What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-03-27 · 276 added, 242 removed, 202 unchanged (72% of the section changed)

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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 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 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.

tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including 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.

CODX’s technical

advance involves a novel, proprietary approach to polymerase chain reaction (“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 are cleared for use in clinical labs only and not for point-of-care or at-home use.

have developed a 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 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.

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 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 engagement

with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical

approach for detecting potential degradation of a test component over its intended shelf life.

While the Company believes that the matter

identified during the review process could have been addressed through additional development and clinical validation activities, management

determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward

development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (“ABCR”).

Moving focus to this

test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process.

believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive

upper respiratory infection testing in point-of-care settings.

Accordingly, clinical performance studies for the ABCR test are currently

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

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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

for regulatory approval and ready to be used as an in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance

in a period of just over 30 days.

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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

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

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

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

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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.

royalties required by other PCR test systems, which may allow for 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 pairing the locations

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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.

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.

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.

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

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

India (along with our joint venture, CoSara) 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.

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™”.

addition to testing for infectious diseases, 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

tests that identify genetic traits in plant and animal genomes.

We also 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.

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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.

influenza 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

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and helps control the spread of infectious diseases.

That is why we are developing the Co-Dx PCR platform utilizing our Co-Primers™

That is why we have developed 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.

Because we believe that testing for upper respiratory 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, pharmacies and the

hospitality industry.

Our Co-Dx PCR Pro platform is comprised of a compact, relatively

low-cost testing device, the Co-Dx PCR Pro instrument, together with 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 minutes.

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.

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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 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 testing).

The final result was believed to be approximately equivalent

to those processed by a high-complexity clinical laboratory.

Our COVID-19 PCR platform test had 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 engagement with the FDA during the review process, the Company voluntarily withdrew the

510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its

intended shelf life.

While the Company believes that the matter identified during the review process could have been addressed through

additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19

test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19,

RSV multiplex test (“ABCR”).

Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments

into the design and test manufacturing process.

Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better

aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings.

Accordingly, we announced

on November 17, 2025 that the clinical performance studies for the ABCR test were underway.

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.

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 have utilized the funds from the RADx Tech award to complete development of our flu A/B, COVID-19, and RSV multiplex

test, in preparation for the clinical performance testing on the Co-Dx PCR Pro instrument, which began in November 2025.

The NIH launched

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Disease Product Offering

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

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.

our proprietary test design system and patented Co-Primers, we and CoSara Diagnostics Pvt Ltd (“CoSara”), our 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.

The Co-Dx Logix Smart® Mycobacteria Tuberculosis (MTB)

test and Logix Smart Zika test received CE marking in 2018, and for the Logix Smart Zika, dengue and chikungunya (ZDC) multiplex

test received CE marking in 2019, qualifying the tests to be sold throughout the European community and in most countries in Central

and South America (subject to local registration requirements).

In December 2019, CoSara received a license from the Central Drugs

Standard Control Organization (“CDSCO”) to manufacture and sell tuberculosis, hepatitis B, hepatitis C, human

papillomavirus 16/18 and malaria tests in India.

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 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

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.

in vitro diagnostic (“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

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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 CE marking and EUA for

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

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

our triplex test for Zika, chikungunya, and dengue.

Sales of those tests have been modest, 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

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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.

The agreement provided for the construction of a manufacturing plant, the manufacture of the PCR tests using the

Company’s primer technology, 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

The CDSCO has issued clearances for 15 laboratory-based PCR tests to be sold by CoSara as IVDs, 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.

Those tests in India

are branded as SaraGene COVID-19 tests and are sold exclusively by CoSara.

The Indian government places restrictions on the price that

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

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

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

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

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

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

The Company manages a reagent rental program in India with thermocyclers

purchased from a third-party manufacturer, the Co-Dx Box.

The placement of thermocyclers in India has facilitated the sale of the SaraGene

PCR tests in India.

The WHO 2025 Global Tuberculosis Report indicates that India was the country with the highest number of cases of

tuberculosis in the world in 2024, with 25% of an estimated global incidence of approximately 10.7 million cases.

received authorization to manufacture and sell COVID-19 tests in India.

Those tests in India are branded as SaraGene COVID-19 tests and

are sold exclusively by CoSara.

The Indian government places restrictions on the price that could be charged for COVID-19 tests which

limited the revenue in India more than we experienced in other parts of the world.

At the time of this report, CoSara has received CDSCO

clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C (including viral load tests for both hepatitis

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

test, an influenza A/influenza B/COVID-19 (“ABC”) multiplex test, and in 2024 CDSCO cleared the manufacture and sale of the

SARAPLEX™ Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic for the detection and differentiation

of Influenza A and Influenza B.

Additionally, in 2026, CoSara received a license from CDSCO to manufacture the CoSara PCR Pro ®

real-time PCR point-of-care instrument for sale or distribution.

