CODX US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549.

Form

10-K

(Mark

One)

☒

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For

the fiscal year ended December 31, 2023

OR

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For

the transition period from_______to_______

Commission

File Number 001-38148

CO-DIAGNOSTICS,

INC.

(Exact

Name of Registrant as Specified in Its Charter)

2401

S. Foothill Drive, Salt Lake City, Utah84109

(Address

of principal executive offices and zip code)

(801)438-1036

(Registrant’s

telephone number including area code)

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 CODX The Nasdaq Capital Market

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934

during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject

to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data

File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding

12 months (or such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller

reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

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. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The

aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which

the common stock was last sold as of the last business day of the registrant’s most recently completed second fiscal quarter was

approximately $33,000,000.

As

of March 12, 2024, there were 31,259,668 shares of common stock, par value $0.001 per share, outstanding.

Table

of Contents

Page

PART I

Item 1. Business. 4

Item 1A. Risk Factors. 12

Item 1B. Unresolved Staff Comments. 23

Item 1C. Cybersecurity 24

Item 2. Properties. 25

Item 3. Legal Proceedings. 25

Item 4. Mine Safety Disclosures. 26

PART II

Item 6. [Reserved.] 28

Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 32

Item 8. Financial Statements and Supplementary Data. 33

Item 9A. Controls and Procedures. 55

Item 9B. Other Information. 56

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 56

PART III

Item 10. Directors, Executive Officers and Corporate Governance. 56

Item 11. Executive Compensation. 61

Item 14. Principal Accountant Fees and Services. 65

PART IV

Item 15. Exhibits and Financial Statement Schedules. 66

PART

I

Forward-Looking

Statements

This

Annual Report on Form 10-K contains “forward-looking statements” that involve risks and uncertainties. All statements other

than statements of historical fact contained in this Annual Report and the documents incorporated by reference herein, including statements

regarding future events, our future financial performance, business strategy, and plans and objectives of management for future operations,

are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,”

“believes,” “can,” “continue,” “could,” “estimates,” “expects,”

“intends,” “may,” “plans,” “potential,” “predicts,” “should,”

or “will” or the negative of these terms or other comparable terminology. Although we do not make forward looking statements

unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions

and involve known and unknown risks, uncertainties and other factors which may affect our or our industry’s actual results, levels

of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a highly regulated,

very competitive, and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all

risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors,

may cause our actual results to differ materially from those contained in any forward-looking statements.

We

have based these forward-looking statements largely on our current expectations and projections about future events and financial trends

that we believe may affect our financial condition, results of operations, business strategy, short term and long-term business operations,

and financial needs. These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results

to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences

include, but are not limited to, those discussed in this Annual Report, and in particular, the risks discussed under “Item 1,

Business,” “Item 1A, Risk Factors,” and “Item 7, Management’s Discussion and Analysis of Financial Condition

and Results of Operations,” and those discussed in other documents we file with the Securities and Exchange Commission (the

“SEC”). In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in

this Annual Report may not occur as described and actual results could differ materially and adversely from those anticipated or implied

in the forward-looking statement.

Important

factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:

● the results of clinical evaluations and the regulatory approval process;

● market acceptance of any products that may be approved for commercialization;

● our ability to protect our intellectual property rights;

● the impact of any infringement actions or other litigation brought against us;

● competition from other providers and products;

● changes in government regulation;

Should

one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ

significantly from those anticipated, believed, estimated, expected, intended or planned.

Given

these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements

contained in this Annual Report speak only as of the date of this Annual Report. We undertake no obligation to update any forward-looking

statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date

hereof.

As

used in this Annual Report, the terms “we”, “us”, “our”, “Company”, “CODX”

and “Co-Diagnostics” means Co-Diagnostics, Inc., a Utah corporation and its consolidated subsidiaries (the “Company”),

unless otherwise indicated.

ITEM

1: BUSINESS

Overview

Co-Diagnostics, Inc., a Utah corporation (the “Company” or

“CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis

of nucleic acid molecules (DNA or RNA), including robust and innovative molecular tools for detection of infectious diseases, liquid biopsy

for cancer screening, and agricultural applications. Our diagnostics systems enable dependable, low-cost, molecular testing for organisms

and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests.

CODX’s technical advance involves a novel, patented approach to PCR test design of primer and probe structure (“CoPrimersTM”)

that eliminates one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer pairs (false positives and false

negatives) which adversely interferes with identification of the target DNA/RNA. Using our proprietary test design system and proprietary

reagents, we have designed and obtained regulatory approval to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis,

hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial diagnostic tests were cleared

for use in clinical labs only and not for point-of-care or at-home use.

