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A box of BinaxNow home COVID-19 test produced by Abbott and QuickVue home test produced by Quidel will be sold at a CVS store in Lakewood, Washington, south of Seattle on Monday, November 15, 2021. (Associated Press)
While developing a rapid test to detect coronavirus in someone’s saliva, Florida startup Blink Science heard some shocking news: The U.S. Food and Drug Administration has more than 3,000 emergency use authorization applications, but not enough The resources to pass them.
"We want to avoid the EUA quagmire as much as possible," said Peb Hendrix, vice president of operations at the startup. Its testing is still in the early development stage. Based on the consultant’s advice, the company is weighing alternative ways to enter the US market through the FDA.
"This is how our government works," Hendricks said, which is a challenge for companies that "are eager to get started and think they have something to help."
The United States produced the COVID-19 vaccine in record time, but nearly two years after the pandemic, consumers have few options for cheap tests that can quickly screen for infection, even though they are widely available in Europe. Experts say that the lack of testing and high prices have undermined the efforts of the United States to return to normal life.
Some experts say that the FDA’s method of clearing rapid tests has been burdensome and has paid too much attention to the abnormal accuracy of positive results, rather than what is truly beneficial to the public: rapid results. The main purpose of the quick test is to screen people so that they can safely attend work, school, conferences, or parties. This screening can then be subjected to a more sensitive, laboratory-based polymerase chain reaction (PCR) test for diagnosis.
The FDA only authorized 12 over-the-counter options for rapid testing. But the problem is beyond the scope of the agency: The Biden administration recently invested $3 billion to increase the supply of rapid testing, but public health and industry experts said the government did not act quickly enough to support development and manufacturing in the early stages of the pandemic.
"Should we have a test equivalent to operating warpage speed?" asked Mara Aspinall, co-founder of the life science fund BlueStone Venture Partners and board member of OraSure Technologies. OraSure Technologies has been authorized by the FDA to conduct over-the-counter rapid testing. "Absolutely.... For a long time, people thought that testing was extra, not the core, and needed to be regarded as the core."
According to FDA spokesperson Jim McKinney, during the pandemic, the FDA has received more than 4,500 requests for emergency use authorization and COVID testing. The agency said it is prioritizing reviews of home and bedside tests that can be mass-produced. McKinney said that the two recently authorized tests alone can increase usability up to 13 million times per day, adding that it will "effectively review submissions that have the greatest impact on national testing needs."
In addition to the slow approval speed, the manufacturing bottleneck caused by the shortage of materials and labor also keeps prices high. The price of rapid testing ranges from US$14 for two packages to more than US$50 per test, which is far from affordable for regular use.
The FDA stated that it cannot act faster because it needs to strike a balance between ensuring that safe and useful devices enter the market with the urgent need to provide options for extensive routine testing.
In response to the question, McKinney said: "The FDA carefully weighed the known and potential risks of emergency use authorization for COVID-19 diagnostic tests and the benefits of... based on reliable science." But he pointed out that many opinions The book is "incomplete or contains insufficient information".
Start-ups say that navigating the ins and outs of this regulatory mechanism is a daunting task. E25Bio in Cambridge, Massachusetts is developing a low-cost antigen test that detects COVID by identifying proteins called antigens. Since July 2020, as the FDA updated its recommendations, the company has repeatedly adjusted its FDA applications. The requirement to report test results directly to federal health authorities adds to the delay.
"As a smaller company, we didn't have the ability to develop this technology at first," said co-founder and chief scientific officer Bobby Brooke Herrera. E25Bio now has a mobile app that can verify the results and send anonymous data to public health authorities.
Another speed bump: The FDA requires clinical trials in the United States, which makes the company's data from Latin America unusable.
Herrera hopes to sell this over-the-counter rapid test in the United States for less than $5, which is cheaper than any product currently on the market.
Hendrix said that Blink Science is considering different ways to obtain FDA approval. It is called de novo and can be used to bring new, low-risk medical devices to the market. He said that for now, the company may give priority to obtaining approval in developing countries where vaccination rates are much lower than those in the United States.
Steradian Technologies wanted to launch a 30-second breath test, but regulatory consultants and others who encountered obstacles in the EUA process told it that it "may not be worth it" because the agency has so much support. Tra Tran, Director of Corporate Development and Clinical Affairs. The FDA's routine approval process may be the best option.
"We didn't have the budget to do EUA, and were told,'Well, you actually wasted six months and hundreds of thousands of dollars,'" she said. "Only certain people can afford to stay in the FDA's regulatory process forever."
Several public health experts and people in the testing industry said that the Biden administration’s recent measures will help supply, but it will take time to meet demand.
Australian test manufacturer Ellume received US$232 million in federal funding in February to promote its rapid home testing of American manufacturing, but the company said its new plant in Frederick, Maryland will not start production until December . It can eventually produce 15 million tests per month.
The FDA approved Ellume's over-the-counter COVID test in December 2020, but the road was bumpy: the company recalled 2.2 million tests in the United States due to "higher than acceptable false positive" results, the FDA said, and the FDA warned , Their use "may cause serious adverse health consequences or death." All from Ellume's Australian factory.
IHealth Labs was authorized by the FDA on November 5, and its two-piece test price was $14, and said that by January it will be able to conduct 200 million tests per month.
OraSure's goal is to conduct 4 million COVID tests per month by January and 8 million tests per month by June. It plans to expand to 200 million COVID tests every year-but by 2024.
Scott Gleason, OraSure's interim chief financial officer, said the company's plant in Lehigh Valley, Pennsylvania is facing headwinds. He said: "We have encountered some challenges in hiring enough people to work in our factories to meet demand." It won't drop anytime soon.
Ellume faces a shortage of cotton swabs, steel for facilities, and electronic components for testing.
The FDA has authorized more than 400 COVID tests, including home tests and tests handled by medical providers or laboratories. The FDA still receives more than 100 EUA submissions for COVID testing every month, many of which come from overseas. However, McKinney said that most of them are not the type most needed now: over-the-counter tests.
The FDA may be reluctant to relax its review. The first iteration of rapid tests for the pandemic, such as ID Now from Abbott Laboratories, has raised safety and accuracy concerns. The FDA has issued warning letters to at least six companies that sell false rapid tests and has repeatedly recalled them. In addition, the agency included more than 260 tests to detect COVID antibodies on the "not used" list.
Venture capitalist Aspinar said: "If we conduct antibody tests on antigen tests, we will completely destroy the credibility of the test." "Although this is frustrating, I must respect the FDA to ensure that we continue to conduct quality testing. "
According to the assessment of consulting firm Booz Allen Hamilton, the agency's review time for EUA applications for COVID testing has improved. Approval is usually faster than rejection. As of March, the median time for the FDA to grant authorization was 7 days, and the median time for rejection was 38 days. When the country is not in a state of national emergency, it may take months or years to pass the FDA review.
Despite this, Americans trying to protect the safety of employees and their families still feel the bottleneck.
LabCentral-a biotechnology collaboration facility in Cambridge, Massachusetts that is part of the E25Bio testing research-requires participating startups to test employees twice a week. Celina Chang, vice president of LabCentral, said this is a costly security measure for non-profit organizations, so it recently purchased a quick test from Germany for $1.50 each.
"In order to test people twice on a regular basis for several months," she said, "we need it, just like anyone, can afford it."
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