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Unreliable antibody tests flood the market as FDA waives quality reviews



The current FDA commissioner, Stephen Hahn, told POLITICO that the agency has discussed changing the current policy, which allows manufacturers to validate the quality of their own products as long as they include a disclaimer with test results. The FDA is trying to balance concerns about quality with its desire to allow innovative tests to reach the market quickly during a pandemic, he said.

It is not clear how any changes to the agency’s existing policy would affect the more than 155 antibody tests now available.

The FDA formally warned health care providers April 17 of the concerns surrounding the bulk of the antibody tests available for sale, explaining that it “does not review the validation, or accuracy, data for these tests unless an EUA is submitted.”

Hahn told POLITICO that an emergency-use authorization “is the process that gives us confidence in a test.” It is still faster and less rigorous than securing FDA approval for a new diagnostic test. That process typically takes more than a year, from the initial test development to the agency’s final decision, and requires companies to submit significantly more data.

FDA observers say the weak standards for antibody tests appear to be a response to critics who said the agency was too slow to approve coronavirus diagnostic tests in the early months of the outbreak.

Former FDA lawyer Coleen Klasmeier said the agency swung too far the other way. She said FDA needs to set tougher quality standards for specificity — which measures how often a test correctly produces positive results — and sensitivity, which measures how often a test correctly produces negative results.

Another approach would be to require companies to regularly submit data to prove their tests are accurate, said Klasmeier, now a partner at the law firm Sidley Austin.

Scott Becker, the CEO of the Association of Public Health Laboratories, has criticized the FDA for allowing “crappy” antibody tests onto the market without adequate review. “Ideally they would scrap the current policy and start over, but I don’t think that’s practical given this crisis,” he said. “The best we can hope for is a rigorous and expansive evaluation.”

And that might be coming. The FDA recently launched a program with the Centers for Disease Control and Prevention, the National Cancer Institute and National Institutes of Health that allows test manufacturers to have their products independently assessed for accuracy.

FDA diagnostics chief Tim Stenzel said several companies are already participating. “We will make results known as soon as we find a way to do that,” Stenzel said on a webinar Wednesday. “We will just say that some of this information is proprietary.”

Stenzel also said the FDA has “nearly completed” a template to make it easier for antibody test developers to apply for an emergency use authorization. The template will set out some minimum standards for sensitivity and specificity, he added.

Efforts to improve antibody tests also got a boost from the coronavirus aid package signed into law Friday, which provides the NCI with $306 million to help develop, assess and improve the tests.

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