We

are currently developing a unique, groundbreaking portable diagnostic device and test system designed for point-of-care and at-home

use. The system is comprised of our PCR instrument that we refer to as the Co-DxTM PCR ProTM instrument, our proprietary

diagnostic test cup system and a mobile application to be installed on the user’s mobile device. We refer to the system as the

“Co-DxTM PCR platform that is being designed to bring affordable, reliable polymerase chain reaction (“PCR”)

testing to patients in point-of-care and at-home settings. The Co-Dx PCR platform is subject to U.S. Food and Drug Administration

(“FDA”) review and is not available for sale at the time of this filing. In December 2023, we submitted the Co-Dx PCR

platform for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The submission included

the PCR Pro instrument, Co-Dx PCR COVID-19 detection test cups, and mobile app, all designed for use in point-of-care and at-home

settings. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization,

or that, if regulatory approval is received, we will be able to successfully commercialize this platform.

Technology

We

believe our proprietary molecular diagnostics technology is paving the way for innovation in disease detection and life sciences research

through our enhanced detection of genetic material. For various reasons, including owning our own platform, we believe we will be able

to accomplish this faster and more economically than some competitors, allowing for significant margins while still positioning ourselves

as a low-cost provider of molecular diagnostics and screening services. For example, we were the first US-based company to receive a

CE-marking for a COVID-19 test in early 2020, as we worked to help slow the spread of the pandemic through our global network of distributors

covering clinical labs in more than 50 countries. Our Logix Smart COVID-19 test was designed, developed, submitted for regulatory approval

and ready to be used as an in vitro diagnostic or IVD in countries that accept a CE Mark as approval for use of the test in a period

of just over 30 days. This is a real-world example of how the CODX technology can be used in an evolving epidemic or pandemic to get

diagnostic tools in the hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains

of the virus should they not be detectable using currently available tests.

In

addition, continued development has demonstrated the unique properties of our CoPrimer technology that we believe makes it ideally suited

for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide

Polymorphism (“SNP”) detection and enrichment for next generation sequencing.

Our

scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that

rapidly screen millions of possible options to pinpoint the optimum design. The intellectual property we use in our business, consisting

of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represents a major

advance in PCR testing systems. CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well

as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the advantage of avoiding payment of patent

royalties required by other PCR test systems, which may allow the sale of diagnostic PCR tests at a lower price than competitors, while

enabling us to maintain profit margins.

Our

proprietary test design process involves identifying the optimal locations on the target genes for amplification and pair the locations

with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research.

This is done by following planned and documented processes, procedures and testing. In other words, we use the data resulting from our

tests to verify whether we succeeded in designing what we intended. Verification involves a series of testing that concludes that the

product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial

production tests to confirm that the product as designed meets the user needs.

Using

our proprietary test design system and proprietary reagents, we have designed and obtained regulatory approval in the European Community

and in India to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus,

malaria, chikungunya, dengue, and the Zika virus. In the United States, we obtained Emergency Use Authorization (“EUA”) for

our Logix Smart® COVID-19 detection test from the Food and Drug Administration, or

FDA, and we sell that test to qualified labs. In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products

have been approved for sale in countries such as the United Kingdom, Australia and Mexico by the regulatory bodies in those countries

and have been registered for sale in many more countries. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained

lab systems (which we refer to as the “MDx Device”).

In

addition to testing for infectious disease, the technology lends itself to identifying any section of a DNA or RNA strand that describes

any type of genetic trait, which creates several significant applications. We, in conjunction with our customers, have designed and licensed tests that identify genetic traits in plant and animal genomes. We also have three multiplexed tests developed

to test mosquitos for the identification of diseases carried by the mosquitos to enable municipalities to concentrate their efforts in

managing mosquito populations on the specific areas known to be breeding the mosquitos that carry deadly viruses.

Co-Dx

PCR Platform

We believe the benefits of affordable,

high-quality diagnostics should be available to everyone. High-quality point-of-care PCR testing plays a crucial role in healthcare.

