A Hauppauge manufacturer has lost federal permission to sell its new coronavirus antibody test because of inaccurate results in some instances, officials said.
Chembio Diagnostics Inc. announced Wednesday that the Food and Drug Administration has revoked the Emergency Use Authorization granted to the company in April to sell its rapid test for the antibodies domestically.
“As a result of this decision by the FDA, we may no longer distribute the DPP COVID-19 system,” CEO Richard Eberly said in a securities filing. "We intend to continue working with the FDA with respect to the modification" of the test.
However, FDA chief scientist Denise M. Hinton said on Tuesday the changes proposed so far by Chembio don't address the agency's concern about "the risks to public health from false test results."
In a letter, Hinton said, "Given the poor device performance observed in multiple evaluations since the authorization [was issued], FDA has concluded it is not reasonable to believe the product may be effective in detecting antibodies against [the coronavirus]."
Antibodies are produced by the body to fight off infections; having coronavirus antibodies indicates a person 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.
An FDA spokesman said Wednesday the Chembio test is the first coronavirus antibody test to have its Emergency Use Authorization, or EUA, revoked by the agency.
A Chembio spokesman did not respond to a request for comment. The FDA’s decision upends the company's multimillion-dollar expansion plan to convert all its production lines to making the antibody test. They have been turning out tests for HIV, syphilis, Ebola, Zika and other infectious diseases in Hauppauge, Medford and in Brazil.
Chembio shares plummeted on the news, closing down $6.04, or nearly 61%, to $3.89 on the NASDAQ stock market.
Hinton, the FDA scientist, said the agency authorized the Chembio test for sale based on research provided by the company that showed the test "may be effective," which is the criteria for issuing an EUA. However, subsequent evaluations of the test by the National Cancer Institute and others found "significant performance concerns with your device, which may put patients at unreasonable risk of harm due to inaccurate results."
FDA first raised its concerns about the Chembio test on April 29 and the company responded with more research data on May 15 and May 24. The May 24 information included a change in research criteria, which FDA officials said represents an unacceptable change in the company's EUA application.
"Chembio has not requested and FDA has not concurred on any such changes to the scope of authorization," Hinton said.
While the FDA and Chembio were debating research data, the company embarked on a plan to produce 1 million coronavirus antibody tests in May and up to 2 million by September. It won a $1 million grant from New York State and raised $31 million in a stock offering. The funding was to hire more employees, make changes to assembly lines and close a factory in Malaysia.
Stony Brook University purchased the test for a 500-person study to see if the blood of coronavirus survivors can help those critically ill with the virus. A university spokeswoman did not respond to a request for comment.
Patients typically develop antibodies to the coronavirus in one to three weeks after infection, according to the Centers for Disease Control and Prevention.
Medical professionals remain cautious about the level and length of protection that antibodies offer after recovering from the virus.
“It could be weeks, months, years,” said Dr. Anthony Harris, medical director of WorkCare, an Anaheim, California, company that consults with businesses on the pandemic. “What we do know is the likelihood of contracting COVID-19 after recovering from it is not as great as if you’ve never had it.”
CORRECTION: An earlier version of this story described the Chembio tests incorrectly.
Diagnostic test vs. antibody test
Unlike the molecular tests used to diagnose a patient stricken by the coronavirus, antibody tests are used to determine whether someone previously had 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.
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