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Item 1. Business

2021-03-25 compared with 2020-03-30 · 311 added, 206 removed, 141 unchanged (79% of the section changed)

Co-Diagnostics,

Inc., a Utah corporation (“Company,”

or “CDI,”) is developing robust and innovative molecular tools for

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

We have developed and we

manufacture and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules

(DNA or RNA).

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”).

Inc., a Utah corporation (the “Company”

or “CDI”), is developing robust and innovative molecular tools

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

We develop, manufacture

and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or

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”).

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

complex procedures in both the development and administration of tests.

CDI’s newest technical advance involves a novel

approach to Polymerase Chain Reaction (“PCR”) test design (“Co-Primers”) 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.

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

through our enhanced detection of genetic material.

Because we own our platform, we are able to accomplish this faster and more

economically, allowing for wider margins while still positioning Co-Diagnostics to be a low-cost provider of molecular diagnostics

and screening services.

addition, continued development has demonstrated the unique properties of our Co-Primer technology that make them ideally suited

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

CDI’s technical advance involves a novel approach

to Polymerase Chain Reaction (“PCR”) test design of primer and probe structure (“CoPrimers”) that eliminates

one of the key vexing issues of PCR amplification, the exponential growth of primer-dimer pairs (false positives and false negatives)

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

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

research through our enhanced detection of genetic material.

Because we own our platform, we believe we will be able to accomplish

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

of molecular diagnostics and screening services.

addition, continued development has demonstrated the unique properties of our CoPrimer technology that make 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 gen sequencing.

scientists use the complex mathematics of DNA test design, to “engineer”

a DNA test and to automate algorithms that

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

Satterfield, our Chief Technology Officer, developed

the Company’s intellectual property consisting of the predictive mathematical algorithms and proprietary reagents used in

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

CDI technologies are now protected by seven

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 enables the sale of

diagnostic tests at a lower price than competitors, while generating a profit margin.

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

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

Satterfield, our founder, developed the Company’s

intellectual property consisting of the predictive mathematical algorithms and proprietary reagents used in the testing process,

which together represent a major advance in PCR testing systems.

CDI technologies are now protected by eight 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 enables the sale of diagnostic tests

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

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

that comprise our proprietary tests to those laboratories and testing facilities.

designed our tests by identifying the optimal locations on the target gene for amplification and paired the location with the

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

This is done by following planned and documented processes, procedures and testing.

In other words, the data resulting from our

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

Verification is a series of testing that concludes

that the product is ready to proceed to validation in a clinical evaluation setting using initial production tests to confirm

that the product as designed meets the user needs.

diagnostics systems enable very rapid, low-cost, sophisticated molecular testing for organisms and genetic diseases by greatly

automating historically complex procedures in both the development and administration of tests.

CDI’s newest technical advance

involves a novel approach to PCR test design (cooperative primers) 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.

its proprietary test design system and proprietary reagents, CDI has designed and obtained regulatory approval in the European

design our tests by identifying the optimal locations on the target gene for amplification and pair the location with the optimized

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

done by following planned and documented processes, procedures and testing.

In other words, the data resulting from our tests

verify that we succeeded in designing what we intended at the outset.

Verification is a series of testing that concludes that

the product is ready to proceed to validation in an evaluation either in our lab 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 proprietary reagents, we have designed and obtained regulatory approval in the European

Community and in India to sell PCR diagnostic tests for COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, malaria,

chikungunya, dengue, and the zika virus.

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

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

We are active in designing and licensing tests

that identify genetic traits in plant and animal genomes.

We also have a number of tests developed to test mosquitos for the identification

of diseases carried by the mosquitos to enable municipalities to concentrate their efforts in spraying 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 principle design work for a PCR screening test for new coronavirus, COVID-19,

intended to address potential need for detection of the virus.

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

for its COVID-19 test from the FDA and sells that test to qualified labs.

In addition, our LogixSmart COVID-19 test has been approved

for sale in Australia and Mexico by the regulatory bodies in those countries and has been registered for sale in many more countries.

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

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

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 spraying 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 screening test for the new coronavirus, COVID-19,

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

An outbreak of respiratory illness caused by the pneumonia-like

COVID-19 has spread rapidly over past few months, after first being discovered in the Chinese city of Wuhan on December 31, 2019.

COVID-19 has spread rapidly throughout the world since first being discovered in the Chinese city of Wuhan on December 31, 2019.

