Thursday, December 2, 2021

Why You Can’t Find Cheap COVID Home Tests

While developing a rapid test that detects coronavirus in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The FDA had over 3,000 emergency approvals, and he didn’t have the resources to test them. …

“We want to avoid the EUA quagmire,” said Peb Hendrix, the startup’s vice president of operations. His test is still at an early stage of development. On the advice of consultants, the company is weighing an alternative route through the FDA to the US market.

“This is how our government works,” Hendrix said, which is a challenge for companies that “want to get started and think they have something to help.”

In the United States, COVID-19 vaccines were produced in record time, but nearly two years after the pandemic began, consumers have few cheap test options that quickly detect infection, although they are widely available in Europe. Experts say the paucity of tests and their high cost are undermining US efforts to get back to normal.

READ MORE: 2 more over-the-counter home tests for COVID-19 allowed in US

Some experts say the FDA’s approach to cleaning up rapid tests has been cumbersome and overly focused on exceptional accuracy for detecting positive results, rather than what actually benefits people in general: quick results. Mostly rapid tests are used to test people so they can safely attend work, school, meetings, or meetings. This screening can then be supplemented with a more sensitive laboratory polymerase chain reaction (PCR) test for diagnosis.

The FDA has approved just 12 over-the-counter rapid tests. But the challenges go beyond this agency: The Biden administration recently poured $ 3 billion to boost the supply of rapid tests, but public health and industry experts say the government didn’t move quickly enough at the start of the pandemic to support development and production.

“Should we have had the equivalent of Operation Warp Speed ​​to test?” asked Mara Aspinall, co-founder of the life sciences foundation BlueStone Venture Partners and a board member of OraSure Technologies, which has received FDA approval to conduct an over-the-counter rapid test. “Absolutely. … For too long, people have thought of testing as an add-on rather than a core, and it should be seen as a core.”

During the pandemic, the FDA received more than 4,500 emergency use approvals and related requests for COVID tests, according to FDA spokesman Jim McKinney. The agency says it prioritizes home and point-of-care test reviews, which can be produced in high volumes. McKinney said just two recently approved tests could increase availability by as much as 13 million tests a day, adding that this “will effectively address applications that will have the greatest impact on a country’s testing needs.”

In addition to the slow pace of permitting, production bottlenecks caused by material and labor shortages are keeping prices high. Prices for rapid tests range from $ 14 for a pack of two to over $ 50 per test, which is nowhere near available for regular use.

The FDA says it cannot move faster as it balances ensuring that safe and useful devices go to market with the urgent need to provide options for widespread daily testing.

“The FDA carefully weighs the known and potential risks and… the benefits of authorizing emergency use of COVID-19 diagnostic tests based on sound scientific evidence,” McKinney said in response to questions. But he noted that many of the materials are “incomplete or contain insufficient information.”

Startups said it was difficult to understand the intricacies of this regulatory apparatus. E25Bio of Cambridge, Massachusetts is developing an inexpensive antigen test that detects COVID by identifying proteins called antigens. The company has repeatedly revised its FDA filing since July 2020 as the agency updates its guidelines. The requirement that test results be reported directly to federal health authorities added delays.

“As a small company, we didn’t have the capacity to develop this technology at first,” said Bobby Brooke Herrera, co-founder and chief scientist. E25Bio now has a mobile app that checks results and sends anonymous data to health authorities.

Another speed bump: The FDA requires clinical trials in the US, making the Latin American companies unusable.

Herrera hopes to sell an over-the-counter rapid test in the US for less than $ 5, which is cheaper than anything currently on the market.

Hendricks said Blink Science is considering another route to FDA approval. Known as de novo, it can be used to bring new low-risk medical devices to market. For now, he said, the company is likely to prioritize vaccination approval in developing countries, where vaccination rates are much lower than in the United States.

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Steradian Technologies, which hopes to launch a 30-second breath test, says regulatory consultants and others who faced difficulties in the EUA process told her it “might not be worth it” because the agency has such support. , according to Tran Tran, director of development and clinical operations for the company. A regular FDA approval process may be your best bet.

“We don’t have the budget to spend on EUA, and then they tell us, ‘Well, you actually wasted six months and hundreds of thousands of dollars,” she said. “Only certain people have the capital to allow themselves to stay in this FDA regulatory process forever.”

Companies view

Some public health experts and testing experts said recent moves by the Biden administration would help the supply, but it will take time to meet demand.

Australian test maker 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 will not begin production until December. Ultimately, it will be able to produce 15 million tests per month.

The FDA authorized Ellume to conduct an over-the-counter COVID test in December 2020, but the road has been a rocky one, with the company recalling 2.2 million tests in the United States due to “false positives that are above acceptable levels,” the FDA said, and the FDA warned its use “May cause serious adverse health effects or death.” All came from the Australian enterprise Ellume.

IHealth Labs, which received FDA approval on November 5 to conduct the test at $ 14 a pack of two, says it will be able to run 200 million tests a month by January.

OraSure plans to run 4 million COVID tests per month by January and 8 million per month by June. He plans to conduct up to 200 million COVID tests annually, but not until 2024.

Scott Gleason, interim chief financial officer of OraSure, said the company is facing challenges at its plant in Pennsylvania’s Lehigh Valley. “We have some problems hiring enough people to work in our factories to meet demand,” he said. The double pack recently retailed for between $ 14 and $ 24, and that price won’t drop anytime soon, Gleason said.

Ellume faced a shortage of tampons, steel for its equipment and electronic components for testing.

View from the FDA

The FDA has approved over 400 tests for COVID, including at home and in healthcare facilities or laboratories. The FDA still receives over 100 EUA applications for COVID tests per month, many from overseas. But according to McKinney, the vast majority of them are not for the type that is needed most now: tests for over-the-counter use.

The FDA may be reluctant to facilitate its scrutiny. Rapid tests of the first iteration of the pandemic, such as Abbott Laboratories’ ID Now, raised concerns about safety and accuracy, and the FDA has sent out warning letters to at least six companies selling fake rapid tests and issued numerous reviews. Separately, the agency has listed more than 260 tests that detect COVID antibodies on the “do not use” list.

“If we did the same with antigen tests as we did antibody tests, we would completely undermine the test’s credibility,” said Aspinall, a venture capitalist. “As frustrating as it is, I have to respect the FDA for continuing to run quality tests.”

Consulting firm Booz Allen Hamilton estimates the EUA’s processing time for COVID testing has decreased. Claims are usually confirmed faster than rejections. As of March, the average time it took for the FDA to issue approvals was seven days and 38 days for denials. When there is no emergency in a country, an FDA review can take months or years.

However, Americans are feeling bottlenecks in trying to keep their employees and families safe.

LabCentral – a collaborative biotechnology center in Cambridge, Massachusetts that participated in the E25Bio test study – requires participating startups to test workers twice a week. “This is an expensive security measure for a nonprofit organization,” said Selina Chang, vice president of LabCentral, so the company recently purchased rapid tests from Germany for $ 1.50 each.

“To test people twice a week on a regular basis for several months,” she said, “we need this to be affordable, like everything.”

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