Providers, consumers gain more clarity on antibody testing from FDA

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Lisa LaMotta Editor-in-Chief, Risk & Regulatory, PwC US May 28, 2020

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After months of easing regulations, the FDA has published a list of companies producing antibody tests for COVID-19 that are no longer backed by the agency, giving the public a bit more transparency into a saturated market. 

The list, updated on May 22, is part of an updated FAQ section the FDA has been compiling since the beginning of the pandemic. As of May 21, it includes tests from 29 companies—largely from the US and China. Those on the list have been voluntarily withdrawn from the market or have not been issued an Emergency Use Authorization (EUA). The FDA expects that none of these tests will be marketed or distributed.

“With this action today, the FDA continues to carry out its mission to protect the public health and safety of consumers. FDA is committed to providing timely information to the American public as part of the agency’s effort to combat this pandemic,” the agency said in a statement.

Serology tests measure the level of antibodies against a certain pathogen, in this case, SARS-CoV-2, the virus that causes COVID-19. The presence of antibodies indicates that an individual may have been exposed to the virus. It remains unknown whether antibodies against SARS-CoV-2 protect a person from being reinfected and, if they do, for how long.

In March, the FDA allowed commercial manufacturers and laboratories to develop antibody tests without prior authorization from the agency as long as they were validated and the company notified the agency ahead of commercial marketing. More than 100 tests soon flooded the market, raising questions about quality (see HRI’s report).

On May 4, the FDA revised its guidance, requiring commercial manufacturers of the serology tests to seek an EUA within 10 days that included validation. Laboratories are encouraged to seek an EUA but can develop and use a serology test to identify antibodies of SARS-CoV-2 if the labs are certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing, the test has been validated, the FDA has been notified, and certain measures are taken to help patients understand the results. Only 17 labs have been put on this list.

HRI impact analysis

Several government agencies, including the FDA and HHS, rapidly deregulated in the face of the pandemic. While many of the eased restrictions are meant to be in place only for the length of the health emergency, some will likely endure.

In the case of serology testing, the FDA began with a hands-off approach, but has had to pull back several times in order to regulate quality and accuracy. (See here.)

The tests have become of increasing importance as many states begin to ease stay-at-home orders to reopen the economy. Access to serology tests can give government officials a better understanding of how much of the local population has already been exposed to the virus, but may have not been given a diagnostic test during the early parts of the crisis.

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Senior Manager, Health Research Institute, PwC US

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