While developing a rapid test that detects the coronavirus in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration had more than 3,000 emergency use authorization applications and didn’t have the resources to get through them.
“We want to try to avoid the EUA quagmire,” said Peb Hendrix, the startup’s vice president of operations. Its test is still in early development. On the advice of consultants, the company is 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 U.S. 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 they are widely available in Europe. Experts say the paucity of tests and their high prices undermine efforts in the U.S. to return to normal life.
Some experts say 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 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.
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 supply of rapid tests, but public health and industry experts say 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, a co-founder of life sciences fund BlueStone Venture Partners and a board member for OraSure Technologies, which 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 says it is 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 a day, McKinney said, adding that it would “efficiently review the submissions that will have the biggest impact on the nation’s testing needs.”
In addition to the slow pace of approvals, manufacturing bottlenecks created by materials and labor shortages are keeping prices high. Prices of rapid tests range from $14 for a two-pack to well over $50 a test, far from affordable for regular use.
The FDA says 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.