FDA creates umbrella emergency pathway for Covid-19 serology tests
The FDA has created a new pathway to support the emergency authorization of tests for antibodies of the virus that causes COVID-19.
Serology tests could play an important role in the safe lifting of lockdowns by enabling authorities to identify individuals with antibodies of the SARS-CoV-2 virus and calculate what proportion of a population has already been infected. The pathway unveiled by the FDA on Wednesday gives test developers a new route to an emergency use authorization (EUA).
The new route, described by the FDA as an “umbrella” EUA, will enable serology tests to be marketed after being put through an independent validation study at the National Cancer Institute or another designated government agency. The FDA also will need to confirm a test meets the criteria outlined in its Scope of Authorization.
In the Scope of Authorization, the FDA set out the validation process. The FDA-designated laboratories will use the tests to analyze 30 or more samples known to contain SARS-CoV-2antibodies, as well as 80 without.
To pass, a test must achieve a sensitivity or 90% and specificity of 95% for IgG and IgM antibodies. That benchmark is in line with the performance of diagnostics authorized so far under the EUA pathway.
Developers of diagnostics that meet all the performance criteria must include certain information on the product label. The FDA expects devices cleared under the umbrella pathway to ship with detailed instructions for performing the test and analyzing its results, as well as a warning about the risk of false positives.
The creation of the pathway comes amid scrutiny of the FDA’s approach to the availability of serology tests. To date, the FDA has granted EUA to serology tests manufactured by eight companies. More organizations have made serology tests available without securing EUA by taking advantage of the Policy D pathway. The pathway permits manufacturers to start marketing tests after validating their performance and notifying the FDA.
Rep. Raja Krishnamoorthi (D-IL), the chairman of the House Subcommittee on Economic and Consumer Policy, has criticized the FDA for offering test developers that flexibility, arguing in a letter to FDA Commissioner Stephen Hahn abdigating “responsibility [to protect the public health] and trusting private industry to regulate itself is unacceptable.”
Krishnamoorthi’s concerns were based in part on non-peer-reviewed research published on the medRxiv pre-print server that noted “heterogenous assay performance,” leading the House subcommittee to also write to four of the companies that sell tests assessed by the researchers.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.