Form 8-K

8-K — Co-Diagnostics, Inc.

Accession: 0001493152-26-042844

Filed: 2026-09-16

Period: 2026-09-16

CIK: 0001692415

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

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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): September 16, 2026

CO-DIAGNOSTICS,

INC.

(Exact

name of registrant as specified in its charter)

Utah

001-38148

46-2609363

(State

or other jurisdiction

incorporation)

(Commission

File Number)

(IRS

Employer

Identification

No. )

2401

S. Foothill Drive, Suite D, Salt Lake City Utah 84109

(Address

of principal executive offices) (Zip Code)

(801)

438-1036

Registrant’s

telephone number, including area code

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 ☐

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.

Press

Release

September 16, 2026, Co-Diagnostics, Inc. (the “Company”), issued a press release with respect to its collaboration with ReadyGo

Diagnostics Ltd. 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 September 16, 2026.

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:

September 16, 2026

By:

/s/

Dwight Egan

Name:

Dwight

Egan

Title:

Chief

Executive Officer

(Principal

Executive Officer)

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Co-Diagnostics and ReadyGo Collaborate

to Evaluate Blood-Based Molecular Testing at the Point of Need, Starting with Ebola

Blood-based testing could open new markets for

the Co-Dx® PCR platform, including HIV and hepatitis B and C

Co-Diagnostics and ReadyGo target decentralized

Ebola detection as the first application of their collaboration

Combining GoCollect® sample preparation with

Co-Dx PCR technology could bring blood-based molecular testing closer to patients

Company to hold in-person press conference and live

webcast today at 10:30 a.m. ET

SALT LAKE CITY, Utah, Sept. 16, 2026 — Co-Diagnostics,

Inc. (Nasdaq: CODX) (“Co-Dx” or “the Company”), a molecular diagnostics company with a unique, patented

platform for the development of molecular diagnostic tests and ReadyGo Diagnostics Ltd. (“ReadyGo”), a UK-based developer

of field sample-preparation technology, today announced that the companies are collaborating to evaluate the potential use of ReadyGo’s

sample-preparation technology with the Co-Dx PCR platform for blood-based molecular testing at the point of need, with an initial focus

on decentralized Ebola virus detection and outbreak response (the “Collaboration”). Establishing blood as a compatible sample

type would extend the Co-Dx PCR platform beyond the swab-based testing it supports today and into a broad category of bloodborne pathogens

that swab sampling cannot reach.

The companies are evaluating two potentially complementary

technologies: the Co-Dx® PCR platform*, a point-of-need PCR technology; and GoCollect® by ReadyGo, a field sample-preparation

system that prepares blood samples for molecular testing at the point of need. The collaboration will assess whether the technologies

can operate together as part of a streamlined workflow that prepares the sample, detects the virus, and supports the outbreak response

as one connected approach. The collaboration builds on Co-Dx’s earlier proof-of-concept work testing an Ebola assay using plasma

as a sample type.

“From the beginning, our objective has been

to make molecular testing accessible to patients in settings with limited laboratory infrastructure,” said Dwight Egan, Chief Executive

Officer of Co-Diagnostics. “Preparing a blood sample for testing in those settings is an important part of that challenge, and ReadyGo

brings technology that we believe could help us address it. This work with ReadyGo builds on our earlier work with plasma as we evaluate

a practical blood-based testing workflow for the Co-Dx PCR platform. While Ebola is our initial focus, we believe the longer-term significance

is the potential to expand the platform into additional applications, including HIV and hepatitis B and C. There are development and validation

efforts ahead, but success could substantially broaden the range of diseases we can address and the commercial opportunity for the platform.”

ReadyGo’s GoCollect® technology is designed

to prepare capillary blood samples for molecular testing through integrated sample-conditioning chemistry and plasma separation. Its collection

chemistry is also intended to inactivate the virus at the point of collection, an important consideration for handling samples safely

outside a laboratory. The companies are evaluating whether the resulting sample can be processed on the Co-Dx PCR platform, which is designed

to bring molecular detection to decentralized settings where outbreaks occur and to synchronize results through Co-Dx cloud infrastructure.

That compatibility has not yet been established and is the subject of the feasibility work now underway.

