Congress last week allocated $25 billion to expand access to COVID-19 diagnostic tests as the FDA continues to pull out all the stops to get tests to the marketplace via Emergency Use Authorizations (EUAs) that exempt devicemakers from liability for product failures.
As of April 23, the FDA had approved 62 diagnostics tests, including four antibody tests, according to Commissioner Stephen Hahn.
“These test are being developed in weeks. We have the validation data and we approve them when the validation suggests that they are reliable, accurate and reproducible,” Hahn said in a CNN coronavirus town hall.
“But we know that we’re going to get feedback when they go out into the field, we’re going to get feedback on how they operate in the real world. They may be used in conditions that were not originally tested.”
Hahn said the agency will adjust its authorizations based on the new data.
The FDA said that, for a “reasonable period of time after validation” and while the agency is reviewing EUA requests, it does not intend to object to the use of these tests, noting that 15 days is a reasonable timeframe to prepare an EUA submission for a test that has already been validated.
“In the context of a public health emergency involving pandemic infectious disease, it is critically important that tests are validated, as false results can have broad public health impact beyond that to the individual patient,” the agency said.
Reps. Rosa DeLauro (D-Conn.) and Lloyd Doggett (D-Texas) wrote a letter to Hahn early this month, citing errors in the first emergency use test the agency authorized, which was developed by the Centers for Disease Control and Prevention.
“Despite clear evidence that the test was fatally flawed, the administration continued to rely on that inaccurate test for three weeks,” the lawmakers wrote. “This troubling and unjustified delay contributed greatly to the spread of the novel coronavirus in February and March, when those who were infected were not accurately identified and quarantined.”
“The issue with the tests for the SARS-CoV-2 virus is that there has not been time to test them rigorously before deploying them in the field,” said Gary L. LeRoy, president of the American Academy of Family Physicians. “Most polymerase chain reaction and antibody tests have years of laboratory testing before they are used. We just don’t have that kind of time.”
Researchers at the Cleveland Clinic tested five of the most commonly used coronavirus tests — including Abbott’s 15-minute ID NOW test — and found a false-negative rate of 14.8 percent using the Abbott test. The company attributed the problem to sample storage prior to testing and said users should only test samples put directly into the testing machine.