FDA Pulls Emergency Use Authorizations for Two Quanterix COVID-19 Tests

The FDA announced that it revoked Emergency Use Authorization (EUA) for Lexington, Mass.-based Quanterix’s Simoa semi-quantitative SARS-CoV-2 IgG antibody test and the Simoa SARS-CoV-2 N protein antigen test.

Quanterix had requested a withdrawal of the EUAs in early May, noting that it had not distributed the antibody test in the U.S. and had discontinued distribution of the antigen test. The company said no viable tests remained in distribution.

The FDA granted the EUA for the Simoa antibody test on Dec. 23, 2020, and an EUA for the Simoa antigen test on Jan. 5, 2021.

In a June 27 notice, the agency said it had revoked EUAs for both tests on May 10.