It enables rapid diagnosis of infectious diseases, such as COVID-19 or tuberculosis, facilitating timely treatment and containment

measures. By delivering results on-site, it eliminates the need for sample transportation, reducing the risk that the sample is

transported incorrectly or lost enroute, reducing turnaround time to results, and allowing for immediate decision-making. The

quality of PCR testing at the point of care ensures reliable detection of pathogens, minimizing incorrect results. In short,

high-quality PCR testing at home and at the point of care enhances patient care, public health response, and helps control the

spread of infectious diseases. That is why we are developing the Co-Dx PCR platform utilizing our Co-PrimersTM real-time PCR

technology for at-home and point-of-care testing. Because we believe that testing for COVID-19 and other infectious diseases will

continue to be a consideration for public health worldwide, we initiated the Co-Dx PCR platform to facilitate frequent, affordable,

reliable polymerase chain reaction (“PCR”) testing to patients in point-of-care and at-home settings, including schools,

businesses, and the hospitality industry. We believe this may be accomplished through the development of a testing system comprised

of a compact, relatively low-cost testing device, the Co-Dx PCR Pro instrument, together with proprietary diagnostic test cups that

work with the Co-Dx Pro instrument and a mobile application, that is easy to use by professionals and non-professionals, that can

provide PCR test results in around 30 minutes. We believe that as user test results are gathered in the cloud following completion

of tests, the data may be useful for governmental health agencies and the World Health Organization to determine where outbreaks of

infectious diseases may be occurring and enable them to act more quickly and efficiently and slow-down or perhaps even prevent

further spread.

The 6 1⁄2” x 4 1/2” x 6”, 2

lbs. Co-Dx PCR Pro instrument operates via a smartphone app with simple-to-follow instructions that includes videos to walk users through

every step, some sample swab collection to the straightforward instrument operation. Results are processed in the cloud and delivered

back to the user’s smartphone or tablet in about 30 minutes using software designed from the ground-up for this specific use. The

PCR tests themselves (contained in the simple but unique, innovative test collection cups) are powered by patented Co-Dx Co-Primers PCR

technology.

The initial diagnostic test designed for use on this

platform, an at-home and point-of-care COVID-19 PCR test, was ultimately facilitated by our development of a saliva or nasal swab-based

PCR test that does not require RNA/DNA extraction. The final result is believed to be approximately equivalent to those processed by a

high-complexity clinical laboratory. Our COVID-19 PCR platform test has the advantages of increased speed and ease of handling thanks

to lyophilization (or freeze-drying) of our testing reagents to allow for stability at room temperatures. In December 2023, we submitted

our proprietary Co-Dx PCR COVID-19 test cups with the Co-Dx PCR Pro instrument and mobile application, all designed for use in point-of-care

and at-home settings, for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). We are also preparing

a 510K for submission to the FDA should the FDA decline to grant our emergency use authorization request.

We expect to develop further diagnostic tests for

use with the PCR Pro instrument, including a multiplex test for influenza, RSV and COVID-19. To that effect, we were awarded $1.2 million

in funding from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for

completion of our upper respiratory panel diagnostic test for use on the Company’s Co-Dx PCR platform. We will utilize the funds from

the RADx Tech award to complete development of our flu A/B, COVID-19, and RSV multiplex test, preparatory for that test to begin clinical

trials on the Co-Dx PCR Pro instrument. The NIH launched the RADx initiative on April 29, 2020, with the goal of speeding innovation in

the development, commercialization, and implementation of technologies for COVID-19 testing, leveraging the existing NIH Point-of-Care

Technology Research Network. The RADx Tech program is managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB),

to support the accelerated development of tests and provide regulatory guidance during the COVID-19 pandemic and beyond.

We

are also developing diagnostics tests for TB and HPV for use with our Co-Dx PCR platform. We have been awarded two grants in the amounts

of $10.23 million and $987,000 by the Bill & Melinda Gates Foundation to support the development and manufacture of TB and HPV tests

for our Co-Dx PCR platform. In 2014, all United Nations Member States and the World Health Organization (WHO) committed to ending the

global TB epidemic by 2030, before the COVID-19 pandemic slowed, stalled or reversed progress of global TB targets. The WHO estimates

that roughly 4.2 million cases of TB went unidentified in 2021 worldwide, representing nearly 40% of actual cases, highlighting the need

for a dramatic increase of affordable, high-quality, point-of-care TB diagnostics to enable rapid treatment decisions to be made for

a disease that has a mortality rate of about 50% if left untreated. The National Cancer Institute estimates that high-risk HPVs cause

roughly 5% of all cancers worldwide, with the rate among women being nearly 10 times higher than that for men and leading to an estimated

264,000 cervical cancer deaths each year according to the WHO. More than 85% of these deaths are in low- and middle-income countries,

and all of which the WHO believes can be dramatically reduced by access to diagnostics, vaccinations, and cancer screenings.

