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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): June 14, 2024
CO-DIAGNOSTICS,
INC.
(Exact
name of small business issuer as specified in its charter)
Utah |
|
1-38148 |
|
46-2609363 |
(State
or other jurisdiction of |
|
(Commission |
|
(IRS
Employer |
incorporation
or organization) |
|
File
Number) |
|
Identification
Number) |
2401
S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address
of principal executive offices)
(801)
438-1036
(Issuer’s
telephone number)
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:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
CODX |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item
8.01 Other Events.
On
June 14, 2024, Co-Diagnostics, Inc. issued a press release announcing that it had submitted to the FDA a 510(k) Application for the Co-Dx™
PCR Pro™ Platform. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, hereunto duly authorized.
|
CO-DIAGNOSTICS,
INC. |
|
|
|
Date:
June 14, 2024 |
By: |
/s/
Brian Brown |
|
Name: |
Brian
Brown |
|
Title: |
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1692415/000149315224023796/ex99-1_001.jpg)
Co-Diagnostics,
Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform
The
Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the
pipeline to meet the needs of a global market
Salt
Lake City, Utah – June 14, 2024 – Co-Diagnostics, Inc. (Nasdaq: CODX) (the “Company” or “Co-Dx”),
a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that
the Company has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx™ PCR
Pro™ instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.
Co-Diagnostics
completed the submission via the FDA’s electronic Submissions Template And Resource (eSTAR) system, and have received the acknowledgement
from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize
and consolidate the necessary information and links needed for 510(k) submission preparation.
The
Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization
of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories. It consists of a
compact and robust real-time PCR instrument operated at point-of-care or in at-home settings via an intuitive smartphone interface, with
test cups powered by patented Co-Dx Co-Primers® technology.
The
Company is also preparing to shortly pursue clearance for the Co-Dx PCR COVID-19 test on the new instrument, to be used for point-of-care
testing (POCT).
Other
diagnostics for the platform in varying stages of development or preparation for clinical evaluations include tests for tuberculosis,
human papillomavirus, strep A, and a respiratory multiplex that detects influenza A and B, COVID-19 and RSV in a single test.
“This
FDA application is an important milestone in our Company’s growth and represents a crucial step towards closing the gap that separates
many patients and communities around the world from gold-standard diagnostics,” said Dwight Egan, Company CEO. “If granted,
we believe that the credibility of 510(k) clearance for diagnostic use would greatly validate the quality of our new platform as we proceed
with the completion of tests for other indications and for use in other regions of the world.
“While
we have identified markets for this initial diagnostic offering and we are eager to begin commercialization once cleared to do so, we
expect that the other tests to follow will be even more transformative, and we are quickly moving to complete the requirements to initiate
clinical evaluations and submit regulatory filings for these tests in their respective target markets.”
*The
Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the
FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently
under review by the FDA.
![](https://www.sec.gov/Archives/edgar/data/1692415/000149315224023796/ex99-1_001.jpg)
About
Co-Diagnostics, Inc.:
Co-Diagnostics,
Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies.
The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules
(DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform
and to locate genetic markers for use in applications other than infectious disease.
Forward-Looking
Statements:
This
press release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,”
“expects,” “estimates,” “intends,” “may,” “plans,” “will” and
similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist
at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include
statements concerning our intention to pursue clearance for POCT use of the COVID-19 test kit on the new instrument in the near future,
and our plans to begin clinical evaluations and complete regulatory submissions for the other tests in our pipeline. Forward-looking
statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those
contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance
on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all
due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form
10-K, filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Company does
not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may
be required by applicable securities laws.
|
Company
Contact: |
Media
Contact: |
|
Andrew
Benson |
Jennifer
Webb |
|
Head
of Investor Relations |
ColtrinMethod
PR |
|
+1.801.438.1036 |
jcoltrin@coltrinmethodpr.com |
|
investors@codiagnostics.com |
|
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