Offering Circular | Selected Risks Related to this Offering
20/20 GeneSystems' SEC EDGAR Page | "Signed to Trade" disclosure

For more information on 20/20 GeneSystems Inc. download and review the Offering Circular. The Offering Circular should be reviewed before making an investment decision

20/20 GeneSystems has also raised $2,238,112.80 towards the offering maximum for this offering outside the platform through another broker-dealer.

• Huge Market - The global cancer diagnostics market was valued at $7.1 billion in 2015 and is projected to reach $13.1 billion by the year 2020
• Experienced Team - Our CEO previously established strategic partnerships with Fortune 500 companies such as Johnson & Johnson, Eastman Kodak, Abbott Diagnostics and Smiths Detection
• Traction - We're backed by China’s Ping An Ventures, likely the world’s largest Healthcare AI company (300 million users of its mobile diagnostic app) & thousands of investors

20/20 is pioneering a brand new approach to improve the accuracy and usefulness of conventional clinical lab testing. Rather than simply reporting the biomarker levels, in the way they have for decades, we leverage vast amounts of real-world data together with machine learning to compare the individual’s test results to those of tens of thousands of others with known health outcomes. This proprietary technique is already being used to improve early cancer detection and will soon be deployed to monitor the immunity protection after vaccination.  Plans are in the works to expand to heart disease and other chronic conditions. 

For more information about the rapid test, visit our website at www.CoronaCheckTest.com.

Cancer is the 2nd leading cause of death in most of the industrialized world with survival rates closely tied to stage at time of diagnosis. For example, the 5-year survival rate for lung cancer falls 90% when it passes from Stage 1 to Stage 4.

We believe 20/20 is positioned to help transform the way cancer is screened worldwide, and in doing so, help score a major victory in the fight against this dreaded disease. Despite advancements in treatment, once cancer has gone undetected through its early stages, it frequently becomes lethal. Therefore, the key to winning the fight against cancer is transforming the way cancer is screened for and detected.    

OneTest™ aids in the early detection of multiple cancers from one blood sample. See www.OneTest.AI. In the U.S., the product includes a laboratory developed blood test comprising 6 biomarkers and a machine learning algorithm. Customers have their blood draws sent to our CLIA lab where we perform our analysis and then report the results. Overseas we provide the algorithm only as the biomarker testing can be conducted at thousands of laboratories around the world. This approach is capital efficient and protects our IP.

Testing of tumor markers is performed at the 20/20 GeneSystems’ CLIA laboratory using the Roche Cobas e411 platform. FDA approved Roche IVD reagent kits are used according to manufacturer specifications. Results of individual tumor marker tests are used to calculate a risk score using a proprietary machine-learning algorithm and then generate a patient report. The OneTest report provides the following information to the patient:

1. The individual biomarker levels  
2. An overall cancer risk OneTest Score calculated using a machine learning algorithm

Key features of the current product are as follows:

• A cloud accessible tool to improve the accuracy of tumor marker blood tests (CEA, AFP, CA-19.9, etc.)

• Useful in early detection of multiple types of cancer (lung, liver, pancreas, etc.)

• Incorporates clinical factors (age, gender, smoking history, etc.)

• Stores & displays each individual’s biomarker trends from successive tests

• Uses machine learning / AI

The technical underpinnings of OneTest™ are described in a high impact, reputable peer-reviewed journal article: Wang, et al. “Improving Multi-Tumor Biomarker Health Check-Up Tests with Machine Learning Algorithms”. Cancers 2020, 12, 1442 that was published June 1, 2020.  

To the best of our knowledge, 20/20 is the first company to commercialize multi-cancer screening blood tests powered by AI and machine learning algorithms built with real-world outcome data from tens of thousands of previously tested individuals. Screening tests and algorithms must be validated in a “pre-diagnostic” population (i.e. individuals tested before being diagnosed with cancer) to be proven reliable. Our approach of “harvesting” real-world data permits rapid validation from this population with limited costs.

