antibody-based diagnostics

The firm plans to begin its OTC efforts with a COVID antigen test but also sees potential in migrating other infectious disease tests.

The EUA for the antibody test follows funding that Quanterix received recently from BARDA for the development of a SARS-CoV-2 antigen test.

Unlike the firm's Sofia system, the QuickVue line does not require a reader instrument but is instead visually read.

On its weekly call, the agency also stressed the importance of reporting test results, including those from home-based tests, to public health authorities.

The agency said review of Chembio's EUA request was not a priority because it would have a limited impact on testing capacity.

Ginkgo will offer Access Bio's antigen tests through its Concentric by Ginkgo service.

According to some analysts, the selloff in IVD company shares may be an overreaction, and SARS-CoV-2-related testing will be needed for some time in the future. 

The quantitative kit applies a recombinant S1 subunit of the coronavirus spike protein to detect IgG antibodies against the coronavirus.

The firm submitted a new Emergency Use Authorization application to the FDA for a serology IgM/IgG test for SARS-CoV-2 after the agency revoked an earlier EUA for a similar test.