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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.
Following FDA's revocation of the firm's antibody-based test for the coronavirus in June, Chembio is seeking new EUAs for an antibody and antigen test for SARS-CoV-2.
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.
The single-use, multiplex immunoassay provides results in 15 minutes and detects antibodies to HIV types 1 and 2 as well as Treponema pallidum.
While the market ditched shares of many other diagnostics firms, analysts said the reaction was overblown, particularly in the case of Quidel and molecular diagnostics players.
The firm said that its financial results for the second quarter of 2020 reflected the impact of an FDA revocation of an EUA for its DPP COVID-19 IgM/IgG System.
Horiba received clearance for its Yumizen C1200 CRP reagent used to measure C-reactive protein for evaluation of infections, tissue injury, and inflammatory disorders.
The FDA recently revoked an EUA for Chembio's DPP COVID-19 IgM/IgG system, but the firm said that outside the US, it continues to ship the test and pursue additional opportunities.
Chembio suggested a device modification could improve performance, following an analysis of troubling NCI data. The FDA didn't agree.
The warning letters may signal increased vigilance from the FDA against firms offering coronavirus antibody tests that it believes could harm consumers.