What changed in this filing

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Item 1. Business

2024-03-14 compared with 2023-03-16 · 220 added, 171 removed, 241 unchanged (62% of the section changed)

Co-Diagnostics,

Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic

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

tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications.

In connection with the

sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems (which we refer to as the “MDx

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

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

and even at-home settings.

This platform is subject to U.S.

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

for sale at the time of this filing.

There is no guarantee that our Co-Dx PCR Home platform will receive the necessary regulatory approvals

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

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

complex procedures in both the development and administration of tests.

CODX’s technical advance involves a novel, patented approach

to PCR test design of primer and probe structure (“CoPrimers™”) that eliminates one of the key vexing issues of PCR

amplification:

the exponential growth of primer-dimer pairs (false positives and false negatives) which adversely interferes with identification

of the target DNA/RNA.

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,

hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus.

These initial diagnostic tests were cleared

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

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.

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

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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

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rapidly screen millions of possible options to pinpoint the optimum design.

Brent Satterfield, our founder, developed the intellectual

property we use in our business, consisting of the predictive mathematical algorithms and patented molecular structure used in the testing

process, which together represent a major advance in PCR testing systems.

CODX technologies are now protected by more than 20 granted

or pending US and foreign patents, as well as certain trade secrets and copyrights.

Ownership of our proprietary platform permits us

the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow the sale of diagnostic PCR

tests at a lower price than competitors, while enabling us to maintain profit margins.

The intellectual property we use in our business, consisting

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

advance in PCR testing systems.

CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well

as certain trade secrets and copyrights.

Ownership of our proprietary platform permits us the advantage of avoiding payment of patent

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

enabling us to maintain profit margins.

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

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

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

comprise our proprietary tests to those laboratories and testing facilities.

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

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

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.

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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.

We, in conjunction with our customers, are active in designing

and licensing 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.

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

need for detection of the virus.

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

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

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

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

Utah-based ISO-13485:2016 certified facility.

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

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

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

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

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

labs since that time.

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

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

We believe this may be accomplished

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

results in around 30 minutes.

The initial project built on this platform, an at-home and point-of-care COVID-19 PCR test, was ultimately

facilitated by our development of a saliva or nasal swab-based PCR test that does not require the RNA/DNA extraction.

While we believe

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

PCR test has the advantages of increased speed and ease of handling thanks to lyophilization (or freeze-drying) of our testing reagents

to allow for stability at room temperatures.

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

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

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

related to the platform and device.

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

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

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

The device would

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

the marketplace.

All such tests will be subject to regulatory approval.

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

Because the evaluations

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

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

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.

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.

Disease Product Offering

Using our proprietary test design system and proprietary reagents, we and

CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture for manufacturing in India, design and sell PCR diagnostic tests

for detection of diseases and pathogens such as COVID-19, influenza, tuberculosis, hepatitis B and C, malaria, dengue, human papillomavirus,

chikungunya, and Zika virus, all of which tests have been designed and verified in our laboratories.

Our tuberculosis test and Zika test

received a CE Mark in 2018, and a triplex test for Zika, dengue and chikungunya received a CE Mark in 2019, qualifying the tests to be

sold throughout the European community and in most countries in Central and South America.

In December 2019, CoSara received a license

to manufacture and sell tuberculosis, hepatitis B, hepatitis C, human papillomavirus 16/18 and malaria tests in India from the Central

Drugs Standard Control Organization (“CDSCO”).

In February 2020, we received a CE Mark for our Logix Smart COVID-19 test followed

by an EUA by the FDA in April 2020.

Also, in April 2020, our COVID-19 test was approved for manufacture and sale in India by the CDSCO

and in Mexico by the INDRE, Mexico’s equivalent to the United States Center for Disease Control.

In August 2020, we received approval

from the Australian Department of Health Therapeutic Goods Division to sell our COVID-19 test in Australia.

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.

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.

Also, in April 2020,

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

the United States Center for Disease Control.

In August 2020, we received approval from the Australian Department of Health Therapeutic

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

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

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

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

hands of medical professionals in a timely manner.

It can be similarly used to design a test for mutated strains of the virus should

they not be detectable using currently available tests.

and Central and South America

began selling PCR diagnostic tests to entities located in South and Central America and the Caribbean in 2018.

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

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.

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.

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

test for Zika, chikungunya, and dengue.

Sales of those tests have not been material, but with the granting of a CE mark for our Logix

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

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

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Indian market.

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

The Company has

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

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

The placement of thermocyclers in

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

The WHO 2019 Global Tuberculosis Report indicates that India

is the country with the highest number of cases of tuberculosis in the world.

WHO tuberculosis statistics for India for 2018 give an

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

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

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.

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.

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.

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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chikungunya triplex tests.

Recently, the European Commission has revised its directive governing the CE- marking of IVDs, which included

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.

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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.

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.

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.

CLIA laboratories

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

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

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

Because we were able to respond rapidly

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

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

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

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

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.

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

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the tests designed, they will need to seek a commercial license directly from us.

Because of these unique characteristics of CoPrimers,

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

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

Competitive Advantages of Co-Diagnostics

We believe that we have the following competitive advantages:

Advantages of Co-Diagnostics

believe that we have the following competitive advantages:

Affordability:

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

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

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

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.

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

use patented test platforms to design their tests.

use third-party patented test platforms to design their tests.

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

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

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.

Industry Category :

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

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

Used together, we believe these affordable tests and devices

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

now entering the market, including our own MDx and Co-Dx PCR Pro instruments.

Used together, we believe these affordable tests and

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

Multiplexing:

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

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

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

31, 2023 and 2022, respectively.

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

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

These customers may not account for the

same percentage of sales in future periods.

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

to replace those customers with others.

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.

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

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

Numerous companies in the United States and internationally

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

COVID-19 tests.

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

than our company.

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

and molecular tests.

We also compete with companies from Asia in certain markets who are willing to sell their tests for much less than

we sell our tests, which creates competitive price pressure on us in certain regions, particularly Asia and Latin America.

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.

The entrance of new competitors is being encouraged by governmental authorities,

who are offering funding to support development of testing solutions for COVID-19.

Some of our existing or new competitors may have strong

17 unchanged sentences

to sell in Australia.

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

around the world.

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

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

of independent sales representatives on an “as needed” basis.

We consider our people and the way we work to support each other and serve

our customers to be critical to our success.

The key human capital measures and objectives that we focus on in managing our business are:

maintaining a strong and collaborative company culture, increasing our diversity, inclusion and belonging, offering fair and competitive

compensation and benefits, investing in people and organizational development, protecting and enriching employee health and wellness,

and sustaining a culture of respectful and effective communications.

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

independent sales representatives on an “as needed” basis.

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

The key human capital

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

maintaining a strong and collaborative company culture, increasing

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

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

Organizational

9 unchanged sentences

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