What changed in this filing

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Item 1. Business

2023-03-16 compared with 2022-03-24 · 299 added, 313 removed, 113 unchanged (84% of the section changed)

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.

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”).

We have also developed a unique, groundbreaking portable PCR device (the “CODX YourTest

PCR™ Device”) that has been designed to bring affordable, reliable gold-standard polymerase chain reaction (“PCR”)

to patients in point-of-care and even at-home settings.

diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating historically complex

procedures in both the development and administration of tests.

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.

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

We are also developing a unique, groundbreaking portable PCR device and proprietary test cups (the “Co-Dx PCR Home™

platform”) that have been designed to bring affordable, reliable polymerase chain reaction (“PCR”) to patients in point-of-care

and even at-home settings.

This platform is subject to U.S.

Food and Drug Administration (“FDA”) review and is not available

for sale at the time of this filing.

There is no guarantee that our Co-Dx PCR Home 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.

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 (“CoPrimers™”) 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.

to PCR test design of primer and probe structure (“CoPrimers™”) 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.

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 our platform, we believe we will be

able to accomplish this faster and more economically, allowing for significant margins while still positioning the Company to be a low-cost

provider of molecular diagnostics and screening services.

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.

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

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

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

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.

Brent Satterfield, our founder, developed the Company’s

intellectual property consisting of the predictive mathematical algorithms and patented molecular structure used in the testing process,

which together represent 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.

may either sell or lease the MDx Device to labs and diagnostic centers, through sale or lease agreements, and sell the reagents that

comprise our proprietary tests to those laboratories and testing facilities.

Brent Satterfield, our founder, developed 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 represent 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.

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

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In other words, we use the data resulting from our

tests to verify whether we succeeded in designing what we intended at the outset.

Verification is 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.

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.

may either sell or lease the MDx Device to labs and diagnostic centers, through sale or lease agreements, and sell the reagents that

comprise our proprietary tests to those laboratories and testing facilities.

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

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malaria, chikungunya, dengue, and the Zika virus.

In the United States, CODX has obtained Emergency Use Authorization (“EUA”)

for its Logix Smart ™ COVID-19 detection test from the Food and Drug Administration,

or FDA, and sells that test to qualified labs.

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

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and have been registered for sale in many more countries.

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

any type of genetic trait, which creates a number of significant applications.

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, are active in designing

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

January 23, 2020, we announced the completion of the principal design work for a PCR test for the new coronavirus, later named COVID-19,

intended to address the potential need for detection of the virus.

This test features the Company’s patented CoPrimer technology,

and was designed using our proprietary software system, following the guidelines published by the World Health Organization (WHO) and

Centers for Disease Control (CDC).

February 24, 2020, we announced that this test had obtained regulatory clearance to be sold as an IVD for the diagnosis of COVID-19 in

markets that accept CE-marking as valid regulatory approval, and became available for purchase from the Company’s Utah-based ISO-13485:2016

certified facility—the first US-based company to obtain such a marking for a COVID-19 test.

January 23, 2020, we announced the completion of the principal design work for a PCR test for COVID-19, intended to address the potential

need for detection of the virus.

This test features our patented CoPrimers technology, and was designed using our proprietary software

system, following the guidelines published by the World Health Organization (WHO) and Centers for Disease Control (CDC).

February 24, 2020, we announced that this test had obtained regulatory clearance to be sold as an in vitro diagnostic (“IVD”)

for the diagnosis of COVID-19 in markets that accept CE-marking as valid regulatory approval and became available for purchase from our

Utah-based ISO-13485:2016 certified facility.

commenced sales of the COVID-19 tests in February and March of 2020 to international customers and to date have since sold over 34,000,000

of this and other COVID tests in numerous countries around the world through an expanding distributor network.

April 6, 2020, we announced that we had received an Emergency Use Authorization from the FDA allowing us to commence sales of our Logix

Smart™ COVID-19 test to laboratories certified by the Center for Medicare and Medicaid Services under the Clinical Laboratories

Improvements Act (“CLIA”) to accept human samples for diagnostics testing throughout the United States and have sold our

Logix Smart™ COVID-19 test to such CLIA labs since that time.

we believe that testing for COVID-19 is going to be a consideration for public health worldwide even after the current pandemic has subsided,

we have initiated the Eikon platform to facilitate frequent testing in homes, schools, businesses, and the hospitality industry.

this may be accomplished through the development of a low-cost testing device, easy to use by non-professionals, that can provide PCR

test results in around 30 minutes.