China confirmed human-to-human transmission of the virus and the United States announced the first infection in this country,

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Our COVID-19 test features the Company’s patented CoPrimer™

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

Centers for Disease Control.

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 20, 2020, we announced that our Logix Smart™

COVID-19 Test technical file had been submitted for registration with

the European Community, and that it was expected to be available late February as an in vitro diagnostic (“IVD”) for

markets that accept a CE marking as valid regulatory approval.

Subsequently, on February 24, 2020, we announced that our test

obtained regulatory clearance to be sold as an in vitro diagnostic for the diagnosis of SARS-CoV-2 (COVID-19) in markets that

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

certified facility.

The Declaration of Conformity for the Logix Smart COVID-19 test confirms that it meets the Essential Requirements

of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of

the product as an IVD to commence immediately in the European Community.

We shipped samples of the Research Use Only version of

our test to distributors in various countries, which allowed future customers to confirm the quality and sensitivity

of the product, and for us to accelerate the sales efforts of the COVID-19 test.

We commenced sales of the COVID-19

tests in February and March and have sold the tests in numerous countries around the world as well as sales to labs in the United

the European Union, and that it was expected to be available late February as an in vitro diagnostic (“IVD”) for markets

that accept a CE marking as valid regulatory approval.

Subsequently, on February 24, 2020, we announced that our test obtained

regulatory clearance to be sold as an IVD for the diagnosis of COVID-19 in markets that accept CE-marking as valid regulatory

approval, and became available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility.

The Declaration

of Conformity for the Logix Smart COVID-19 test confirms that it meets the Essential Requirements of the European Community’s

In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD in the European

We shipped samples of the Research Use Only version of our test to distributors in various countries, which allowed

future customers to confirm the quality and sensitivity of the product, and for us to accelerate the sales efforts of the COVID-19

commenced sales of the COVID-19 tests in February and March of 2020 to international customers and have since sold approximately

10,000,000 tests in numerous countries around the world through an expanding distributor network.

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

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

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

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

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

pandemic has subsided, we have initiated a project to facilitate frequent testing in schools, businesses, and the hospitality

We believe this may be accomplished through the development of a low cost, easy to use by non-professionals, testing

device that can provide PCR quality test results in less than an hour.

This project is possible due to the facts that in 2020

we were able to successfully lyophilize our Logix Smart Covid-19 test reagents and additionally developed a saliva-based collection

system that does not require the RNA/DNA extraction.

While the final result is the same as if done through a lab-based IVD process,

it has the advantages of increased speed and ease of handling thanks to lyophilization.

We have engaged the services of a group

of professionals who have the expertise to develop the hardware for such a device using our CoPrimers as the reagent chemistry.

The device will be available to homes, offices, event facilities, and the travel industry at a cost that will allow screening

frequently to prevent spread of the COVID-19 virus in the future.

The device would also be available to test for other pathogens

detectable through saliva samples as we develop those tests and offer them to the marketplace.

Disease Product Offering

its proprietary test design system and proprietary reagents, CDI designs and sells PCR diagnostic tests for diseases and pathogens

our proprietary test design system and proprietary reagents, we design and sell PCR diagnostic tests for diseases and pathogens

such as COVID-19, tuberculosis, hepatitis B and C, malaria, dengue, human papilloma virus, chikungunya, and Zika virus, all of

which tests have been designed and verified in CDI’s laboratory.

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 our test to be sold throughout

the European community and in most countries in central and South America.

In December, 2019, our Indian joint venture received

a license to manufacture and sell Tuberculosis, Hepatitis B, Hepatitis C, Human Papilloma virus 16/18 and Malaria tests in India

which tests have been designed and verified in our laboratory.

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, our Indian joint venture received a

license to manufacture and sell tuberculosis, hepatitis B, hepatitis C, human papilloma virus 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.

explained above, the development of our Logix Smart COVID-19 test was designed, developed, submitted for regulatory approved and

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

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

In August 2020, we received approval

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

explained above, the development of our Logix Smart COVID-19 test was designed, developed, submitted for regulatory approval and

ready to be used both as a Research Use Only (“RUO”) and as an IVD in countries that accept a CE Mark as approval

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It can be similarly used

to design a test for mutations of the virus should they occur.

to design a test for mutations of the virus should they occur and not be detectable using currently available tests.

and Central and South America

initial sales were to entities within the Caribbean Public Health Agency Members States (Anguilla, Antigua and Barbuda, Aruba,

Bahamas, Barbados, Belize, Bermuda, BES Islands, British Virgin Islands, Cayman Islands, Curacao, Dominica, Grenada, Haiti, Guyana,

Jamaica, Montserrat, Saint Kitts and Nevis, Saint Lucia, St Maarten, Saint Vincent and the Grenadines, Suriname, Trinidad and

Tobago, Turks and Caicos Islands).

some of these countries, there are no regulatory hurdles and we can start offering our tests immediately.

