While developing a rapid test that detects the coronavirus responsible for COVID-19 in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration (FDA) had received more than 3,000 emergency use authorization applications, and it didn’t have the resources to get through them.
“We want to try to avoid the EUA quagmire,” said Peb Hendrix, vice president of operations for Blink Science.
The company’s test is still in early development. On the advice of consultants, it’s weighing an alternative route through the FDA to the U.S. market.
“It’s just the way our government works,” Hendrix said, which is a challenge for businesses that are “anxious to get started and think they’ve got something that can help.”
The United States produced COVID-19 vaccines in record time, but nearly two years into the pandemic, consumers have few options for cheap tests that quickly screen for infection, though such tests are widely available in Europe. Experts say the paucity of tests and their high prices undermine U.S. efforts to return to normal life.
Some experts say that 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 really benefit people en masse: speedy results. The main use of rapid tests is to screen people so that they can safely attend work, school, meetings, or gatherings.
The FDA has authorized just 12 over-the-counter options for rapid tests. But the problems go beyond that agency. The Biden administration recently put $3 billion toward boosting the country’s supply of rapid tests, but public health and industry experts say that the government didn’t move quickly enough early in the pandemic to support development and manufacturing.
“Should we have had an equivalent of Operation Warp Speed for testing?” asked Mara Aspinall, co-founder of life sciences fund BlueStone Venture Partners and a board member for OraSure Technologies, which has received FDA authorization for an over-the-counter rapid test. “Absolutely. ... For too long, people thought of testing as an extra and not the core, and it needs to be thought of as the core.”
During the pandemic, the FDA has received more than 4,500 emergency use authorization and related requests for COVID-19 tests, according to FDA spokesperson Jim McKinney. The agency stated that it’s prioritizing reviews of at-home and point-of-care tests that can be produced in high volumes. Two recently authorized tests alone could boost availability by as much as 13 million tests per day, McKinney said, noting that it would “efficiently review the submissions that will have the biggest impact on the nation’s testing needs.”
The FDA says that it can’t move more quickly as it balances ensuring that safe and useful devices reach the marketplace with the urgent need to deliver options for widespread daily testing.
“The FDA carefully weighs the known and potential risks and ... benefits of emergency use authorization for COVID-19 diagnostic tests based on sound science,” McKinney said.
However, he noted that many submissions “are incomplete or contain insufficient information.”
“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 of E25Bio. The company now has a mobile app that verifies results and sends the anonymized data to public health authorities.
Another obstacle is that 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 United States 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, the company is likely to prioritize approval in developing countries where vaccination rates are much lower than in the United States, he said.
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.
The Companies’ View
Several public health experts and people in the testing industry have said the Biden administration’s recent moves will help supply, but meeting demand will take time.IHealth Labs, which received FDA authorization on 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 per month.
OraSure aims to make 4 million tests per month by January and 8 million per month by June. It plans to scale up to 200 million 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, according to Gleason.
The View From the FDA
The FDA has authorized more than 400 COVID-19 tests, including at-home options and those processed by a medical provider or a lab. The agency is still getting more than 100 EUA submissions for COVID-19 tests per month, many from overseas. But, McKinney said, the vast majority aren’t for the type most needed now: tests for over-the-counter use.“If we did to antigen tests what happened with antibody tests, we would completely destroy the credibility of the test,” Aspinall said. “As frustrating as this is, I have to respect the FDA for ensuring that we continue to have quality tests.”
Nonetheless, the bottlenecks are felt by Americans trying to keep their employees and families safe.
“In order to test people twice a week on a regular basis for months on end, we need it to be, just the same as anyone, affordable,” Chang said.