Infectious

Disease Product Offering

Using

our proprietary test design system and proprietary reagents, we and CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture

for manufacturing in India, design and sell PCR diagnostic tests for detection of diseases and pathogens such as COVID-19, influenza,

tuberculosis, hepatitis B and C, malaria, dengue, human papillomavirus, chikungunya, and Zika virus, all of which tests have been designed

and verified in our laboratories. Our tuberculosis test and Zika test received a CE Mark in 2018, and a triplex test for Zika, dengue

and chikungunya received a CE Mark in 2019, qualifying the tests to be sold throughout the European community and in most countries in

Central and South America. In December 2019, CoSara received a license to manufacture and sell tuberculosis, hepatitis B, hepatitis C,

human papillomavirus 16/18 and malaria tests in India from the Central Drugs Standard Control Organization (“CDSCO”). In

February 2020, we received a CE Mark for our Logix Smart COVID-19 test followed by an EUA by the FDA in April 2020. Also, in April 2020,

our COVID-19 test was approved for manufacture and sale in India by the CDSCO and in Mexico by the INDRE, Mexico’s equivalent to

the United States Center for Disease Control. In August 2020, we received approval from the Australian Department of Health Therapeutic

Goods Division to sell our COVID-19 test in Australia.

As

explained above, our Logix Smart COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an

in vitro diagnostic or IVD in countries that accept a CE Mark as approval for use of the test in a period of just over 30 days.

This is a real-world example of how the CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the

hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of the virus should

they not be detectable using currently available tests.

Caribbean

and Central and South America

We

began selling PCR diagnostic tests to entities located in South and Central America and the Caribbean in 2018. In some of those countries,

there are limited regulatory hurdles, allowing us to begin offering our tests immediately. We have applied for and received registrations

for our tests in many of those countries that require registration, and our distributors in those countries have provided us with in-country

assistance in completing such registrations.

We

first offered our Zika test in this region because of the demand for such a test, followed by tests for tuberculosis, and our triplex

test for Zika, chikungunya, and dengue. Sales of those tests have not been material, but with the granting of a CE mark for our Logix

Smart COVID-19, we experienced an increase in sales in this region.

India

In

January 2017, the Company entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical

manufacturing company in India and formed CoSara as an Indian joint venture. The agreement provided for the construction of a manufacturing

plant and the manufacture of the tests named above and the joint sales and marketing of those tests in India. We have received a license

for the plant in Ranoli, India to manufacture approved tests and it is being used for testing and manufacturing of our products for the

Indian market.

As

mentioned above, the CDSCO has given us the approval for manufacture and sale of the 15 tests referred to above, and the Company’s

joint venture manufactures and sells those tests. The Company manages a reagent rental program in India with thermocyclers purchased

from third-party vendors and which we refer to as our MDx Device. The placement of thermocyclers in India has facilitated the sale of

the SaraGene PCR tests in India. The WHO 2022 Global Tuberculosis Report indicates that India is the country with the highest number

of cases of tuberculosis in the world. WHO tuberculosis statistics for India for 2022 give an estimated incidence figure of 2.82 million

cases of tuberculosis for India out of a global incidence of approximately 10.0 million.

On

March 19, 2020, we announced that CoSara received authorization to manufacture and sell COVID-19 tests in India. Those tests in India

are branded as SaraGene COVID-19 tests and are sold exclusively by CoSara. The Indian government places restrictions on the price that

could be charged for COVID-19 tests which limited the revenue in India more than we experienced in other parts of the world. At the time

of this report, CoSara has received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis

C (including viral load tests for both hepatitis B and C), human papillomavirus (HPV), a test for high-risk HPV, two COVID-19 assays,

chikungunya, dengue, a dengue/chikungunya duplex test, an influenza A/influenza B/COVID-19 (“ABC”) multiplex test, and in

2024 CDSCO cleared the manufacture and sell SARAPLEXTM Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro

diagnostic for the detection and differentiation of Influenza A and Influenza B.

Europe

Molecular

diagnostics, such as our tests, are governed in Europe by the framework for IVDs, which encompasses diagnostic products such as reagents,

instruments and systems intended for use in diagnosis of disease. The regulatory system for some IVDs has historically allowed for a

self-certification procedure, placing heavy responsibility on manufacturers. Non self-certified products were subject to the same standards

as self-certified products but were also subject to audit and review by a notified body prior to receiving approval to be CE-marked.

A CE-marking is a manufacturer’s declaration that a product meets the requirements of the applicable European Commission directive.

