- May 12, 2020
Under its original policy, FDA said it would not object to the development and use of serological tests without FDA review or authorization so long as the tests were validated and the agency had been notified that the company planned to market the tests. More than 100 antibody tests were marketed under the initial policy. The policy change comes after reports emerged questioning the accuracy of some of the tests on the market and an investigation by Democrats on the House Oversight Subcommittee on Economic and Consumer Policy.
The revised policy also comes less than a week after FDA issued an umbrella EUA for COVID-19 antibody tests that have undergone independent validation by the National Cancer Institute (NCI) or other government agencies. FDA has now issued EUAs for a dozen antibody tests for COVID-19, with most of the EUAs being granted in the last two weeks, and has received validation data from NCI for 13 test kits. “When we issued our original serologic test policy in mid-March, it was critical for the FDA to provide regulatory flexibility for serologic test developers given the nature of this public health emergency and an understanding that the tests were not to be used as the sole basis for COVID-19 diagnosis,” said FDA Commissioner Stephen Hahn.
Now, FDA says commercial manufacturers must submit an EUA within 10 business days that includes validation data for the tests and warns that it will publicly disclose the names of companies that fail to do so.
In its updated guidance, FDA also provides performance threshold recommendations for specificity and sensitivity for antibody tests as well as voluntary templates for manufacturers and laboratories to follow when submitting EUAs. Hahn said the new templates will help streamline the EUA process for antibody tests.
REFERENCE: RAPS; Regulatory Focus; 04 MAY 2020; Michael Mezher