,” he said. A two-pack recently sold for between $14 and $24, and that price isn’t going to drop anytime soon, Gleason said.
Ellume has faced shortages of cotton swabs, steel for its facility and electronic components for the tests.
The view from the FDA
The FDA has approved more than 400 COVID tests, including at-home options and those processed by a healthcare provider or lab. The FDA still receives more than 100 EUA submissions for COVID testing each month, many from abroad. But, McKinney said, the vast majority aren’t for the type that’s most needed right now: over-the-counter tests.
The FDA may be reluctant to ease its scrutiny. The pandemic’s first rapid tests, such as Abbott Laboratories’ ID Now, have raised concerns about safety and accuracy, and the FDA has sent warning letters to at least six companies selling fake rapid tests and has launched numerous recalls. Separately, the agency placed more than 260 tests that detect COVID antibodies on a “do not use” list.
“If we did with antigen testing what happened with antibody testing, we would completely destroy the credibility of the test,” said Aspinall, the venture capitalist. “Frustrating as this is, I have to respect the FDA to make sure we continue to do quality testing.”
Agency review times for COVID test EUA applications have improved, according to a review by consultancy Booz Allen Hamilton. Approvals were generally approved faster than rejections. As of March, the median time for the FDA to grant approval was seven days and 38 days for denials. If the country is not in a national emergency, it could take months or years to pass the FDA’s assessments.
Nevertheless, the bottlenecks are being felt by Americans trying to protect their employees and families.
LabCentral — a biotech co-working facility in Cambridge, Massachusetts that was part of E25Bio’s pilot study — requires participating startups to test employees twice a week. That’s a costly security measure for a nonprofit, said Celina Chang, LabCentral’s vice president, which is why it recently bought rapid tests from Germany for $1.50 each.
“To test people twice a week on a regular basis for months,” she said, “we need to be affordable, like everyone else.”