Washington, D.C. 20549


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 16, 2020

(Exact name of registrant as specified in its charter)

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555 Wireless Blvd. Hauppauge, NY 11788
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Item 8.01
Other Events.

On June 16, 2020, we received a letter from the U.S. Food and Drug Administration, or FDA, notifying us that the FDA was revoking the Emergency Use Authorization, or EUA, granted in April 2020 with respect to our DPP COVID-19 System, which consists of our serological test for COVID-19 and one of our Micro Reader analyzers. As a result of this decision by the FDA, we may no longer distribute the DPP COVID-19 System.

The DPP COVID-19 System was one of the first antibody tests authorized by the FDA during the COVID-19 public health emergency. Based on the information that we submitted to the FDA at the time of authorization, the FDA concluded that our test system met the applicable “may be effective” standard for an EUA.

In its letter of June 16, 2020, the FDA stated that it had decided to revoke the EUA for the DPP COVID-19 System due to performance concerns regarding the sensitivity and specificity of our test system. According to the FDA, an independent evaluation of our test system by the National Institutes of Health’s National Cancer Institute, as well as other independent evaluations, showed (a) our test system generated a higher rate of false results than expected under our initial EUA request and our authorized labeling and (b) it is not reasonable to believe that our test system may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of our test system outweigh its known and potential risks.

We intend 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.


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be filed on its behalf by the undersigned hereunto duly authorized.

Chembio Diagnostics, Inc.
Dated:  June 17, 2020
/s/ Richard Eberly
Chief Executive Officer and President