We have applied for

registration of our tests in those countries that require registration and our distributors in those countries have provided us

with in country assistance in completing such registrations.

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

In some of those countries, there are limited regulatory

hurdles so we started offering our tests immediately.

We have applied for registration of our tests in 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 test, followed quickly by tests for tuberculosis, our

triplex test for Zika, chikungunya, and dengue, hepatitis B and C, and dengue.

Products are manufactured for sale upon receipt

of purchase orders from labs and hospitals.

Company has entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing

company in India and formed an Indian joint venture which is CoSara Diagnostics, Pvt.

The agreement provides for the construction

of a manufacturing plant and the manufacture of the tests named above and the joint sales and marketing of those tests in India.

We have completed licensing of the plant in Rinoli, India, that will be used for testing and manufacturing for the Indian market.

the tests will be conducted in India on Indian citizens, no FDA approval or inspection will be required.

As mentioned above, the

CDSCO has given us the approval for manufacture and sale of the five tests referred above and the Company has begun to take orders

for our tests.

The Company has commenced a reagent rental program in India with our Mx Device.

We have placed five of our Mx Devices

with labs in India and have purchased an additional fifteen Mx Devices in the first quarter of 2020.

Each of the reagent rental

placements requires the purchase of a minimum of 250 tests per month.

We have submitted to the CDSCO our technical file requesting

approval for the manufacture and sale of our COVID-19 test in India and have received authorization to begin manufacture and sale

of COVID-19 tests on a RUO basis.

We intend to submit technical files to the CDSCO requesting approval tests for HIV and Dengue

as well as a blood bank panel before the end of the second quarter of 2020 and expect them to be approved for sale in 2020.

is the country with the highest burden of tuberculosis.

World Health Organization (WHO) tuberculosis statistics for India for

2015 give an estimated incidence figure of 2.2 million cases of tuberculosis for India out of a global incidence of 9.6 million.

The tuberculosis incidence for India is the number of new cases of active tuberculosis disease in India during a certain time

period (usually a year).

Sales of those tests have not been material, but

with the granting of a CE mark for our Logix Smart COVID-19, we began significant sales in this region.

Products are manufactured

for sale upon receipt of purchase orders from distributors, labs and hospitals.

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

manufacturing company in India and formed an Indian joint venture organized as CoSara Diagnostics, Pvt (“CoSara”).

The agreement provided for the construction of a manufacturing plant and the manufacture of the tests named above and the joint

sales and marketing of those tests in India.

We have received a license for the plant in Ranoli, India to manufacture approved

tests and has been used for testing and manufacturing for the Indian market.

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

has begun manufacture and sale of those tests.

The Company has commenced a reagent rental program in India with thermocyclers

purchased from third-party vendors and which we refer to as our MDx Device.

Each of the reagent rental placements requires the

purchase of a minimum number of tests per month.

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

COVID-19 tests in India, which has made CoSara profitable in 2020.

The World Health Organization (“WHO”) 2019 Global

Tuberculosis Report indicates that India is the country with the highest number of cases of tuberculosis in the world.

WHO tuberculosis statistics for India for 2018 give an estimated incidence figure of 2.69 million cases of tuberculosis for India

out of a global incidence of approximately 10.0 million.

The tuberculosis incidence for India is the number of new cases of active

tuberculosis disease in India during a certain time period (usually a year).

We believe that we will be able to sell our tuberculosis

test in India through our sales distribution network that we are building currently.

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

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

Because any commercial activity in India

was severely restricted until May 2020, CoSara was not able to commence the manufacturing and sale of the SaraGene COVID-19 tests

until late in the second quarter, but sales efforts have resulted in CoSara being profitable since the commencement of sales of

the COVID-19 tests.

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

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

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

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that the product is compliant with EU legislation and sold in the European Union.

We have received CE Marks for four of our tests

including COVID-19, tuberculosis, Zika, and our zika, dengue, chikungunya triplex tests.

