Devices

FDA Tightens Antibody Test Requirements

Faced with the problem of allowing about 200 Covid-19 serology (antibody) tests on the market without normal vetting or reviews, FDA 5/4 tightened expectations for antibody test developers to market such tests. Based on a lack of testing at the beginning of the pandemic, the agency had relaxed its policies in March to allow serology tests to enter the market with virtually no vetting. Reliability concerns and questionable marketing quickly followed, and FDA now finds itself with a large problem to address (see earlier story). Last month, FDA said it was considering tougher requirements on antibody tests during a briefing before House Oversight Committee staff.

Under the revised policy, according to an agency release, the following are expectations for antibody test developers:

Commercial manufacturers will submit emergency use authorization (EUA) requests, with their validation data, within ten business days from the date they notified the FDA of their validation testing or from the date of the new policy, whichever is later.
specific performance threshold recommendations are being provided for specificity and sensitivity for all serology test developers.

FDA says it is still continuing to encourage all test developers to submit EUA requests so it is able to examine data on each test’s performance and make an emergency use determination. To date, the agency says just 12 antibody tests have been authorized under an individual EUA, most within the past few days, and over 200 antibody tests are currently the subject of a pre-EUA or complete EUA review.

FDA is also working with the National Institutes of Health, the Centers for Disease Control and Prevention, and the Biomedical Advanced Research and Development Authority to establish a capability at the National Cancer Institute (NCI) to independently validate certain antibody tests, including antibody tests that were not the subject of an EUA or pre-EUA, as well as those that were under FDA review. “The FDA can use the NCI data to inform future decision making, such as whether to authorize the test, guide us in engaging the test developer for additional information to support its test remaining on the market, or take other action regarding tests that do not perform adequately, including to stop their marketing in the U.S.,” the release says. NCI has shared validation data from 13 test kits so far with the agency, and the results will be publicly available once it has reviewed and determined if any further actions are appropriate for those test kits prior to publication.

Additionally, FDA says it is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests have been made available – one for commercial manufacturers, and one for CLIA-certified high-complexity labs who decide to seek FDA authorization.

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