What changed in this filing

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Item 1. Business

2025-03-27 compared with 2024-03-14 · 319 added, 336 removed, 125 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.

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 (“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.

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,

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.

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.

technical advance involves a novel, proprietary approach to PCR test design of primer and probe structure (“Co-Primers ® ”)

that dramatically reduces one of the key vexing issues of PCR amplification:

the exponential growth of primer-dimer amplification (false

positives) which adversely interferes with identification of the target DNA/RNA.

Using our proprietary test design system and 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

These initial diagnostic tests are cleared

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

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

The system is comprised of our PCR instrument that we refer to as the Co-Dx™ PCR Pro™ 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-Dx™ 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.

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-Dx™ PCR Pro™ instrument, our patent-pending 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-Dx™

PCR platform which has been 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

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.

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.

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

Food and Drug Administration (“FDA”) review

and is not available for sale at the time of this filing.

In June 2024, we completed our first U.S.

Food and Drug Administration (FDA)

application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile

app for over-the-counter (OTC) use.

Following productive engagement with the FDA related to the regulatory submission, the Company withdrew

its 510(k) application.

The decision to withdraw the submission was based on discussions with the FDA regarding the ability to detect

a potential deterioration of one component of the test, related to shelf-life stability.

Following dialogue with the FDA and exploring

the various courses of action available, we determined that the best long-term solution would be to submit a version of the test that

has been enhanced to address the matter raised in the 510(k) review process.

The Company plans to submit the next iteration of the Co-Dx

PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance.

A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx

believes will also help create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize

the next generation of test kits and instruments across all tests on the at-home and point-of-care Co-Dx PCR platform.

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.

believe our proprietary and patented 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 CE marking for regulatory clearance

in a period of just over 30 days.

This is a real-world example of how 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 SARS-CoV-2 or other viruses should they not be detectable using currently available tests.

addition, continued development has demonstrated the unique properties of our Co-Primers 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

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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

The intellectual property we use in our business consists

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

advance in PCR testing systems.

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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

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

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

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

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”).

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.

our proprietary test design system and 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 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 cleared for sale in countries

such as the United Kingdom, Australia, India, 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, including

an OEM’s PCR instrument which we refer to here as the “Co-Dx Box”.

In addition to testing for infectious disease, Co-Primers 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.

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

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.

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

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-Primers™ 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 ½” x 4 1/2” x 6”, 2

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.

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

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.

have commercialized three multiplexed tests to test mosquitos for the presence of diseases they carry, which enables municipalities to

concentrate their efforts in managing mosquito populations in specific areas where mosquitos carrying deadly viruses are known to breed.

believe the benefits of affordable, high-quality diagnostics should be available to everyone.

High-quality point-of-care polymerase chain

reaction (“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, reducing turnaround time to results, and

allowing for immediate decision-making.

Gold-standard 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-Primers™

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 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 platform comprised of a compact, relatively low-cost testing

device, the Co-Dx PCR Pro instrument, together with patent-pending diagnostic test cups that work with the instrument and an intuitive

mobile application, that is easy to use by professionals and non-professionals, all of which can provide PCR test results in around 30

As user test results are analyzed and anonymized in the cloud, we believe this data may be useful for governmental health agencies

and the World Health Organization to determine where outbreaks of infectious diseases may be occurring and to enable them to act more

quickly and efficiently to slow-down or perhaps even prevent further spread.

6 ½” 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, from sample swab collection to the straightforward instrument operation.

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

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 (standard in laboratory-based PCR

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

COVID-19 PCR platform test has the advantages of increased speed over clinical laboratories, with results in around 30 minutes compared

to hours or even days, and ease of handling thanks to lyophilization (or freeze-drying) of our testing reagents to allow for storage

at room temperatures.

In December 2023, we submitted our proprietary Co-Dx PCR COVID-19 test cups, together 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).

In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx

PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use.

Following productive engagement

with the FDA related to the regulatory submission the Company withdrew its 510(k) application.

The decision to withdraw the submission

was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related

to shelf-life stability.

Following dialogue with the FDA and exploring the various courses of action available, we determined that the

best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review

The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection

of clinical evaluation data to support the new test’s performance.

A new submission will also allow the Company to incorporate

more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help create greater operational and

manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments

across all tests on the at-home and point-of-care Co-Dx PCR platform.

expect to develop further diagnostic tests for use with the PCR Pro instrument, including a multiplex test for influenza A and B, RSV

and COVID-19.

To that effect, in July 2023 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 development of our upper respiratory panel diagnostic test for

use on the Company’s Co-Dx PCR platform.

We are utilizing 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.

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.

We have been awarded two grants totaling $6.8

million for the TB test and one grant totaling $987,000 for the HPV test by the Bill & Melinda Gates Foundation to support the development

and manufacture of these 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

The WHO reported a worldwide gap of roughly 2.7 million unidentified cases between the reported number of newly diagnosed

TB cases in 2023 and the estimated number of incident 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

The National Cancer Institute estimates that high-risk HPVs cause roughly 5% of all cancers worldwide, including cervical

cancer, the fourth most common cancer in women and which led to an estimated 350,000 cervical cancer deaths in 2022 according to the

About 94% 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.

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, 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”).

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

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

for development and 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 tests received CE marking in 2018, and a triplex test

for Zika, dengue and chikungunya received CE marking 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 CE marking for our Logix Smart COVID-19 test followed by an EUA by the FDA in April 2020.

Also, in April

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.

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.