April 6, 2020, we announced that we had received an EUA from the FDA allowing us to commence sales of our Logix Smart COVID-19 test to

laboratories certified by the Center for Medicare and Medicaid Services under the Clinical Laboratories Improvements Act (“CLIA”)

to accept human samples for diagnostics testing throughout the United States and have sold our Logix Smart COVID-19 test to such CLIA

labs since that time.

we believe that testing for COVID-19 will continue to be a consideration for public health worldwide, we have initiated the Co-Dx PCR

Home platform to facilitate frequent testing in homes, schools, businesses, and the hospitality industry.

We believe this may be accomplished

through the development of a compact, relatively low-cost testing device, easy to use by non-professionals, that can provide PCR test

results in around 30 minutes.

The initial project built 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 the RNA/DNA extraction.

While the final

result is believed to be approximately equivalent to those processed by a high-complexity clinical laboratory, it 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.

February 15, 2021, we engaged the services of a group of professionals at Idaho Molecular, Inc and Advanced Conceptions, Inc (the “Entities,”)

with the expertise to develop the hardware for such a device using our CoPrimers™ as the reagent chemistry.

22, 2021, we announced that we would be acquiring the Entities along with all existing and future assets and intellectual property related

to the platform and device.

It is expected that the device and test will be available to homes, schools, offices, and the travel industry

among other locations at a cost that will allow screening frequently to prevent spread of the COVID-19 virus in the future.

would also be available to test for other pathogens detectable through saliva or other samples as we develop those tests and offer them

to the marketplace.

While we believe

the final result is believed to be approximately equivalent to those processed by a high-complexity clinical laboratory, it our COVID-19

PCR 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.

February 15, 2021, we engaged the services of a group of professionals at Idaho Molecular, Inc (“IdMo”) and Advanced Conceptions,

Inc (“ACI”), with the expertise to develop the hardware for a device using our CoPrimers as the reagent chemistry.

2021, we announced the closing of the acquisitions of IdMo and ACI along with all existing and future assets and intellectual property

related to the platform and device.

It is expected that the device and test will be available to homes, schools, offices, and the travel

industry among other locations, at a cost that will allow screening frequently to prevent spread of the COVID-19 virus in the future,

as well as other diseases as additional single- and multiplex tests are developed and validated for use on the device.

The device would

also be available to test for other pathogens detectable through saliva or other samples as we develop those tests and offer them to

the marketplace.

All such tests will be subject to regulatory approval.

February 22, 2023, we announced that clinical evaluations for the device and its initial test for COVID-19 had begun.

Because the evaluations

are dependent on identifying and enrolling a particular number of both symptomatic and asymptomatic COVID-19-positive and -negative patients

at testing sites, the Company did not provide projected timelines for completion at that time.

Disease Product Offering

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, 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

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 Emergency Use Authorization by the FDA a few weeks later, and

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.

Other regulatory approvals and registrations followed those listed

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

used as an 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 to get diagnostic tools in the hands of medical professionals

without delay.

It can be similarly used to design a test for mutated strains of the virus should they not be detectable using currently

available tests.

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.

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.

and Central and South America

initial sales were to entities located in South and Central America.

In some of those countries, there are limited regulatory hurdles

so we started 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.

first offered our Zika test in this region because of the demand for such a test, followed by tests for tuberculosis, 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 began significant sales in this region.

Products are manufactured for sale upon receipt of purchase orders from distributors,

labs and hospitals.

began selling PCR diagnostic tests to entities located in South and Central America and the Caribbean in

In some of those countries, there are limited regulatory hurdles, allowing us to begin offering our tests immediately.

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.

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.

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 an Indian joint venture organized as CoSara Diagnostics, Pvt Ltd (“CoSara”).

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 is being

used for testing and manufacturing of our products for the Indian market.

mentioned above, the CDSCO has given us the approval for manufacture and sale of the nine tests referred above and the Company has begun

manufacture and sale of those tests.

The Company has commenced a reagent rental program in India with thermocyclers purchased from third-party

vendors and which we refer to as our MDx Device.

Each of the reagent rental placements requires the purchase of a minimum number of tests

The placement of thermocyclers in India has facilitated the sale of the SaraGene COVID-19 tests in India.