“We designed GoCollect for places where a laboratory

isn’t an option, where a sample either gets tested nearby or it doesn’t get tested at all,” said Ben Cobb, CEO of ReadyGo

Diagnostics. “GoCollect takes sample collection and preparation into the field, and works seamlessly with platforms such as Co-Dx

to create a complete sample-to-result molecular testing solution. Both technologies were designed around the same need, making high-quality

molecular diagnostics practical outside conventional laboratory settings. This work will demonstrate how effectively they can operate

together in the field.”

Ebola remains a fast-moving and highly lethal public

health threat. In the ongoing outbreak in the Democratic Republic of the Congo, the World Health Organization (WHO) has reported 6,757

confirmed cases and 3,267 deaths as of Sept 7, 2026, for a case fatality rate of approximately 48%, with 61 health zones affected across

six provinces. The WHO has described this as the second-largest Ebola outbreak on record and one that is spreading substantially

faster than previous outbreaks, and an imported case has been reported in France this year. In outbreaks that spread this quickly, the

speed of detection is critical, and decentralized testing that can be performed closer to patients has the potential to shorten the time

to a result.

Beyond Ebola, extending sample compatibility to blood

could broaden the range of applications the Co-Dx PCR platform can address, including testing for bloodborne pathogens such as HIV and

hepatitis B and C, a category swab-based sampling cannot reach. This category also represents substantially larger diagnostic markets

than the Company’s current menu. Each such application would require its own development, validation, and regulatory authorization.

The Company believes blood compatibility could also create additional opportunities across infectious disease testing and public health

monitoring and response.

The companies have begun feasibility work to evaluate

the compatibility and workflow integration of the two technologies, and Co-Dx has taken delivery of ReadyGo materials and devices to support

that evaluation. There can be no assurance that the evaluation will be successful or that it will result in a commercially available product.

Press Conference and Webcast:

Co-Dx will host a live press conference and webcast

on Wednesday, September 16, 2026, at 10:30 a.m. ET to discuss the collaboration and more. A live webcast, together with a replay, will

be available here, and the presentation will be posted to the Company’s Investor Relations website.

*The Co-Dx PCR platform (including the PCR Home®,

PCR Pro®, mobile app, and all associated tests) has not been cleared or authorized by the FDA, is subject to review by

the FDA and/or other regulatory bodies, and is not yet 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 (subject to regulatory review

and not currently for sale) and to identify genetic markers for use in applications other than infectious disease.

About ReadyGo Diagnostics Ltd.:

ReadyGo Diagnostics Ltd., based in Bath, United Kingdom,

develops field sample-preparation technology, including its GoCollect® product line, designed to prepare samples for molecular testing

at the point of need.

Forward-Looking Statements:

This press release contains forward-looking statements

within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such

as “believes,” “expects,” “estimates,” “intends,” “may,” “plans,”

“will,” “seeks,” “anticipates,” and similar expressions, or the negative of these terms. Forward-looking

statements in this press release include, but are not limited to, statements regarding: the anticipated benefits of the Company’s

work with ReadyGo Diagnostics; the risk that ReadyGo’s technology may not be compatible with the Co-Dx PCR platform or may not perform

as anticipated; the risk that the companies’ current evaluation activities may be modified, delayed or discontinued and may not

lead to further development activities, a commercial agreement or a commercially available product; the ability of the combined technologies

to enable decentralized Ebola detection and outbreak response; the expectation that extending sample compatibility to blood will broaden

the applications of the Co-Dx PCR platform; and the results and timing of feasibility and compatibility evaluations. Such statements are

subject to a number of risks and uncertainties, including, without limitation: risks that feasibility or compatibility studies may not

produce successful or timely results; risks that the collaboration may be modified or terminated, or may not result in a commercially

available product; risks related to the Company’s and ReadyGo’s ability to successfully integrate their respective technologies;

risks related to regulatory review by regulatory authorities that would be required to achieve a successful commercial launch; risks related

to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technologies; risks associated with dependence

on third parties, suppliers, collaborators, and distribution partners; risks related to competition, technological change, and intellectual

property protection; and other risks described from time to time in the Company’s filings with the Securities and Exchange Commission

(“SEC”). Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers

are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found

in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other

filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances

after the date of this press release, except as required by applicable law.

Investor Contact:

Valter Pinto, Managing Director

KCSA Strategic Communications

+1 212.896.1254

CODX@KCSA.com

Media Contact:

Jennifer Webb | ColtrinMethod PR

jcoltrin@coltrinmethodpr.com

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