We have received CE Marks for six of our tests

including COVID-19, COVID-19 (2 gene test), ABC (a triplex test for Flu A, Flu B and COVID-19), tuberculosis, Zika, and our Zika,

dengue, chikungunya triplex tests.

have received ISO 13485 and ISO 9001 certifications relating to the design and manufacture of our medical device products.

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for sales of our products in countries accepting the CE marking (not in the United States) with only minimal further governmental

approvals in each country.

Food and Drug Administration (FDA) has granted permission for us to export many of our products.

approvals and registrations in most countries.

Food and Drug Administration (FDA) has granted permission for us to export all of our IVD products.

The FDA’s permission

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Section 801(e)

applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing

We have applied to the FDA for Emergency Use Authorization for our COVID-19 test, which would allow sales in the US

to qualified labs.

do not anticipate offering our tests in the United States in the near future.

We believe, however, our tests may be able to qualify

as Laboratory Developed Tests (LDT’s), diagnostic tests that are developed and manufactured by CLIA certified laboratories.

These tests are developed by the lab for use only in that laboratory.

CLIA laboratories develop the performance characteristics,

perform the analytical validation for their LDT’s and obtain licenses to offer them as diagnostic services.

publicly announced its intention to regulate certain LDTs in a phased-in approach, but draft guidance that was published a couple

of years ago was withdrawn at the end of the Obama administration and replaced by an informal non-enforceable discussion paper

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

of the FDA Act applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s

Good Manufacturing Practices.

We have received EUA for our COVID-19 test, which allows sales to qualified labs in the United States.

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

labs are able to use our test as it is or further qualify our LogixSmart test as a Laboratory Developed Test (LDT), a diagnostic

test that has been validated for use in the CLIA lab.

These tests may be used by the lab only in that laboratory.

CLIA laboratories

develop the performance characteristics, perform the analytical validation for their LDT’s and obtain licenses to offer

them as diagnostic services.

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

draft guidance that was published a couple of years ago was withdrawn at the end of the Obama administration and replaced by an

informal non-enforceable discussion paper reflecting some of the feedback that it received on LDT regulation.

We are currently

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

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 active distributors, most of which have been the sales network that has allowed

us to export products throughout the world.

Approximately 40% of our sales in 2020 came through sales by our distribution

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

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

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

Using estimates of the incidence of disease by the Centers for Disease Control, the World Health Organization and other international

health agencies and sources, the Company estimates that the global annual demand for diagnostic tests are:

resistant Tuberculosis

Transmitted Illnesses

papilloma virus

1,993,680,000

are several advantages of molecular tests, such as the ones we market and sell, over other forms of diagnostic testing, which

include higher sensitivities, the ability to perform multiplex tests and the ability to test for drug resistance or individual

There are several advantages of molecular 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.

Vector Control Services

response to market demand, we introduced our first diagnostics tests to be used exclusively to test mosquito DNA in June 2019.

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

infect the human population.

To prevent outbreaks of potentially harmful viruses, such as Zika or West Nile, from infecting the

public the municipalities conduct spraying operations to eliminate the mosquito populations carrying the diseases.

is too expensive to spray all mosquito breeding areas, the problem is to identify which particular area has mosquitos that are

carrying the harmful viruses.

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

collected and then tested to find the areas that most needed spraying.

There are over three thousand mosquito abatement districts

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

first test is a triplex test that tests for West Nile, Western Equine and St.

Louis encephalitis.

We began shipping the tests

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

in June 2019.

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

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

and which infect the human population.

To prevent outbreaks of potentially harmful viruses, such as Zika or West Nile, from infecting

the public the municipalities conduct spraying operations to eliminate the mosquito populations carrying the diseases.

it is too expensive and potentially harmful to the environment to spray all mosquito breeding areas, the solution is to identify

which particular area has mosquitos that are carrying the harmful viruses.

To know where the host mosquitos with the harmful viruses

are located, traps are set, mosquitos collected and then tested to find the areas that most needed spraying.

There are over 3,000

mosquito abatement districts throughout the United States and almost all of them conduct testing to help make the spraying more

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

Louis encephalitis.

We began shipping

the tests in June 2019.

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

in November 2019, we completed a test for West Nile, eastern equine and St.

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United States.

As a result, mosquito abatement districts can test for three target viruses in one test for the same cost as one

test would cost ($10-$15) using other market available PCR tests.

