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FDA Revokes EUA for Chembio Dx Serology SARS-CoV-2 Test, Citing Performance Concerns

NEW YORK ─ The US Food and Drug Administration on Tuesday revoked its Emergency Use Authorization of Chembio Diagnostic's DPP COVID-19 IgM/IgG test because of concerns about its sensitivity and specificity.

The antibody test received EUA from the FDA in April but in a statement on Tuesday, the agency said that "data submitted by Chembio as well as an independent evaluation of the Chembio test at NCI showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device."

As a result, the FDA has decided it is unreasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that its known and potential benefits outweigh its known and potential risks. The risk to public health from incorrect test results makes EUA revocation appropriate, and the product may not be distributed, the agency added.

Shares of Chembio plummeted in Wednesday morning premarket trading on the Nasdaq by more than 61 percent at $3.87.

Antibody tests can help provide information on exposure to SARS-CoV-2, and Chembio's product was among the first such tests authorized by the FDA during the COVID-19 public health emergency.

To date, the FDA has issued 141 EUAs for tests to detect SARS-CoV-2. Of that 21 are for serology tests, including the original EUA issued for Chembio's test.

In a research note on Tuesday, Canaccord Genuity analyst Max Masucci noted that Chembio's DPP COVID-19 system was also granted EUA in April by Anvisa, Brazil’s regulatory authority, and was granted CE marking in early May, permitting its sale in European Union countries and others that accept the designation.

Though it is unclear whether the firm's CE mark or Brazilian approval will be revoked, the investment bank now expects $7.6 million in serology test revenues for Chembio in 2020, down from an earlier estimate of about $76 million, and $2 million in serology test revenues in 2021, down from a previous estimate of about $77 million. The revisions reflect the removal of the firm's antibody test from the US market, Masucci said.

In early March, Chembio had announced a worldwide partnership with private diagnostics company LumiraDx to develop point-of-care diagnostic tests for the detection of SARS-CoV-2 and IgM and IgG antibodies to the coronavirus that would run on both firm's diagnostic platforms.

"Following the FDA’s revocation of [Chembio's] antibody test, we find it less likely that the company can successfully develop a cartridge-based antibody test to be run on LumiraDx’s platform," Masucci said.

In a filing on Wednesday with the US Securities and Exchange Commission, Chembio said the FDA's letter to the firm stated that the agency had decided to revoke the EUA due to performance concerns "regarding the sensitivity and specificity of our test system." Chembio also said that it intends "to continue working with the FDA with respect to the modification of the DPP COVID-19 System and of the revocation of the EUA for our test system."