These proprietary algorithms combine the levels of multiple tumor biomarkers (such as CEA, AFP, CA-125, etc.) with clinical factors (e.g. age, gender, smoking history, etc.) and automatically finds “look-alikes” between the tested individuals and tens of thousands of individuals previously tested with the same biomarkers for whom cancer incidences are known.

Biomarker trends from repeat tests are collected, displayed, and stored on our portal since rising biomarker levels often signal an early-stage disease.

In the U.S. we sell OneTest (www.OneTest.AI) to both individuals and occupational groups (e.g. Fire Departments) with proven high cancer risk. Overseas we make the OneTest algorithm available on the cloud to health examination centers on a subscription basis.

We believe that ultimately everyone, everywhere, should take OneTest every year. Recent studies by leading cancer geneticists at Johns Hopkins suggest that far more cancers are caused by aging than from family history, the environment, or lifestyle. This suggests that all adults, beginning in middle age, should be screened regularly for a wide array of cancers. In fact, throughout East Asia most adults receive tumor antigens testing each year at “Health Check Centers.” 

Thus the market for multi-cancer screening blood tests includes all adults worldwide roughly between the ages of 45 and 75 (the optimum ages for cancer screening). Currently, there are no widely used safe and affordable tests that help identify as many cancers as our OneTest at comparable price and accuracy levels.

While we see OneTest being a universal test in the long-term in the near-term we are focusing on occupations with proven high incidents of lethal cancers. Studies by the U.S. National Institute of Occupational Safety & Health (NIOSH) demonstrate that firefighters are one such occupation. Thus, America’s more than one million career and volunteer firefighters are a key market for OneTest. See www.OneTestforCancer.com/firefighters.

To date OneTest has been ordered for over 3,500 firefighters including orders from over 30 separate fire departments in 16 states.  In January the Fairfax County, VA recently ordered the test for nearly 1,500 of their members using a grant from the Federal Emergency Management Agency.  

About one month into the start of the pandemic we began to source and procure rapid tests backed by strong scientific evidence.  Currently 20/20’s COVID-19 tests include a viral (PCR) test whose customers are nursing homes and County and State governments, rapid antibody tests with pharmacies as customers, antigen tests with customers being a service provider to and operators of clinics, and a Roche quantitative test with independent pharmacies and urgent care facilities as customers.

COVID Antibody Tests

Rapid Antibody Tests - Early in the pandemic we leveraged our relationships in China to procure and validate rapid COVID-19 antibody tests that can be used at clinics and pharmacies. To date we have sold COVID-19 antibody tests generating over $1.2 million in revenues. Our approach in COVID-19 testing has been to affiliate with the best products available (versus developing and manufacturing our own) so as to accelerate our time to a market in a highly fluid environment. This approach also preserves capital while minimizing the risk of being stuck with a technology from which the market moves away.  

Independent pharmacies have been among our most active customers of rapid antibody tests. We believe that this large market segment (there are over 20,000 independent pharmacies in the U.S.) is ripe for growth with additional testing products after the pandemic.

Quantitative Antibody Testing - We also offer one of the first quantitative tests for COVID-19 antibodies that can accomodate capillary blood from a fingerstick, in lieu of venous blood drawn by a phlebotomist. This arrangement permits fingerstick blood specimens to be collected at a pharmacy and sent to 20/20’s CLIA lab for quantitative analysis.

The quantitative test,  purchased by us from Roche Diagnostics, is expected to be useful following vaccination to assess the durability of immunity. Before a vaccine is administered it is important to know the starting level of antibodies a person has, in order to evaluate any change in antibody levels that the vaccine induces, especially the development of antibodies directed against the SARS-CoV-2 spike protein. These antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Monitoring antibody levels over time may become vital in assessing the durability of immunity in the months after vaccination.  

We are in the process of organizing studies with local and international partners to help ascertain the precise antibody levels below which protective immunity begins to wane. Our goal is to develop a machine learning algorithm for Covid immunity monitoring similar to the approach we used for early cancer detection.