The World Health

Organization (“WHO”) 2019 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 2018 give an estimated incidence figure of 2.69 million cases

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

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.

mentioned above, the CDSCO has given us the approval for manufacture and sale of the nine tests referred to above, and the Company’s joint venture has begun manufacture and sale of those tests.

The Company has

commenced a reagent rental program in India with thermocyclers purchased from third-party vendors and which we refer to as our MDx Device.

Each of the reagent rental placements requires the purchase of a minimum number of tests per month.

The placement of thermocyclers in

India has facilitated the sale of the SaraGene COVID-19 tests in India.

The WHO 2019 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 2018 give an

estimated incidence figure of 2.69 million cases of tuberculosis for India out of a global incidence of approximately 10.0 million.

March 19, 2020, we announced that CoSara received authorization to begin manufacture and sale of COVID-19 tests in India.

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The Indian government places restrictions on the

price that could be charged for COVID-19 tests which has limited the revenue in India more than we have experienced in other parts of

At the time of this report, CoSara has received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria,

hepatitis B, hepatitis C, human papillomavirus (HPV), two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and

an influenza A/influenza B/COVID-19 (“ABC”) multiplex test.

diagnostics, such as our tests, are governed in Europe by the framework for in vitro diagnostics (IVDs), which encompasses diagnostic

products such as reagents, instruments and systems intended for use in diagnosis of disease.

The regulatory system for some IVDs allows

for a self-certification procedure, placing heavy responsibility on manufacturers.

Non self-certified products are subject to the same

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

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.

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.

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chikungunya triplex tests.

Recently, 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.

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 self-certify certain of our products and affix a CE-marking for sales of our products in countries

accepting the CE marking (not in the United States) with only minimal further governmental approvals and registrations in most countries.

Food and Drug Administration (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”).

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.

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

the CLIA labs are able to use our test as it is or further validate our COVID-19 or other tests as Laboratory Developed Tests (LDTs),

which refers to a diagnostic test that has been validated for use in the CLIA lab.

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).

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.

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.

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.

The FDA has publicly announced its intention to regulate certain LDTs in a phased-in approach, but draft

guidance that was published a couple of years ago was withdrawn at the end of the Obama administration and replaced by an informal non-enforceable

discussion paper reflecting some of the feedback that it received on LDT regulation.

We are currently marketing our Logix Smart™

COVID-19 test to CLIA laboratories throughout the US.

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 for our tests changed radically with the emergence of the COVID-19 pandemic.

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and produce a quality product, we have been able to build a distribution network that extends to

more than 80 countries with over 50 active distributors, most of which have been the sales network that has allowed us to export products

throughout the world.

We believe that after the pandemic is brought under control, the network of distributors that we have built

in these extra-ordinary times will serve us well in sales of other diagnostic tests.

more than 80 countries with over 50 distributors, most of which have been the sales network that has allowed us to export products throughout

We believe that after the pandemic is brought under control, the network of distributors that we have built in these

extraordinary times will serve us well in sales of other diagnostic tests.

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

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Vector Control Services

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

Municipalities in the US and many other countries in the world are concerned about the diseases carried by mosquitos and which

infect the human population.

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,

the municipalities conduct mitigation operations to eliminate the mosquito populations carrying the diseases.

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, the solution is to 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.

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.

first vector related test was a triplex test that tests for West Nile, western equine and St.

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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, which saves our customers money.

Additionally, the districts are more effective because they can

get test results in a matter of hours using our product instead of weeks when they might otherwise have to wait for a central lab to

process the mosquito tests.

have sold our Vector Smart 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.

Advantages of Co-Diagnostics

believe that we have the following competitive advantages:

Affordability:

test kits and low-cost MDx-device.

CODX’s tests have been designed to run on many vendors’ DNA/RNA diagnostic testing machines.

are particularly well suited to the new generation of “lab-on-a-chip” and “point-of-care” (“LOC and

POC”), highly portable analysis machinery for field, clinical and office applications.

We believe our rapid assay design system software provides shorter time to product release.

This has been demonstrated with the

conception, design, product manufacture, clinical verification and submission for a CE Mark for our Logix Smart™ coronavirus

disease (COVID-19) test being approximately 30 days.

We believe our technology allows us to build tests that are highly sensitive and specific, the two benchmarks for accuracy in PCR

We project that rising health care costs in developed and developing nations will increasingly require that health

care systems be patient-specific to eliminate waste, misdiagnoses, and ineffectiveness.

