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Chembio Diagnostics

The firm said it has licensed an instrument-free rapid immunoassay from an undisclosed test manufacturer that has received FDA Emergency Use Authorization.

News items for the in vitro diagnostics industry for the week of March 15, 2021.

The firm plans to expand the menu for its immunoassay reader, anchoring its US expansion to a novel dual test for HIV and syphilis.

The firm recently in-licensed distribution of an Emergency Use Authorized SARS-CoV-2 antigen assay it expects to launch in March 2021.

The company continues to face regulatory challenges in the US, but received CE marking for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems.

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

The firm said that part of the funding will support the development of a rapid, multiplex DPP Respiratory Antigen Panel for the upcoming flu season.

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.