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

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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

We have received CE markings 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 In Vitro Diagnostic Regulation (IVDR), a new regulation that significantly revised the requirements

for CE marking of IVDs, became effective.

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

deadlines in 2024.

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.

For manufacturers

actively pursuing IVDR compliance, European regulators have allowed a grace period until 2029 for Class B devices to harmonize their

devices and Quality Management Systems (QMS) with the new regulation.

Co-Diagnostics

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products, subject to the requirements in the updated directive mentioned above.

October 2025, we entered into a definitive agreement with Arabian Eagle Manufacturing, a regional manufacturing and distribution company

based in the Kingdom of Saudi Arabia (“KSA”) to form CoMira Diagnostics (“CoMira”), a joint venture dedicated

to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including the

Company’s upcoming Co-Dx™ PCR point-of-care platform, within KSA and 18 other countries throughout the Middle East and North

Africa (“MENA”).

CoMira’s mission aligns with the key pillars of Saudi Vision 2030, supporting technology localization,

industrial diversification, and healthcare innovation, as the new venture engages in research, development, manufacturing, assembly,

distribution, and commercialization of Co-Dx products.

CoMira believes that initially pursuing regulatory clearance with the

Saudi Food & Drug Administration (“SFDA”) will also directly facilitate entry into many of the other 18 MENA countries

included in the agreement, consisting of:

Bahrain, Iraq, Jordan, Kuwait, Lebanon, Oman, Palestine, Qatar, Syria, Turkey, United Arab

Emirates (UAE), Yemen, Algeria, Egypt, Libya, Morocco, Sudan and Tunisia

Arabian Eagle was the Company’s primary distributor in the Middle East and was instrumental in KSA being one of the largest international

markets for the Company’s Logix Smart® tests.

Similar to the Company’s partnership in India with CoSara, Co-Dx will provide

CoMira an exclusive license to use, manufacture, and commercialize the licensed IP, which will include the upcoming Co-Dx PCR platform

as well as the Company’s existing suite of lab-based PCR diagnostic products.

We believe that our cutting-edge PCR technology,

along with the scope and mission of CoMira, addresses the key demand drivers for growth published by KSA while reinforcing our resolve

to close the accessibility gap between high-quality PCR diagnostics and those who need them.

801(e) of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDA Act”) covers certain medical devices that have not

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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.

approval of 510(k) submission 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.

to pursue all appropriate FDA review pathways for products under development, including traditional premarket review pathways.

our EUA, we continue to sell our Logix Smart COVID-19 test to overseas customers and 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.

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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.

the past six 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.

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

These advantages

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

individual genes.

There are several advantages of PCR tests over other forms of diagnostic testing.

These advantages include higher specificity and sensitivity,

the ability to perform multiplex tests and the ability to test for drug resistance or for individual genes.

Vector Control Services

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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.

Municipalities in the US and many other countries in the world are concerned about the infections

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 treat all mosquito breeding areas, municipalities may identify

and focus their efforts on particular areas with mosquitos that are carrying these harmful viruses.

To know where the host mosquitos

with 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 the Vector Smart NAM-w triplex test for West Nile, western equine encephalitis and St.

Louis encephalitis.

shipping the tests in June 2019.

We began shipping the tests in June 2019.

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

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.

Finally, in November 2019, we completed the Vector Smart NAM-e 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.

Advantages of Co-Diagnostics

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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.

lab-based 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.

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A critical component will be accurate, more

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

affordable molecular diagnostics, especially in at-home and POCT settings.

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

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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.

With the anticipated deployment of the Co-Dx PCR platform we expect to play a role in decentralized diagnostics,

while 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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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.

same sample without the distortion caused by 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

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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 platform.

We intend to continue building our patent portfolio as development

continues and resources are available.

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

In December 2025 we announced the first patent received for this

platform, granted by Australia (Patent No.

AU2022270084A1) .

This was followed by the announcement in March 2026 that the Japan Patent

Office had granted Patent No.

7797537, titled “Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis,”

which includes 34 claims covering the fundamental systems, methods, and apparatus of the Co-Dx PCR Pro ®

instrument and proprietary

test cups designed for use with the 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

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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.

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

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.

Company had certain customers which were each responsible for generating 10% or more of revenue for the years ended December 31, 2025

and 2024, respectively.

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.

agency accounted for 100% of grant revenue for the year ended December 31, 2025, and two granting agencies accounted for approximately

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

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.

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,

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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.

test, tuberculosis test, Zika virus test, a Zika, dengue, and chikungunya multiplex test, 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

We have also received clearance to sell our Logix Smart COVID-19 test in Australia.

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The key human capital

measures and objectives that we focus on in managing our business are:

maintaining a strong and collaborative company culture, increasing

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

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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