Examples of current obligations include having in place a qualitative manufacturing process, user instructions that are clear and fit

for purpose, and ensuring that the ‘physical’ features of devices and diagnostics do not pose any danger. If a product fulfils

these and other related control requirements, it may be CE-marked, as an indication that the product is compliant with EU legislation

and sold in the European Union. We have received CE Marks for six of our tests including for COVID-19, COVID-19 (2 gene test), ABC (a

triplex test for Flu A, Flu B and COVID-19), a DS (Direct Saliva, extraction-free) COVID-19 test, tuberculosis, Zika, and our Zika, dengue,

chikungunya triplex tests. The European Commission has revised its directive governing the CE- marking of IVDs, which included

reclassifying which IVDs may be self-certified, and which may not. As a result of this change in directive and reclassification, substantially

all of the Company’s products are now subject to audit and review by a notified body, as well as a more rigorous clinical evaluation

process, prior to receiving approval to be CE-marked.

We

are ISO 13485:2016 certified, relating to the design and manufacture of our medical device products. The ISO certification indicates

that we meet the standards required to pursue CE-marking for certain of our products and affix a CE-marking for sales of our products

in countries accepting CE-marking (not in the United States).

United

States

The

FDA has granted permission for us to export all of our IVD products. The FDA’s permission to export was granted under Section 801(e)

of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDC Act”). Section 801(e) of the FDA Act covers certain medical

devices that have not yet received an approved Premarket Approval in the United States by the FDA, such as our products. We have not

commenced any Premarket Approval steps with the FDA. Section 801(e) of the FDA Act applies to medical devices that are acceptable to

the importing country and that are manufactured under the FDA’s Good Manufacturing Practices. We have received EUA for our COVID-19

test, which allows sales to qualified labs in the United States and facilitates the registration for sale in other countries as well.

Under the FDA’s existing policy, the FDA continues to review a prioritized subset of COVID-19 tests for EUAs, and emphasizes that

traditional device premarket review pathways remain open to all developers. We intend to pursue all appropriate FDA review pathways for

products under development, including traditional premarket review pathways.

Under

our EUA, we are actively selling our Logix Smart COVID-19 test to CLIA certified laboratories in the United States. The CLIA labs are

able to use our test, or to further validate our COVID-19 tests (or other tests) as Laboratory Developed Tests (LDTs), which refers to

a diagnostic test that has been validated for use in the CLIA lab. LDTs may be used by the lab only in that laboratory. CLIA laboratories

develop the performance characteristics, perform the analytical validation for their LDTs and obtain licenses to offer them as diagnostic

services. We are currently marketing our Logix Smart COVID-19 test to CLIA laboratories throughout the US.

Market

Opportunity

The

market opportunity for our tests changed radically with the emergence of the COVID-19 pandemic. Because we were able to respond rapidly

and produce a quality product, we have been able to build a worldwide distribution network, most

of which have been the sales network that has allowed us to export products throughout the world. Our network of distributors

that we have built over the past three years will serve us well in sales and distribution of other diagnostic tests and our forthcoming

PCR diagnostic platform.

The

molecular diagnostics market is a fast-growing portion of the in vitro (test tube-based, controlled environment) diagnostics market.

There are several advantages of PCR tests, such as the ones we market and sell, over other forms of diagnostic testing. These advantages

include higher specificity and sensitivity, the ability to perform multiplex tests and the ability to test for drug resistance or for

individual genes.

Mosquito

Vector Control Services

In

response to market demand, in June 2019 we introduced our first diagnostics tests to be used exclusively to test for mosquito borne pathogens

in mosquito populations. Municipalities in the US and many other countries in the world are concerned about the diseases carried by mosquitos,

which infect the human population. To prevent outbreaks of potentially harmful viruses such as Zika or West Nile from infecting the public,

many municipalities conduct mitigation operations to eliminate the mosquito populations carrying the diseases. Because it is too expensive

and potentially harmful to the environment to spray all mosquito breeding areas, municipalities identify which particular area has mosquitos

that are carrying the harmful viruses. To know where the host mosquitos with the harmful viruses are located, traps are set, mosquitos

collected and then tested to find the areas that most needed spraying. There are over 3,000 mosquito abatement districts throughout the

United States and almost all of them conduct testing to help make the spraying more effective.

Our

first vector related test was a triplex test that tests for West Nile, western equine and St. Louis encephalitis. We began shipping the

tests in June 2019. We added a second test that tests mosquitos for Zika, chikungunya and dengue in a triplex test. Finally, in November

2019, we completed a test for West Nile, eastern equine and St. Louis encephalitis, specifically for use in the eastern United States.

As a result, mosquito abatement districts can test for three target viruses in one test as compared to performing three different tests

using other market available tests. Our products allow municipalities to obtain test results in a matter of hours, instead of the weeks

they might otherwise have to wait for a central lab to process the mosquito tests.

