UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date of Report (Date of earliest event reported):
December 1, 2021
CHEMBIO DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
Nevada
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0-30379
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88-0425691
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(State or Other Jurisdiction of Incorporation or
Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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555 Wireless Blvd.
Hauppauge, NY 11788
(Address of principal executive offices) (Zip code)
Registrant’s telephone number, including area code:
(631)
924-1135
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol
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Name of each exchange on which registered
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Common
Stock, $0.01 par value
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CEMI
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The NASDAQ Stock Market LLC
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 or
Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
Request for Additional Data Related to CLIA Waiver Submission for
DPP
HIV-Syphilis Test System
On December 1, 2021, we received notice from the U.S. Food and
Drug Administration, or FDA, that the FDA would require additional
data related to our Clinical Laboratory Improvement Amendment, or
CLIA, waiver submission for the DPP HIV-Syphilis test system. We
are in active discussions with the FDA in connection with the FDA’s
review of our submission and we intend to seek to comply with the
FDA’s request for additional data, but the process of seeking
additional data will extend, for a currently undeterminable period,
our process for seeking a CLIA waiver for the DPP HIV-Syphilis test
system. We cannot assure you that we will be able to compile the
additional data requested by the FDA in a timely manner or at all,
and therefore we cannot assure you that a CLIA waiver will be
granted with respect to the DPP HIV-Syphilis test system at any
specific time in the future or at all.
Scheduled Expiration of BARDA Agreement
Our contract, which we refer to as the BARDA Agreement, dated
December 2, 2020 with the Biomedical Advanced Research and
Development Authority, or BARDA (part of the U.S. Department of
Health and Human Services’ Office of the Assistant Secretary for
Preparedness and Response), expired in accordance with its terms on
December 2, 2021. Under the BARDA Agreement, up to $12.7 million of
awards were available from BARDA in order to assist us in
(a)
developing, and requesting an EUA from the FDA for, the DPP
Respiratory Panel and (b) performing the clinical trials for and
submitting the DPP SARS‑CoV‑2 Antigen test system to the FDA, for
510(k) clearance.
As of September 30, 2021 we had earned a total of $9.6 million in
grant income under the BARDA Agreement, and from October 1, 2021
through December 2, 2021 we earned an additional $2.9 million of
grant income under the BARDA Agreement. As a result, we earned
$12.5 million of the $12.7 million available under the BARDA
Agreement, with the remaining $0.2 million having not been earned
because it was contingent on our receiving an emergency use
authorization for the DPP Respiratory Panel by December 2,
2021.
SIGNATURE
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.
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Chembio Diagnostics, Inc.
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Dated: December 8, 2021
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By:
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/s/ Richard L. Eberly
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Chief Executive Officer and President
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