Additionally, the districts are more effective because they

can get test results in a matter of hours using our product instead of weeks when they 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 seven different testing districts and are marketing our

products through trade shows, electronic and regular mail solicitations and have hired additional sales personal in the eastern

US to more economically and efficiently market to the east coast areas.

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

three different tests using other market available tests, which saves our customers money.

Additionally, the districts are more

effective because they can get test results in a matter of hours using our product instead of weeks when they 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 and have hired additional sales

personnel in the eastern US to more economically and efficiently market to the east coast areas.

Advantages of Co-Diagnostics

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CDI’s tests have been designed to run on many vendors’

DNA diagnostic testing machines.

These tests are

particularly well suited to the new generation of “lab-on-a-chip”

DNA/RNA diagnostic testing machines.

are particularly well suited to the new generation of “lab-on-a-chip”

and “point-of-care”

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

We believe our tests are more accurate than competitors’

We believe our tests are more sensitive and specific than competitors’

and can detect more strains of viruses.

Exclusivity :

CDI owns all patents and all intellectual property used in preparation of its tests.

We own all patents and all intellectual property used in preparation of our tests.

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

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A critical component will be

accurate, more affordable DNA-based diagnostics, which CDI plans to offer.

We plan to keep the Company’s overhead low.

Its platform technology obviates the need to pay patent

royalties typically required of its competitors, which use patented test platforms to design their tests.

With a dynamic technology that encompasses markets worldwide, the Company anticipates that it can identify

the best target markets, not only in high burden developing countries (HBDC’s) but also in developed nations.

accurate, more affordable DNA-based diagnostics, which we plan to offer.

We plan to keep our overhead low.

Our platform technology obviates the need to pay patent royalties typically

required of our competitors, which use patented test platforms to design their tests.

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

target markets, not only in high burden developing countries (HBDC’s) but also in developed nations.

Industry Category :

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Product Offering :

CDI’s ultra-sensitive tests can be a well-designed match for a new generation of handheld

and other small point-of-care devices now entering the market.

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

small point-of-care (POC) devices now entering the market.

Used together, these affordable tests and devices may revolutionize

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Multi-plexing:

Our initial development efforts have demonstrated that our Co-Primer designed tests will be able to test for multiple

targets in the same sample without the distortion caused by false negatives and false positives that generally occur in multiplexed

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

in the same sample without the distortion caused by false negatives and false positives that generally occur in multiplexed

Biopsy for Cancer Screening

development of the liquid biopsy test will spur low cost testing in many developing countries.

We believe that our liquid biopsy

cancer screening shall be ready for testing in 2020 if we have sufficient development resources to dedicate to the project.

applications of our SNP detection technology can determine the presence of cancer cells or cell-free genetic material in a liquid

or tissue biopsy, and to determine the distinct type of cancer involved.

A real-life example of this includes being able to identify

specific mutation(s) in genes linked to breast cancer in order to determine a patient’s prognosis, initiate the most effective

and affordable treatment and to determine whether chemotherapy is necessary.

After diagnosis the relative cost of our technology

allows for frequent testing to measure the effectiveness of the treatment.

development of liquid biopsy tests is expected to spur low-cost testing in many countries.

We believe that our liquid biopsy cancer

screening may be ready for testing in the foreseeable future.

Medical applications of our SNP detection technology can determine

the presence of cancer cells or cell-free genetic material in a liquid or tissue biopsy, and to determine the distinct type of

cancer involved.

A real-life example of this includes being able to identify specific mutation(s) in genes linked to breast cancer

in order to determine a patient’s prognosis, initiate the most effective and affordable treatment and to determine whether

chemotherapy is necessary.

After diagnosis the relative cost of our technology would allow for frequent testing to measure the

effectiveness of the treatment and thus could be a companion diagnostic for a range of treatments.

technology has for all practical purposes essentially eliminated, primer-dimers, which opens up some very unique applications

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

The results of the development project have been to successfully demonstrate our ability to not only multiplex the target genomes,

but targeted SNP’s as well.

The results of the development project have successfully demonstrated our ability to not only multiplex the target genomes, but

targeted SNP’s as well.

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

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industry, which was completed in October 2018.

Pursuant to the exclusive license for the agrigenomics industry, the licensee will

pay us a royalty for all CoPrimers sold to the licensee’s customers.

In January 2019, the licensee formally introduced the

product at a large agricultural conference and has branded the product to sell as BHQCoPrimers.