Viral (PCR) Testing

In September 20/20 introduced molecular (PCR) testing in our CLIA lab which previously ran only immunoassays for tumor markers.  We began running COVID-19 nasal swab specimens from three Maryland nursing homes. This testing activity is expected to grow at least through the second Quarter of 2021.    

Long-term Value from COVID Testing Experience

In addition to revenue generation, we believe the profits from which will be re-invested in longer term growth opportunities, pandemic testing will create shareholder value after the emergency in at least the following ways:

• New testing equipment, acquired for Covid-testing can be used in other disease areas. More specifically our CLIA lab, is for the first time able to conduct DNA analysis rather than just proteins and  immunoassays.

• New market segments and verticals have been established.  In particular we are now selling tests to over 35 independent pharmacies.   We believe that pharmacies could become an accessible venue for our OneTest and future diagnostics in other disease areas.  

• New test developers have been identified and are currently supplying us with tests for sale in the U.S.  These test developers and manufacturers will likely expand their test menus after “herd immunity” is reached.  20/20 plans to seek co-development and exclusive marketing relationships with some of these developers. 

20/20’s Growth Trajectory - Between 2019 and 2020 our company’s year-over-year revenues grew by 700% largely as a result of pandemic related testing.  According to the Inc. 5000 annual list such growth would put us among the 1000 fastest growing companies in America.

Key goals and priorities to help yield sustained commercial traction and revenue growth in the 24 month period following the pandemic emergency include the following:

• Significantly Grow OneTest for Cancer in the USA. Improvements that would permit faster scale of this product include the use of capillary blood collected via fingerstick versus venous blood collected by a dedicated phlebotomist.   This approach, following significant equivalency studies, would permit OneTest to be offered in pharmacies which do not typically employ phlebotomists.  

• Develop OneTest for Heart Health. We are in discussions with a leading research institution about a panel of blood based cardiac markers that can be combined with blood pressure and EKG that use machine learning algorithms that can help predict the likelihood of cardiac arrest and stroke.

• Launch OneTest Algorithm Portal in China and Russia. 20/20 is actively planning new initiatives in both China and Russia for the commercialization of the OneTest portal and algorithm due to the common testing of tumor markers in healthy populations in both of those countries.

20/20 consists of a very enthusiastic and driven team dedicated to our core mission of reducing cancer mortality in the U.S. and around the world through early detection.  We are focused on trying to save as many lives as possible while also creating a successful and sustainable business.  As you can see in the “Bios” section, 20/20 has assembled a very diverse and experienced team with expertise across various aspects of science and business.

Thanks to recent legislative changes you can now own shares of a company we believe is uniquely positioned for growth and with the ability to save many thousands of lives around the world (perhaps yours or a loved one).  

Does OneTest require FDA pre-market approval?

No.  As a “laboratory developed test” (LDT) run out of the clinical laboratory that developed it, OneTest is regulated under the Clinical Laboratory Improvement Act (CLIA) by the Center for Medicare & Medicaid Services (CMS) and the Maryland Department of Health.  FDA, with rare exceptions, does not participate in the regulation of  LDTs.  In general, CLIA approval is directed at laboratory procedures and the technical performance and analytical validity of the test (i.e. whether the test delivers consistent results) rather than the impact of the test on disease outcomes.  However the instrumentation and detection kits used in our CLIA lab are FDA cleared.  For example, PSA is approved for screening for prostate cancers. The other biomarker detection kits that we use are approved for assisting in diagnosing cancer, monitoring cancer recurrence, and / or therapeutic monitoring. However, several foreign counterparts to the FDA have approved the biomarker test kits we use for use in screening and early detection resulting in the same tests we are using being employed in those countries for the yearly screening of tens of millions of individuals.

What makes OneTest better than its competitors?