A critical component will be accurate,

more affordable DNA-based diagnostics, especially in at-home and POC settings, which we plan to offer.

Low-cost Provider :

Our platform technology obviates the need to pay patent royalties typically required of our competitors, which use patented test

platforms to design their tests.

Worldwide Footprint :

With a dynamic technology that encompasses markets worldwide, we anticipate that we can identify the best target markets, not

only in high burden developing countries but also in developed nations.

Growth Industry Category :

We believe that DNA/RNA testing is the fastest-growing segment of in-vitro diagnostic testing.

Product Offering :

Our sensitive tests can be a well-designed match for a new generation of handheld and other small POC devices

now entering the market, including our own MDx and YourTest PCR™ devices.

Used together, these affordable tests and

devices may revolutionize the molecular diagnostics industry in cost, speed of test results and simplification.

Multiplexing:

existing multiplexed tests demonstrate that our CoPrimer-designed tests are able to test for multiple targets in the same sample

without the distortion caused by false negatives and false positives that often occur in multiplexed 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.

have sold our Vector Smart™ 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.

Biopsy for Cancer Screening

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

The project was undertaken in conjunction with the manufacturer of our CoPrimer tests.

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™”.

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”.

Licensing and Assay Development

addition, the unique properties of our CoPrimer technology make them ideally suited to a variety of applications where sensitivity is

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.

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Because of 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,

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.

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

Five of our initial U.S.

patents related to our technology have been granted by the U.S.

Patent and Trademark Office (PTO),

including the patent for our CoPrimer technology, which we consider our most important patent.

One of our patents has been issued in

Great Britain but still pending in the United States, and another has been granted in South Korea.

As of March 2022, we have an issued

patent in Great Britain and India on “Rapid Oligo Probes.” We also have an issued patent in the U.S.

on “Primers for

Nucleic Acid Extension or Amplification Reactions.” We have another issued patent in the U.S.

on “Detection of Primers for

Nucleic Acid Extension or Amplification Reactions.” We have 3 patents issued in the US, as well as patents issued in Australia,

Korea, and Mexico on “Cooperative Primers, Probes, and Applications Thereof.” We have applications pending in Australia,

Canada, Europe, and the U.S.

for “Methods and Compositions for Next Generation Sequencing (NGS) Library Preparation.” We

have applications pending in the U.S.

and internationally as a PCT application for “Allele-Specific Design of Cooperative Primers

for Improved Nucleic Acid Variant Genotyping.” Lastly, we have a provisional application on file in the U.S.

and Compositions Related to Cooperative Primers and Reverse Transcription.

have identified additional applications of the technology, which represent potential patents that further define specific applications

of the processes that are covered by the original patents.

We intend to continue building our intellectual property portfolio as development

continues and resources are available.

have copyrighted our development software that is used by us to develop diagnostic tests based on our technology.

had certain customers which were each responsible for generating 10% or more of our total revenue for the year ended December 31, 2021.

Two customers together accounted for approximately 48% of total revenue for the year ended December 31, 2021.

These customers may not

account for the same percentage of sales in future periods.

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.

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:

Affordability:

Lower-cost test kits, a low-cost MDx-device, and an affordable Co-Dx PCR Home platform for at-home and point-of-care testing

(the platform is subject to FDA review and not available for sale at the time of this filing).

CODX’s tests have been designed to run on many customers’ DNA/RNA diagnostic testing machines.

Our technology

is well suited to the new generation of point-of-care testing (“POCT”), compact and portable analysis machinery for field,

clinical and office applications.

We believe our rapid assay design system software provides shorter time to product release.

This has been demonstrated with the

conception, design, product manufacture, clinical verification and submission for a CE Mark for our Logix Smart COVID-19 test being

approximately 30 days.

We believe our technology allows us to build tests that are highly sensitive and specific, the two benchmarks for accuracy in PCR

We project that rising health care costs in developed and developing nations will increasingly require that health

care systems be patient-specific to eliminate waste, misdiagnoses, and ineffectiveness.

A critical component will be accurate, more

affordable DNA-based diagnostics, especially in at-home and POCT settings, for which we are developing products.

Our platform technology obviates the need to pay patent royalties typically required of our competitors, which

use patented test platforms to design their tests.

With a dynamic technology that encompasses markets worldwide, we anticipate that we can identify the best target

markets, not only in high burden developing countries but also in developed nations.

