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antibody-based diagnostics

The test leverages ELISA technology and uses non-pathogenic viral proteins, enabling its use in common lab settings either manually or automatically.

The firm said the new contract will provide funding to support the production of up to 6.7 million COVID-19 antigen and antibody tests per month for the US market.

iAssay plans to evaluate a COVID-19 incorporating each firm's technology in support of a submission to FDA for possible Emergency Use Authorization.

Quidel's guidance announcement cited an approximately 40 percent decrease in demand for its SARS-CoV-2 tests.

LightDeck said it is developing a six-minute test to offer better performance than current lateral flow tests that need 15 minutes or more to return a result.

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.