Blink Science, a Florida-based startup, heard something startling while developing a rapid test that detects the coronavirus in someone’s saliva: The Food and Drug Administration had over 3,000 emergency use authorization applications but lacked the resources to process them.
The United States produced covid-19 vaccines in record time, but nearly two years into the pandemic, consumers have few options for inexpensive tests that quickly screen for infection, despite the fact that they are widely available in Europe. According to experts, the scarcity of tests and their high prices undermine efforts in the United States to return to normalcy.
According to some experts, the FDA’s approach to clearing rapid tests has been onerous and overly focused on exceptional accuracy to detect positive results, rather than on what would truly benefit people as a whole: quick results. Rapid tests are primarily used to screen people so that they can safely attend work, school, meetings, or gatherings. This screening can then be followed up with a more sensitive, lab-based polymerase chain reaction (PCR) test for diagnosis.
Only 12 over-the-counter rapid test options have been approved by the FDA. However, the issues extend beyond that agency: The Biden administration recently committed $3 billion to increasing the supply of rapid tests, but public health and industry experts say the government did not move quickly enough to support development and manufacturing early in the pandemic.
According to FDA spokesperson Jim McKinney, the FDA has received over 4,500 emergency use authorization and related requests for Covid tests during the pandemic. According to the agency, it is prioritizing reviews of at-home and point-of-care tests that can be produced in large quantities. McKinney stated that two recently authorized tests alone could increase availability by up to 13 million tests per day, and that it would “efficiently review the submissions that will have the greatest impact on the nation’s testing needs.”
Aside from the slow pace of approvals, manufacturing bottlenecks caused by material and labor shortages keep prices high. Rapid test prices range from $14 for a two-pack to well over $50 per test, making them prohibitively expensive for regular use.
It is difficult for startups to navigate the intricacies of this regulatory apparatus. E25Bio, based in Cambridge, Massachusetts, is working on a low-cost antigen test that detects Covid by identifying proteins known as antigens. Since July 2020, the company has made numerous changes to its FDA application as the agency’s recommendations have changed. Delays have been exacerbated by the requirement that test results be reported directly to federal health authorities.
Blink Science, according to Hendrix, is considering a different route to FDA approval. It is referred to as de novo, and it can be used to bring novel, low-risk medical devices to market. For the time being, he believes the company will prioritize approval in developing countries where vaccination rates are much lower than in the United States.
According to Tra Tran, the company’s director of development and clinical affairs, Steradian Technologies was told by regulatory consultants and others who encountered snags in the EUA process that it “might not be worth it” because the agency is so backed up. The FDA’s standard approval procedure may be the best option.
The FDA has approved over 400 Covid tests, including those performed at home as well as those performed by a medical provider or a lab. The FDA continues to receive more than 100 EUA submissions for Covid tests per month, many of which come from outside the United States. However, the vast majority, according to McKinney, are not for the type most needed now: over-the-counter tests.
The FDA may be hesitant to loosen its grip. The pandemic’s first-generation rapid tests, such as Abbott Laboratories’ ID Now, raised safety and accuracy concerns, and the FDA issued warning letters to at least six companies selling bogus rapid tests as well as numerous recalls. Separately, the FDA placed over 260 tests for Covid antibodies on a “do not use” list.
According to an assessment by consulting firm Booz Allen Hamilton, the agency’s review times for Covid test EUA applications have improved. Approvals were generally processed more quickly than denials. As of March, the FDA’s median time to grant authorization was seven days, and its median time to deny authorization was 38 days. When the country is not in a state of emergency, it may take months or years to get through the FDA’s reviews.