We

have sold our Vector SmartTM test products and/or related lab equipment to testing districts in different sections of the country

and are marketing our products through trade shows, electronic and regular mail solicitations.

Liquid

Biopsy for Cancer Screening

The

enhanced specificity of our technology opens up some unique applications for liquid biopsy, demonstrating its ability to detect small

quantities of mutations associated with cancer within an environment of large amounts of normal DNA, as we position the Company to take

part in this historic and challenging development in human health care.

Agricultural

Applications

SNP

detection is also used in the agricultural industry to identify variations in crop genomes to achieve improved seed viability and other

desired characteristics, including drought resistance, disease resistance, pest resistance and higher yield.

In

mid-2017, the Company was first approached by a large agribusiness to evaluate our ability to multiplex certain target genomes. The results

of the development project have successfully demonstrated our ability to not only multiplex the target genomes, but targeted SNP’s

as well. The project was undertaken in conjunction with the manufacturer of our CoPrimers tests. The results of the project encouraged

the parent of our manufacturer to seek a world-wide licensing arrangement for our CoPrimers in the agricultural industry, which was completed

in October 2018. Pursuant to the exclusive license for the agronomics industry, the licensee pays us a royalty for all CoPrimers sold

to the licensee’s customers. In January 2019, the licensee formally introduced the product at a large agricultural conference and

has branded the product under the name “BHQ CoPrimers”.

Additional

Licensing and Assay Development

We

believe the unique properties of our CoPrimers technology make them ideally suited to a variety of applications where sensitivity is

key to optimal results, including multiplexing several targets, enhanced SNP detection and enrichment for next generation sequencing.

Our licensee for our agricultural testing requested an expansion of our license agreement to include test design services for their customers

and potential customers, both in the infectious disease arena as well as for agricultural customers. The license was amended in July

2019 and we expect to derive a license fee from our licensee for its design services. If any of its customers desire to commercialize

the tests designed, they will need to seek a commercial license directly from us. Thanks to these unique characteristics of CoPrimers,

research companies and institutions have requested that we design diagnostics to locate and identify uncommon gene sequences and SNPs

and create tests for the target sequences in a multiplexed reaction. This application of our technology is in its beginning stages, but

we believe that the results from our initial research indicate a significant step forward in defining the capabilities of our technology,

which we believe can be translated to revenue producing licensing arrangements. However, there can be no guarantee that we will be able

to develop the requested capabilities, or that we will be able to successfully commercialize this application of our technology.

Competitive

Advantages of Co-Diagnostics

We

believe that we have the following competitive advantages:

Intellectual

Property

Much

of our future success and value depends on our proprietary technology, and therefore, our patent and intellectual property strategy is

of critical importance. Currently, our flagship CoPrimers technology is covered by two U.S. patents titled “Cooperative primers,

probes, and applications thereof” as well as by granted and pending foreign counterparts. We have another three U.S. patents directed

to our earlier work in primer and assay designs. For more recent works, we have filed international and U.S. patent applications directed

to “Methods and Compositions for Next Generation Sequencing (NGS) Library Preparation,” “Allele-Specific Design of

Cooperative Primers for Improved Nucleic Acid Variant Genotyping,” “Methods and Compositions Related to Cooperative Primers

and Reverse Transcription,” and “Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis”

which is the basis of our at-home and point-of-care PCR system. We intend to continue building our patent portfolio as development continues

and resources are available.

We

also protect some of our technology and know-how as trade secrets and, where appropriate, we use and register trademarks to protect and

strengthen our products and proprietary brands. All trademarks, trade/product names, graphics and logos of Co-Diagnostics contained herein

are trademarks of Co-Diagnostics or its subsidiary, as applicable, in the U.S. and/or other countries. Solely for convenience, we may

refer to trademarks in this Annual Report on Form 10-K without the TM or ® symbols, but such references are not intended to

indicate, in any way, that we will not assert, to the fullest extent permitted by law, our rights to our trademarks.

Major

Customers

The

Company had certain customers which were each responsible for generating 10% or more of the total revenue for the years ended December

31, 2023 and 2022, respectively. Two customers accounted for approximately 28% of product revenue for the year ended December 31, 2023

and one customer accounted for approximately 37% of product revenue for the year ended December 31, 2022. One granting agency accounted

for 100% of grant revenue for the year ended December 31, 2023. These customers and granting agencies may not account for the same percentage

of product revenue or grant revenue in future periods. If

we were to sell nothing to those customers in the future, it would have a material adverse effect on our financial condition unless we

were able to replace those customers with others.