While there are very few multi-cancer screening blood tests on the market, there are many emerging competitors, most utilizing sequencing of circulating tumor  DNA.  Some of OneTest’s key advantages over these competitors are: use of proven biomarkers, vast sets of real-world data,  and affordability.  OneTest’s underlying panel consists of well known markers used to test tens of millions of individuals each year, primarily in East Asia.   Enhancing the power of these markers is our unique access to the real data of over 200,000 real world patients which allows the AI algorithms to extrapolate one’s cancer risk to a higher degree of accuracy.  The DNA sequencing tests are expected to price at around $600 to $1000 versus $189 for OneTest, an important differentiator since all of these tests will be self-pay for the foreseeable future.

Who should be tested with your multi-cancer blood test? 

Most people incorrectly assume that family history, lifestyle, and environmental exposures are the leading causes of cancer. However, a 2017 study by leading cancer geneticists from Johns Hopkins found that among all tumor types, 66% of the genetic mutations that lead to cancer come from random mutations over a lifetime, 29% from lifestyle or environment, and only 5% from genes inherited from parents. Thus, even those who have little or no family history of cancer and who lead a healthy lifestyle would be wise to routinely screen for cancer. This is the standard practice in Japan, Korea, China and throughout the Far East where nearly all adults, starting at about age 40, undertake day-long annual health checks that usually include blood tests of many of the same protein biomarkers that are part of OneTest.

How accurate is your test?

For detailed information on the accuracy of OneTest, please visit our website https://onetestforcancer.com/learn/. Then, click the “Accuracy, Reliability & Scientific Support” tab.

Are your tests covered by health insurance?

The COVID-19 tests we offer are reimbursed by insurance.  But not our cancer tests.  With rare exceptions, health insurance (including Medicare) primarily covers treatments and tests for those that have, or are suspected to have an illness or injury. Very few preventative services and screenings for persons without disease symptoms are covered and the exceptions follow ironclad proof that the benefits of the product outweigh the costs of screening hundreds of thousands of individuals over many years. Thus, even in East Asia and Europe, where blood tests for cancer screenings are far more common than in the U.S., screening tests are usually paid for by employers and the individual consumer, not insurance plans. While we do not expect the major insurance plans to cover OneTest any time soon, most HSA / Flex spending accounts can be used for payment.

ABOUT CORONAVIRUS TESTS

What is the value of Covid-19 antibody tests?

Many experts believe that antibody tests, especially those that quantify the levels of antibodies, will be critical in monitoring the strength and durability of immunity in the months following vaccination.   While the precise antibody levels needed for protective immunity are not yet clear, many groups, including 20/20, are committed to conducting research to help identify those numbers.  

How might the company replace these revenues after everyone is vaccinated?

We expect to sell additional products (e.g. OneTest) to some of our newer customers such as pharmacies.   Additionally royalties for licensing our algorithms overseas, especially in Russia, may compensate for some of the revenues we are now deriving from pandemic related diagnostics.  

Due to circumstances related to COVID-19, 20/20 GeneSystems, Inc. is not able to meet the filing deadline required by Regulation A for its Annual Report on Form 1-K for the year ended December 31, 2019. The Company is relying on the temporary final rules adopted by the Securities and Exchange Commission, which provides a 45-day extension to file the Form 1-K, and intends to file its Form 1-K on or before June 15, 2020.

AN OFFERING STATEMENT REGARDING THIS OFFERING HAS BEEN FILED WITH THE SEC. THE SEC HAS QUALIFIED THAT OFFERING STATEMENT, WHICH ONLY MEANS THAT THE COMPANY MAY MAKE SALES OF THE SECURITIES DESCRIBED BY THE OFFERING STATEMENT. IT DOES NOT MEAN THAT THE SEC HAS APPROVED, PASSED UPON THE MERITS OR PASSED UPON THE ACCURACY OR COMPLETENESS OF THE INFORMATION IN THE OFFERING STATEMENT.

THE OFFERING CIRCULAR THAT IS PART OF THAT OFFERING STATEMENT CAN BE FOUND HERE.

THE OFFERING MATERIALS MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY.  THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT.  WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD-LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS.  INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE.  THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.

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