FDA changes policy, requires manufacturers to submit antibody test data

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Commercial manufacturers will now be required to submit data to the Food and Drug Administration (FDA) proving the accuracy of their antibody tests, a reversal of a previously controversial agency policy.

Under the new policy, announced Monday, manufacturers must apply for an emergency use authorization, with their validation data, within 10 business days from the date their products are available. 

If commercial manufacturers that are currently marketing tests fail to apply for the approvals, the FDA said it intends to share that information publicly. 

The agency also provided specific performance threshold recommendations regarding specificity and sensitivity for all test developers. Specificity measures how often the tests produce a correct positive result, while sensitivity measures how often the test shows a correct negative result. 

Antibody tests have been heralded by state and federal leaders who hope they can help guide decisions about when and how to reopen the country by identifying who has been exposed to the virus and may now have immunity even if they have never been diagnosed.

COVID-19 has killed nearly 70,000 people and sickened more than 1.1 million in the United States alone.

But in the rush to get tests to the public quickly, the FDA allowed companies to market tests with little to no oversight, raising the potential for a surge in inaccurate results. The original policy, which allowed companies to self-verify their tests, had been in place since mid-March.

The agency’s change comes after an investigation by the House Oversight and Reform Committee found more than 150 tests were being marketed to customers without any FDA review, compared with only 11 that have been authorized to date, many within the past few days. 

Many of the unauthorized tests had high rates of false positives, which could mislead people into thinking they have already been infected when they have not.  

Some test developers falsely claimed their antibody tests are FDA approved or authorized. Some companies even falsely claimed the antibody tests could be used to diagnose COVID-19.

In a blog post Monday, FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah and Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, said the original policy was necessary to provide flexibility in a public health emergency.

“However, flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” they wrote.

Shah and Shuren added that a National Institutes of Health evaluation also found “a concerning number” of commercial antibody tests are “performing poorly.”

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