Competition

The

molecular diagnostics industry is extremely competitive. There are many firms that provide some or all of the products we provide and

provide many diagnostic tests that we have yet to develop. Many of these competitors are larger than us and have significantly greater

financial resources. Because we are more recently established, many of our competitors have a competitive advantage in the diagnostic

testing industry because they also have other lines of business in the pharmaceutical industry from which they derive revenues and for

which they are well known and respected in the medical profession. We will need to overcome the disadvantage of being perceived as a

start up with no significant recognition from the medical and testing professionals, although we believe this is changing as we continue

to market our Logix Smart COVID-19 tests and other tests in the United States to well-known and successful laboratories. Many of these

competitors already have an established customer base with industry standard technology, which we must overcome to be successful. In

the diagnostic testing and POCT industries, we compete with such companies as BioMerieux, Siemens, Qiagen, Cue Health, Lumira Dx and

Cepheid and with such pharmaceutical companies as Abbott Laboratories, Becton Dickinson and Johnson and Johnson. We also compete with

companies from Asia in certain markets who are willing to sell their tests for much less than we sell our tests, which creates competitive

price pressure on us in certain regions, particularly Asia and Latin America.

We

expect competition to continue to increase as other established and emerging companies enter the market, as customer requirements evolve,

and as new products, services and technologies are introduced. Some of our existing or new competitors may have strong

relationships with current and potential customers, including governmental authorities, and, as a result, may be able to respond more

quickly to new or changing regulatory requirements, new or emerging technologies, and changes in customer requirements.

Government

Regulation

In

the United States, we are regulated by the FDA and our products must be approved, cleared, or authorized by the FDA before we are allowed

to sell our tests in the United States as in vitro diagnostics. The FDA granted us an EUA to manufacture and sell our Logix Smart

COVID-19 test to CLIA labs in the United States. We are ISO 13485:2016 certified, relating to the design and manufacture of our medical

device products. Being ISO certified greatly facilitates our applications for CE-Marking, which allows us to sell any CE Marked test

in most countries in Europe, South America and Asia, depending on the country and following that country’s registration process.

We currently have CE Markings issued for our Logix Smart COVID-19 test, tuberculosis test, our Zika virus test, a triplex test that tests

for Zika, dengue, and chikungunya simultaneously, a triplex “ABC” test that identifies and distinguishes between Flu A, Flu

B and Covid-19, our SARS-CoV-2 2-gene multiplex test, and our DS (Direct Saliva, extraction-free) COVID-19 test. In addition, our Logix

Smart COVID-19 has received the required license to manufacture and sell in India from India’s CDSCO, and The National Epidemiology

Institute in Mexico evaluated our Logix Smart COVID-19 and ABC tests and approved them for sale in Mexico. We have also received approval

to sell in Australia.

Employees

As

of December 31, 2023, we had 155 full-time and part-time employees at our executive offices and lab facilities in Salt Lake City, Utah.

We have engaged independent contractors to promote the use of our products and develop outlets for products and employ the services of

independent sales representatives on an “as needed” basis.

We

consider our people and the way we work to support each other and serve our customers to be critical to our success. The key human capital

measures and objectives that we focus on in managing our business are: maintaining a strong and collaborative company culture, increasing

our diversity, inclusion and belonging, offering fair and competitive compensation and benefits, investing in people and organizational

development, protecting and enriching employee health and wellness, and sustaining a culture of respectful and effective communications.

Organizational

History and Corporate Information

We

were incorporated as Co-Diagnostics, Inc., in Utah on April 18, 2013. Our principal executive office is located at 2401 S. Foothill Drive,

Salt Lake City, Utah 84109. Our telephone number is (801) 438-1036. Our web address is www.codiagnostics.com. The contents of

our website are not incorporated by reference in this Annual Report.

ITEM

1A. RISK FACTORS

Risks

Related to Our Business and Industry

We

have limited commercial history upon which to base our prospects and are not certain that we will achieve profitability in the future.

We

have a limited operating history. We began operations in April 2013. Our accumulated retained earnings were $4.6 million and $39.9 million

as of December 31, 2023 and 2022, respectively. During the calendar years ending December 31, 2023 and 2022 we experienced a decline

in demand for our Logix Smart COVID-19 and other COVID-19 tests and operated at a net loss during the periods. We do not have any way

of predicting when or if we will achieve profitability again. Potential investors should be aware of the difficulties normally encountered

by a new enterprise, many of which are beyond our control, including substantial risks and expenses in the course of developing new diagnostic

tests, establishing or entering new markets, organizing operations and marketing procedures. The likelihood of our success must be considered

in light of these risks, expenses, complications and delays, and the competitive environment in which we operate. There is, therefore,

nothing at this time upon which to base an assumption that our business plan will prove successful, and we may not be able to generate

significant revenue, raise additional capital or operate profitably. We will continue to encounter risks and difficulties frequently

experienced by early commercial stage companies, including scaling up our infrastructure and headcount, and may encounter unforeseen

expenses, difficulties or delays in connection with our growth. In addition, as a result of the start-up nature of our business, we expect

to continue to sustain substantial operating expenses and may not be able to continue generating sufficient revenues to cover expenditures.