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

in vitro diagnostic or IVD in countries that accept CE marking for regulatory clearance in a period of just over 30 days.

is a real-world example of how 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 SARS-CoV-2 or other viruses

should they not be detectable using currently available tests.

and Central and South America

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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.

there are limited regulatory hurdles, which allowed us to begin offering our tests immediately with CE markings.

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, 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.

Sales of those tests have not been material, but with the granting of CE marking and EUA 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 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 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.

manufacturing company in India and formed CoSara Diagnostics Pvt.

as a 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.

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.

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 14 of those tests under the SaraGene brand.

The Company manages a reagent rental program in India with

thermocyclers purchased from a third-party manufacturer and which we refer to here as our Co-Dx Box.

The placement of thermocyclers

in India has facilitated the sale of the SaraGene PCR tests in India.

The WHO 2024 Global Tuberculosis Report indicates that India

was the country with the highest number of cases of tuberculosis in the world in 2023, with 26% of an estimated global incidence of

approximately 10.8 million cases.

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

10 unchanged sentences

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.

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).

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.

The regulatory system for some IVDs 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 receiving CE marking.

is a manufacturer’s declaration that a product meets the requirements of the applicable European Commission (EC) directive.

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 bear a CE marking, as an indication that the product is compliant with EU legislation and

sold in the European Union.

We have received CE marking 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.

In May 2022, the EC published the In Vitro Diagnostic Regulation (IVDR), a new regulation that significantly revised the

requirements for CE marking of IVDs.

To avoid potential shortages of essential healthcare products, the EC extended the transition deadlines

Co-Dx is actively pursuing CE-IVD compliance under IVDR through the Annex IX route to conformity.

For manufacturers actively

pursuing IVDR compliance, European regulators have allowed a grace period until 2028 for Class B devices to harmonize their devices and

Quality Management Systems (QMS) with the new regulation.

Co-Diagnostics

PCR tests are manufactured under an ISO 13485:2016 certified quality management system, 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, subject to the requirements in the updated directive mentioned above.

801(e) of the Federal Food, Drug, and Cosmetic Act, as amended (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 for any of our Logix Smart PCR tests.

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, and grants Co-Diagnostics permission

to export all of our IVD products.

We have received EUA clearance for our Logix Smart 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 overseas customers and to CLIA certified laboratories in the United

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

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.

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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.

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

has allowed us to export products throughout the world.

We anticipate that our network of distributors that we have built over

the past five years will serve us well in sales and distribution of other diagnostic tests and our forthcoming PCR diagnostic platform.

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, 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.

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

response to market demand, in June 2019 we introduced our first Vector Smart ® PCR tests to be used exclusively 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.

is too expensive and potentially harmful to the environment to treat all mosquito breeding areas, municipalities may identify and focus

their efforts on particular areas with 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.

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 encephalitis and St.

Louis encephalitis.

We began shipping the

tests in June 2019.

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.

in November 2019, we completed a test for West Nile, eastern equine encephalitis 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 also allow municipalities to obtain test results in-house in a

matter of hours, instead of the days or 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

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.

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.

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

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 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”.

Licensing and Assay Development

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.

Advantages of Co-Diagnostics

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Affordability:

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

Lower-cost test kits, a low-cost Co-Dx Box, and an affordable Co-Dx PCR 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).

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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.

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.

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

(under the previous directive) 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

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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 third-party patented test platforms to design their tests.

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

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

which use third-party patented test platforms to design and manufacture 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.

Data Collection :

With the anticipated deployment

of the Co-Dx PCR platform we expect to play a role in centralizing global data collection on infectious diseases that may contribute

to faster vaccination and therapeutic responses from health authorities.

markets, not only in low-to-middle income countries but also in developed nations.

With the anticipated deployment of the Co-Dx PCR platform we expect to play a role in centralizing global data

collection on infectious diseases that may contribute to faster vaccination and therapeutic responses from health authorities.

Industry Category :

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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 Pro instruments.

Our 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 Co-Dx Box and Co-Dx PCR Pro instrument.

Used together, we believe these affordable tests and

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Multiplexing:

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

Our existing multiplexed tests demonstrate that our Co-Primers-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.

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of critical importance.

Currently, our flagship CoPrimers technology is covered by two U.S.

Currently, our flagship Co-Primers technology is covered by two U.S.

patents titled “Cooperative primers,

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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.

which is the basis of our at-home and point-of-care PCR platform.

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

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31, 2024 and 2023, 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.

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.

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.

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.

One customer accounted for approximately 31% of product revenue for the year ended December 31, 2024

and two customers accounted for approximately 27% of product revenue for the year ended December 31, 2023.

Two granting agencies accounted

for approximately 95% of grant revenue for the year ended December 31, 2024, and 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.

The molecular diagnostics industry is extremely competitive.

many firms that provide some or all of the products we provide and provide many diagnostic tests that we have yet to develop.

these competitors are larger than us and have significantly greater financial resources.

Many of our competitors have a competitive advantage

in the diagnostic testing industry because they also have other lines of business in the diagnostics, pharmaceutical, or biotech industries

from which they derive revenues and for which they are well known and respected in the medical profession.

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, Roche Diagnostics 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.

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.

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.

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

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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.

The Company operates under an ISO 13485:2016 certified quality management system, relating

to the design and manufacture of our medical device products.

Being ISO certified greatly facilitates our applications for regulatory

clearance, including CE marking, which allows us to sell any tests 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 clearance to sell our Logix Smart COVID-19 test in Australia.

of December 31, 2024, we had 132 full-time and part-time employees at our executive offices and lab facilities in Salt Lake City, Utah.

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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