CODX Co Diagnostics Inc

 

 

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): February 21, 2025

 

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 February 21, 2025, Co-Diagnostics, Inc. issued a press release providing an update on its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™. 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

 

Exhibit No.:		Description:
99.1		Press Release, dated February 21, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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: February 21, 2025	By:	/s/ Brian Brown
	Name:	Brian Brown
	Title:	Chief Financial Officer
		(Principal Financial and Accounting Officer)

 

 

 

Exhibit 99.1

 

 

Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance

 

The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component

 

Salt Lake City, Utah – February 21, 2025 – Co-Diagnostics, Inc. (Nasdaq-CM: 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, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k) clearance.

 

Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument.

 

The decision by the Company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process.

 

The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform.

 

The Company’s primary objective is to execute a robust development and commercialization plan for the Co-Dx PCR platform, including ongoing innovations to the PCR Pro instrument. The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others.

 

*The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.

 

 

 

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. Forward-looking statements include statements made with respect to timing for submission of the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, that streamlining the COVID-19 test will also help to create greater operational and manufacturing efficiencies, and our expectation that additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others, will follow. 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 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

 

 

v3.25.0.1

Cover	Feb. 21, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 21, 2025
Entity File Number	1-38148
Entity Registrant Name	CO-DIAGNOSTICS, INC.
Entity Central Index Key	0001692415
Entity Tax Identification Number	46-2609363
Entity Incorporation, State or Country Code	UT
Entity Address, Address Line One	2401 S. Foothill Drive
Entity Address, Address Line Two	Suite D
Entity Address, City or Town	Salt Lake City
Entity Address, State or Province	UT
Entity Address, Postal Zip Code	84109
City Area Code	(801)
Local Phone Number	438-1036
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CODX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

---