Any investment in our company is therefore highly speculative and could result in the loss of any investment.

Our

future success is dependent on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including

the PCR Pro instrument and related diagnostic tests, demand for infectious disease diagnostics and upon our ability to develop and market

other commercially accepted diagnostic tests for our PCR platform.

Our

future success will depend, in part, on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including

the PCR Pro instrument and related diagnostic tests, our ability to develop and sell sufficient quantities of other diagnostics tests,

and our ability to successfully and profitably market our Co-Dx PCR platform. Attracting new customers and distribution networks requires

substantial time and expense. Any failure to obtain regulatory approval for our product candidates and to increase sales of our diagnostic

tests in sufficient quantities to achieve profitability in a timely manner would adversely affect our operating results. Many factors

could affect the market acceptance and commercial success of any of our diagnostic tests and devices, including:

● the breadth of our test menu relative to competitors;

● the extent and success of our marketing and sales efforts; and

The

diagnostic market is highly competitive, and we may not be able to compete effectively against the larger, well-established companies

that dominate this market or emerging and small innovative companies that may seek to obtain or increase their share of the market.

The

markets for diagnostic products are intensely competitive, and many of our competitors are much larger and have substantially more financial

and human resources than we do. Many have long histories and strong reputations within the industry, and a relatively small number of

companies dominate these markets.

These

companies enjoy significant competitive advantages over us, including:

● products that are supported by long-term clinical data;

● greater financial and other resources for product research and development;

● established manufacturing operations and contract manufacturing relationships;

● significantly greater name recognition and widely recognized trademarks; and

● established relationships with healthcare providers and payers.

Our

products and any product candidates that we may introduce into the market may not enable us to overcome the competitive advantages of

these large and dominant companies. In addition, even if we successfully introduce additional product candidates into the market, emerging

and small innovative companies may seek to increase their market share and they may eventually possess competitive advantages, which

could adversely impact our business. Our competitors may also employ pricing strategies that could adversely affect the pricing of our

products.

We

depend on a limited number of third-party suppliers for key raw materials used in the manufacturing of our products, and the loss of

these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.

We

rely on a limited number of third-party suppliers for the raw materials required for the production of our diagnostic products and product

candidates. Our dependence on a limited number of third-party suppliers involves several risks, including limited control over pricing,

availability, quality, and delivery schedules for raw materials. We have no supply agreements in place with any of our suppliers and

cannot be certain that our current suppliers will continue to provide us with the quantities of raw materials that we require or that

satisfy our anticipated specifications and quality requirements. Any supply interruption in limited or single sourced raw materials could

materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified. We may

be unable to find a sufficient alternative supply channel within a reasonable time or on commercially reasonable terms. Any performance

failure on the part of our suppliers could delay the production of our products and product candidates and delay the development and

commercialization of our product candidates, including limiting supplies necessary for commercial sale, clinical trials and regulatory

approvals, which could have a material adverse effect on our business.

In

order to be successful, we must expand our available product lines by commercializing new product candidates, but we may not be able

to do so in a timely fashion and at expected costs, or at all.

Although

we are currently manufacturing diagnostic kits for commercialization, in order to be successful, we will need to expand our product lines

to include other diagnostic products. To succeed in our commercialization efforts, we must effectively continue product development and

testing, find new strategic partners, obtain regulatory clearances and approvals, and enhance our sales and marketing capabilities. Because

of these uncertainties, there is no assurance that we will succeed in bringing any of our current or future product candidates to market.

If we fail in bringing our product candidates to market, or experience delays in doing so, we will not generate revenues as planned and

will need to curtail operations or seek additional financing earlier than otherwise anticipated.

We

are dependent on our senior management team, scientific team, and external advisors, and the loss of any of them could harm our business,

including by adversely affecting our ability to effectuate our business strategy.

The

members of our current senior management team may not be able to successfully implement our strategy. In addition, we have not entered

into employment agreements with any of the members of our senior management team. There are no assurances that the services of any of

these individuals will be available to us for any specified period of time. The successful integration of our senior management team,

the loss of members of our senior management team, scientific team and key external advisors, or our inability to attract or retain other