Industry Category :

We believe that real-time PCR testing is the fastest-growing segment of in vitro diagnostic testing.

Product Offering :

Our sensitive tests can be a well-designed match for a new generation of compact and other small POCT devices

now entering the market, including our own MDx and Co-Dx PCR Home devices.

Used together, we believe these affordable tests and devices

have the potential to revolutionize the molecular diagnostics industry in cost, speed of test results and simplification.

Multiplexing:

Our existing multiplexed tests demonstrate that our CoPrimer-designed tests are able to test for multiple targets in the

same sample without the distortion caused by false negatives and false positives that often occur in multiplexed tests.

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.

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 ™ 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.

had certain customers which were each responsible for generating 10% or more of our total revenue for the years ended December 31, 2022

and 2021, respectively.

One customer accounted for approximately 37% of total revenue for the year ended December 31, 2022 and two customers

together accounted for approximately 48% of total revenue for the year ended December 31, 2021.

These customers may not account for the

same percentage of sales in future periods.

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.

molecular diagnostics industry is extremely competitive.

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financial resources.

Because 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 respect from the medical and testing professionals, although 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.

In the diagnostic

testing industry, 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.

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

is, and will likely continue to be, particularly intense in the market for COVID-19 diagnostic tests.

Numerous companies in the United

States and internationally have announced their intention to offer new products, services and technologies that could be used in substitution

for our Logix Smart™ COVID-19 tests.

Many of those competitors are significantly larger, and have substantially greater

financial, engineering and other resources, than our company.

Existing and potential competitors in the market for COVID-19 diagnostic

tests include developers of serological, antigen and molecular tests.

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.

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.

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.

has been particularly intense in the market for COVID-19 diagnostic tests.

Numerous companies in the United States and internationally

have announced their intention to offer new products, services and technologies that could be used in substitution for our Logix Smart

COVID-19 tests.

Many of those competitors are significantly larger, and have substantially greater financial, engineering and other resources,

than our company.

Existing and potential competitors in the market for COVID-19 diagnostic tests include developers of serological, antigen

and molecular tests.

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.

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

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COVID-19 test to CLIA labs in the United States.

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 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.

We are in the process of registering for sale our Logix Smart™

COVID-19 and other tests in a number of major countries around the world.

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.

We are in the process of registering for sale our Logix Smart COVID-19 and other tests in a number of major countries

around the world.

of December 31, 2022, we had 145 full-time and part-time employees at our executive offices and lab facilities in Salt Lake City, Utah.

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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

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were incorporated as Co-Diagnostics, Inc., in Utah on April 18, 2013.

Our principal executive office is located 2401 S.

Our principal executive office is located at 2401 S.

Foothill Drive,

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

of Being an Emerging Growth Company

are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012.

We will remain an emerging

growth company until the earlier of (i) the last day of the fiscal year following the fifth anniversary of July 12, 2017, the date of

the first sale of our common stock pursuant to an effective registration statement under the Securities Act of 1933, as amended (the

“Securities Act”);

(ii) the last day of the fiscal year in which we have total annual gross revenues of $1 billion or more;

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years;

or (iv) the date

on which we are deemed to be a large accelerated filer under applicable SEC rules.

We expect that we will remain an emerging growth company

for the foreseeable future, but cannot retain our emerging growth company status indefinitely.

We refer to the Jumpstart Our Business

Startups Act of 2012 herein as the “JOBS Act”.

For so long as we remain an emerging growth company, we are permitted and

intend to rely on exemptions from specified disclosure requirements that are applicable to other public companies that are not emerging

growth companies.

These exemptions include:

permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements,

with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”

being required to comply with the requirement of auditor attestation of our internal controls over financial reporting;

being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory

audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial

disclosure obligations regarding executive compensation;

being required to hold a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments

not previously approved.

as long as we continue to be an emerging growth company, we expect that we will take advantage of the reduced disclosure obligations

available to us as a result of that classification.

Accordingly, the information contained herein may be different than the information

received from other public companies.

emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for

complying with new or revised accounting standards.

This allows an emerging growth company to delay the adoption of certain accounting

standards until those standards would otherwise apply to private companies.

We have irrevocably elected to avail ourselves of this extended

transition period and, as a result, we will not be required to adopt new or revised accounting standards on the dates on which adoption

of such standards is required for other public reporting companies.

are also a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the

Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companies.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business