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Chembio to try again to win FDA approval for COVID-19 antibody test, executives say

A rapid test and results reader for the

A rapid test and results reader for the coronavirus from Chembio Diagnostics Inc., seen on March 22. Credit: Chembio Diagnostics Inc.

Chembio Diagnostics Inc. will try to regain the federal approval it lost for a coronavirus antibody test that was found to produce inaccurate results in some cases, executives announced on Monday.

They also said the Hauppauge manufacturer is developing a coronavirus antigen test that determines if a patient has the virus by detecting fragments of proteins found on or within the virus. The test involves samples collected from the nasal cavity using swabs.

The project has received $628,071 from the U.S. Department of Health.

The announcements follow last month’s decision by the federal Food and Drug Administration to revoke the Emergency Use Authorization, or EUA, granted to Chembio in April to sell its rapid test for coronavirus antibodies domestically. The FDA’s decision led to a sell-off of the company’s stock, with shares losing 61% of their value on June 18.

At the time, the FDA's chief scientist said the changes proposed by Chembio for its antibody test in May didn’t address the agency’s concerns about “the risks to public health from false test results.”

An FDA spokesman said last month the Chembio test is the first coronavirus antibody test to have its EUA revoked by the agency. The FDA has approved more than two dozen antibody tests. 

Antibodies are produced by the body to fight off infections; having coronavirus antibodies indicates a patient has successfully fought off the virus. While it’s still uncertain if those with antibodies are immune to the virus, false positive tests could give people a false sense of confidence.

Chembio CEO Rick Eberly said on Monday the antibody test “can add tremendous value in quickly evaluating” whether a patient has coronavirus antibodies. “We remain confident that the unique features and benefits of our test platform will make it one of the preferred solutions for antibody testing worldwide,” he said.

The company sold between $800,000 and $3.3 million of the antibody tests in the three months ended June 30, including $2.5 million overseas, it said Monday.

Eberly said additional changes had been made “to respond to the FDA’s new performance criteria, as well as the rapidly evolving scientific and clinical understanding of the virus that led to the adoption of those criteria.”

Chembio’s inability to sell the antibody test since June 16 disrupted the company’s multimillion expansion plan to convert all its production lines to making the test. They had been turning out tests for HIV, syphilis, Ebola, Zika and other infectious diseases in Hauppauge, Medford and in Brazil.

Chembio raised about $30 million in a May stock offering to hire more employees, make changes to assembly lines and close a factory in Malaysia. The company was sued by investors when shares plummeted after it lost FDA permission to sell the antibody test.

The announcements came after the stock market closed on Monday. The firm's shares closed Tuesday at $3.81; they were $15.24 on April 24, days after the antibody test first won FDA approval.

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