20/20 GeneSystems has the option to secure exclusive U.S. marketing rights from large Chinese diagnostic companies that have each developed and validated rapid field tests for antibodies to Coronavirus 19. Unlike nucleic acid-based lab tests that require 2-3 day turnaround the field test now being marketed by 20/20 uses a fingerstick blood sample, requires no instrumentation and yields results in under 10 minutes. (The test configuration is similar to a home pregnancy test.)

On March 16th the FDA issued new regulatory guidance that makes it easier for companies like 20/20 GeneSystems in order to address “urgent public health concerns by helping to expand the number and variety of diagnostic tests”. See the FDA press release here.

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

Click here to view the full offering circular

We believe 20/20 is positioned to 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.

At 20/20, we have applied machine learning, powered by real-world data, into the fight against cancer.

• Since the “War on Cancer” was declared almost five decades ago by President Nixon, hundreds of billions of dollars have been spent on the development of treatments and cures.  But the survival rates for most late-stage cancers have changed little during this half-century. 

• However, early detection of many cancers through screening drastically improves survival. In lung cancer, the #1 cancer killer, the 5-year survival rate for screen-detected Stage 1 is better than 90% vs, less than 10% for Stage 4 when it is most commonly first diagnosed.

• For the past 40 years in the West, screening has been widespread only for cancers of the breast, colon, prostate, and cervix.   In the East, cancer screening is more widespread but the testing approaches have changed little over the decades, often missing early-stage cancers while generating large numbers of false positives.

• 20/20 is working to “bend the curve” of cancer mortality around the world through AI-enhanced early detection.

• 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

• Our company has pioneered a machine learning method to significantly improve the testing approaches commonly used in the East to screen tens of millions each year.  See www.OneTest.AI 

• 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

We believe that 20/20 is one of the first, if not the first, company to adopt this approach and is actively building patent and other barriers to market entry by emerging competitors 

Unfortunately, studies show in the United States that 1 in 2 women and 1 in 3 men will develop some form of cancer in their lifetime (source). The future is looking bleaker as well, with the number of new cases of cancer set to nearly double by the year 2050. The time to act is NOW. 

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. 

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.  

Fire Departments--an important market segment due to high cancer incidence and death rates--in the following states have ordered OneTest as of December 2019:

• Maryland

• Virginia

• Louisiana 

• Texas

• Indiana

As of December 2019, OneTest Software Subscription Agreements (permitting local access to our algorithm over the cloud) or Regional Marketing Representation Agreement is in place in the following countries.

China’s Ping An, likely the world’s largest Healthcare AI company with nearly 300 million users of its Good Doctor mobile diagnostic app, is a large investor and Board member in 20/20  and has begun in late 2019 to help implement our China strategy.

In February, we closed over $5 million Reg. A+ round in February 2019 making 20/20 one of the most successful U.S. life science companies at equity crowdfunding:

Our product, OneTest™, is a multi-cancer blood test aimed at aiding in the early detection of cancer through tumor marker testing powered by machine learning algorithms built with data from tens of thousands of individuals tested before being diagnosed with cancer.

A blood specimen is analyzed utilizing a panel of five or six tumor biomarkers (depending on gender) which may be elevated when cancer is present, even in early stages of development.  To calculate an individual’s cancer risk “OneTest Score”, we employ machine-learning algorithms that incorporate the results of these blood tests along with individual information, such as age and gender, which can further improve test accuracy compared to testing tumor biomarkers individually.

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

• 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 (Software-as-a-Service or SaaS) basis.

• 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

• The data used to build the 20/20 algorithms has been collected over several years and we continually acquire new data from product use worldwide.  This further improves our algorithms and we believe distances us from would-be competitors.

The overwhelming majority of our current and emerging competitors developing or commercializing blood tests for the early detection of multiple cancer (a/k/a “pan-cancer tests”) utilize novel biomarkers or testing technologies (e.g. next-gen sequencing of circulating tumor DNA).  Validating such tests in a real-world screening population (i.e. asymptomatic individuals) is extremely expensive and time-consuming.  However, by utilizing biomarkers already used widely around the world for screening, our company can meet these validation requirements with much less cost and burden.  

2019 was the first year we commercialized our test.  Our goal is to rapidly grow our sales  over the next four years.  We expect that more than 80% of these tests would be run by outside clinical laboratories where 20/20’s revenues would be limited to remote algorithm access.   Less than 20% of these tests would be assumed to include blood specimen analysis by 20/20’s clinical laboratory in the United States (“full service testing”).  

(We cannot now assume whether the current revenue levels for full-service testing or algorithm access can be sustained to meet the aforementioned goals.  Please read and consider Forward-Looking Statements for additional qualifications and risk factors.)

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.

John Compton, Ph.D.  Board Chair

• Served as Scientific Director and Co-President of GeneDx Inc

  • operating assets of which were acquired by BioReference Laboratories (now part of Opko) in September 2006. 

  • GeneDx is a world leader in genomics with an expertise in rare and ultra-rare genetic disorders as well as one of the broadest menus of sequencing services available among commercial laboratories. 

    • Provides testing to patients and their families in more than 55 countries. See http://www.genedx.com 

• 25 years experience in the development and application of molecular biological techniques to answer questions about genetics and epidermal differentiation and has authored more than 60 publications in the field.

• B.S. degrees in Physics and Biology from MIT

• Ph.D. from the University of California, Berkeley in Biophysics

• Post-doctoral training in protein-DNA interactions at the Baylor College of Medicine. 

Ted Driscoll, Ph.D. Director

• Harvard, Stanford

• Started five companies that pioneered digital imaging. (Patents include iPhone digital fingerprint recognition, first MRI scanner, 360-degree imaging that became Google Street View)

• Former VC with Claremont Creek

• Pioneer in promoting CLIA Lab approach as FDA alternative

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).  

Who should be tested? 

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.

Has your test been approved by the FDA? 

OneTest is classified as a Laboratory Developed Test (LDT) since the test is run in the lab of the test developer. Except in very rare circumstances, LDTs are not currently regulated by the U.S. Food & Drug Administration (FDA) but are instead regulated by the Center for Medicare & Medicaid Services (CMS) and the state health departments under the Clinical Laboratory Improvement Amendments (CLIA). 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.

The instruments that we use in our CLIA lab are approved by the FDA, and the reagent kits that we use are also approved for various uses. 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.

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.

Does insurance cover it?

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.

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.

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