Agency Draws a New Line on SARS-CoV-2 Antibody Serology Tests

It took a while but the FDA has finally come to the realization that letting blood-based serology tests for detection of SARS-CoV-2 antibody tests into the U.S. market without requiring test makers to prove the value of their products was a bad idea. And now the agency is walking back the policy, at least in part.

The Umbrella Pathway

After producers disregarded recommendations to do so voluntary, the FDA decided to require serology test makers to submit their products to federal labs for independent evaluation. The new “umbrella” pathway, which the agency unveiled on April 29, calls for an interagency testing group at the National Cancer Institute to assess the approximate specificity, sensitivity and overall predictive value of submitted tests  against a panel of samples confirmed positive for anti-SARS CoV-2 IgM and IgG antibodies, as well as against confirmed antibody negative samples or pre-COVID-19 samples, with 10 of these 80 negative samples being HIV positive. To pass:

• Tests reporting on both IgM and IgG must show 90% overall sensitivity and 95% specificity;
• Tests reporting the immunoglobulins separately must have 70% sensitivity for IgM and 90% for IgG; and
• Tests must show no cross-reactivity with HIV.

FDA Delists 27 SARS-CoV-2 Serology Assays

The new evaluation process and standards apply to all serology SARS-CoV-2 assays, including the purported gold standard tests that received Emergency Use Authorization (EUA) under Policy C. But on May 4, the FDA put an end to its controversial Policy D, the less rigorous pathway allowing test makers to introduce their products immediately upon internal validation without seeking EUA clearance. All the test maker had to do was notify the agency in an email listing cursory validation data and product labeling. From now on, all SARS-CoV-2 serology kits will require EUA.

And now the FDA is peeling back the roster of tests that came through Policy D. Of the approximately 214 serology test kits previously listed as allowed for U.S. distribution under Policy D, 27 have been removed for failing to meet the new Umbrella pathway standards or submit the data necessary to perform the independent evaluation, including nine products that were withdrawn voluntarily. Most of the removed tests are manufactured overseas but the list also includes tests made by: 

• Vita Testing (based in Beverly Hills);
• Diazyme Laboratories, a subsidiary of defense contracting giant General Atomics;
• Pharmatech, which was acquired by Caris Life Sciences last year; and
• BioMedomics, which developed a rapid fingerstick test formerly sold by Becton Dickinson.

Here are some of the key new FDA clearances announced in May:

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Other international clearances announced during the period: