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LI firm wins $12.7M contract for COVID test despite FDA pulling previous test for inaccuracies

Chembio researchers perform a coronavirus test in the

Chembio researchers perform a coronavirus test in the company's Long Island laboratory.  Credit: Chembio Diagnostics Inc.

A Hauppauge manufacturer has won a federal contract to develop an antigen test for COVID-19 and influenza after losing federal permission to sell a COVID antibody test in June.

Chembio Diagnostics Inc. said it has been awarded $12.7 million from the U.S. Department of Health and Human Services’ Biomedical Advanced Research & Development Authority, or BARDA, to develop the COVID/influenza antigen test and to seek emergency authorization from the U.S. Food and Drug Administration for sales in the current flu season.

The 20-minute test would determine if a patient has the COVID virus by detecting fragments of proteins found on or within the virus. It also would be capable of detecting influenza A and B simultaneously, using a nasal or nasopharyngeal swab.

"We believe rapid, point-of-care tests can improve clinical outcomes and play a major role in combating this ongoing pandemic, especially during the upcoming flu season," CEO Richard Eberly said last week. He said the company has worked with BARDA previously.

Chembio’s pursuit of federal approval for the COVID antigen test follows the removal of its COVID antibody test from the U.S. market in mid-June because the FDA revoked the Emergency Use Authorization, or EUA, granted in April. Regulators found the antibody test produced inaccurate results in some cases.

Antibody tests check patients' blood for antibodies, which can show if they had a past infection with the virus that causes COVID-19.

Chembio has since made changes to the antibody test and in September applied again for an EUA. However, last week the FDA told the company it wouldn’t immediately review its application, according to a securities filing.

The FDA determined that review of the request "is not a priority because, for example, authorization of the test would have relatively limited impact on testing accessibility or testing capacity," the filing states.

Chembio had planned to stop production of its tests for HIV, syphilis, Ebola, Zika and other infectious diseases in order to make the antibody test in large quantities.

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