Pursuant to the exclusive license for the agronomics industry, the licensee pays

us a royalty for all CoPrimers sold to the licensee’s customers.

In January 2019, the licensee formally introduced the product

at a large agricultural conference and has branded the product under the name “BHQ CoPrimers”.

Licensing and Assay Development

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

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

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

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

their customers and potential customers, both in the infectious disease arena as well as for agricultural customers.

was amended in July 2019 and we will derive a license fee from our licensee for its design services.

If any of its customers desire

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

Because of these unique characteristics

of CoPrimers, research companies and institutions have requested that we design diagnostics to locate and identify uncommon gene

sequences and SNPs and create tests for the target sequences in a multiplexed reaction.

This application of our technology is

in its beginning stages, but we believe that the results from our initial research indicate a significant step forward in defining

the capabilities of our technology, which we believe can be translated to revenue producing licensing arrangements.

was amended in July 2019 and we expect to derive a license fee from our licensee for its design services.

If any of its customers

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

Because of these unique

characteristics of CoPrimers, research companies and institutions have requested that we design diagnostics to locate and identify

uncommon gene sequences and SNPs and create tests for the target sequences in a multiplexed reaction.

This application of our

technology is in its beginning stages, but we believe that the results from our initial research indicate a significant step forward

in defining the capabilities of our technology, which we believe can be translated to revenue producing licensing arrangements.

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

critical importance.

Five of our initial U.S.

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

Patent and Trademark

Office (PTO), including the patent for our CoPrimer technology, which we consider our most important patent.

One of our patents

has been issued in Great Britain, but is still pending in the United States.

As of March 2021, we had two additional patents pending

and foreign counterpart applications.

Two of our issued US patents expire in 2034, one in 2036 and one in 2038.

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

of the processes that are covered by the original patents.

We intend to continue building our intellectual property portfolio

as development continues and resources are available.

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

We have allowed

one potential customer access to our development software and intend to sell customized reagents through that customer to labs

serviced by that customer throughout the world.

To date we have not sold any products to that customer.

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

Two customers together accounted for approximately 38% of total revenue for the year ended December 31, 2020.

customers may not account for the same percentage of sales in future periods.

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

we were able to replace those customers with others.

molecular diagnostics industry is extremely competitive.

There are many firms that provide some or all of the products we provide

and provide many diagnostic tests that we have yet to develop.

Many of these competitors are larger than us and have significantly

greater financial resources.

Because we are not established, many of our competitors have a competitive advantage in the diagnostic

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

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

We will need to overcome the disadvantage of being

a start up with no history of success and no significant respect from the medical and testing professionals, although this is

changing as we continue to market our LogixSmart COVID-19 tests and other tests in the United States to well-known and successful

laboratories.

In the diagnostic testing industry, we compete with such companies as BioMerieux, Siemens, Qiagen, and Cepheid and

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

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

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

Numerous companies in the

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

used in substitution for our LogixSmart 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 both serological 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 price pressure on us to reduce

the price of tests to compete.

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 relationships with current and potential customers, including governmental authorities, and,

as a result, may be able to respond more quickly to new or changing regulatory requirements, new or emerging technologies, and

changes in customer requirements.

the United States, we are regulated by the FDA and our products must be approved by the FDA before we will be allowed to sell

our tests in the United States.

However, the FDA granted us an EUA to manufacture and sell our Logix Smart COVID-19 test to CLIA

labs in the United States.

Because our lab is ISO certified, we are allowed to apply for CE-Marking, which will allow us to sell

any CE Marked test in most countries in Europe, South America and Asia.

We currently have CE Marks 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

and a triplex test that distinguishes between Flu A, Flu B and Covid-19.

In addition, our Logix Smart COVID-19 has received the

license to manufacture and sell in India from India’s CDSCO and the National Epidemiology Institute in Mexico evaluated

our Logix Smart COVID-19 test and approved it for sale in Mexico.

We have also received approval to sell in Australia.

in the process of registering for sale our Logix Smart COVID-19 test in a number of major countries around the world.

of December 31, 2020, we had 37 full-time employees at our executive offices and lab facilities in Salt Lake City, Utah, and two

employees outside of 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”

Organizational

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Our telephone number is (801) 438-1036.

Our web address is http://codiagnostics.com.

Our web address is www.codiagnostics.com .

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

of Being an Emerging Growth Company

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

applicable to smaller reporting companies.

UNRESOLVED STAFF COMMENTS

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