The 20/20 GeneSystems, Inc. offering is now closed and is no longer accepting investments.

20/20 GeneSystems, Inc.

Diagnostic Testing for COVID-19 & Cancer

20/20 GeneSystems, Inc.

Diagnostic Testing for COVID-19 & Cancer

Wilmington, DE
Health Tech
20/20 GeneSystems (“20/20”) is a digital diagnostics company with a core mission of reducing cancer mortality in the U.S. and around the world through early detection. In response to the global pandemic we expanded our test menu to include an array of Covid-19 testing solutions. Year-over-year revenues have increased by 700%.

$2,871,738

raised
$6,261,634
previously crowdfunded
2,792
Investors
$38.5M
Valuation
$4.40
Price per Share
$501.60
Min. Investment
Preferred
Shares Offered
Equity
Offering Type
$14.7M
Offering Max
0
Days Left

$2,871,738

raised
$6,261,634
previously crowdfunded
2,792
Investors
$38.5M
Valuation
$4.40
Price per Share
$501.60
Min. Investment
Preferred
Shares Offered
Equity
Offering Type
$14.7M
Offering Max
0
Days Left
offering closed
This offering ended on June 16, 2021 and is no longer accepting investments.

Offering Circular |Supplement 1 |Supplement 2 |Supplement 3 | 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.


Reasons to invest



  • 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


Contributing to the Fight Against Cancer & COVID-19 with “Digital Diagnostics”


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.



Our story


Early Detection of Cancer

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.    


the solution


20/20’s OneTest: A machine learning enhanced blood test to help detect multiple cancers early


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


OneTest International Market Process



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.

Market


Who should get OneTest? 

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.  





Covid-19 Testing

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.

growth


New Customers, Collaborators, Technologies, and Other Resources acquired during the pandemic will help propel our growth in 2021 and beyond!

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.


leadership



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.





why invest


Invest in saving lives

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).  


faqs


ABOUT OUR CANCER TESTS


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.


WHILE THE COMPANY HAS SIGNED A QUOTATION AGREEMENT TO TRADE THE SECURITIES OFFERED ON STARTENGINE SECONDARY’S NEW ALTERNATIVE TRADING SYSTEM (THE “ATS”), A COMPANY WHICH INTENDS TO BE QUOTED ON THE MARKETPLACE WILL BE SUBJECT TO CERTAIN REQUIREMENTS WHICH THE COMPANY MAY OR MAY NOT BE ABLE TO SATISFY IN A TIMELY MANNER. EVEN IF A COMPANY IS QUALIFIED TO QUOTE ITS SECURITIES ON THE MARKET, THERE IS NO GUARANTEE AN ACTIVE TRADING MARKET FOR THE SECURITIES WILL EVER DEVELOP, OR IF DEVELOPED, BE MAINTAINED.  YOU SHOULD ASSUME THAT YOU MAY NOT BE ABLE TO LIQUIDATE YOUR INVESTMENT FOR SOME TIME OR BE ABLE TO PLEDGE THESE SHARES AS COLLATERAL.


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Updates

FINAL HOURS LEFT!

6 months ago

This is a final warning to all potential investors to not get left behind on this offering!  This has been an incredible journey and we know our investors are some of the best out there.  We cannot wait for what the future holds for 20/20 GeneSystems and we are excited with our current path forward!  We thank you for your support and for the thousands of followers that haven't yet invested, yes, the train is leaving the station. Don't get left behind!

Last Day To Invest In This Offering!

6 months ago

Welcome to the last day!  As we look towards closing this round, we need your help to get more funding.  We have seen the power of crowdfunding first-hand as a powerful way to shape the future we live in.  If you haven’t invested in 20/20 GeneSystems yet, we urge you to join us on this journey with us! Please share this opportunity to invest in the forefront of cancer diagnostics with your friends and family!  

3 Days Left: The Final Countdown!

6 months ago

Only 3 days left! Did you know that 20/20 GeneSystems has over 5K followers on StartEngine?!  We know you’re watching diligently as our raise continues to grow.  This is your opportunity to become a part-owner of a company that is truly making a difference in the world around us everyday.  This is your chance to make a difference by investing in 20/20 GeneSystems today - Don’t miss out!

Treating Early Stage Lung Cancer - 4 Days Left

6 months ago

The most exciting trend in cancer treatments is undoubtedly immunotherapy, the approach of stimulating the body’s immune system to fight tumors.   For the most part these treatments have been reserved for late stage cancers when survival odds tend to be bleak.   However, last month there was a report of the first immunotherapy drug to significantly reduce the risk of cancer recurrence or death in people with early-stage lung cancer.Atezolizumab reduced by 34% the risk of disease recurrence or death in a certain group of people with stage II to IIIA non-small cell lung cancer.  Lung cancer is the leading cancer killer in the United States, accounting for a quarter of all cancer deaths, the American Lung Association says. Non-small cell lung cancer makes up 4 out of 5 lung cancer cases.

 

Experts suggest that this development will increase demand for tests that can aid in the early detection of lung cancer since the drug represents an opportunity to save the lives of lung cancer patients, if their malignancies are caught in time.

"It is important to emphasize that patients need screening to detect lung cancer early, when it is potentially curable," said Dr. Heather Wakelee, chief of oncology at the Stanford University Medical Center.

 

Fortunately, early detection of lung cancer has been a longstanding focus of 20/20 GeneSystems.   Our first cancer test called “PAULAs test” was focused on non-small cell lung cancer and this test measured many of the same biomarkers in OneTest.   We are now transitioning the lung cancer algorithm developed with PAULAs test into OneTest.


StartEngine Secondary Details - 5 Days Left!!

6 months ago

We’re approaching the final days of being able to invest in this round of fundraising! We intend to quote on StartEngine Secondary - So we figured this would be a perfect time to give some more details on how it works!
StartEngine Secondary is intended to be one of the first public trading marketplaces in the US for companies that have raised capital via Regulation A+ and Regulation Crowdfunding.  Today if you invest in a company on StartEngine, you typically can’t exit your investment until that company experiences a liquidity event, such as being acquired by another business or an IPO.  Those events can take anywhere from 5-10 years to occur, if they occur at all.  
StartEngine hopes to change that with StartEngine Secondary.  The long term plan for StartEngine Secondary is for investors to trade their startup investments on their public marketplace if available.  The main intention is to bring potential liquidity to the private investment marketplace.  
We here at 20/20 GeneSystems are very excited about potentially being one of the first companies to quote on StartEngine Secondary and we cannot wait to see what the next steps are for this new age in finance that is constantly evolving in front of our eyes!
Don’t wait to invest in 20/20 GeneSystems today!

While the company has signed a quotation agreement to trade the securities offered on StartEngine Secondary’s new alternative trading system (the “ATS”), a company which intends to be quoted on the marketplace will be subject to certain requirements which the company may or may not be able to satisfy in a timely manner. Even if a company is qualified to quote its securities on the market, there is no guarantee an active trading market for the securities will ever develop, or if developed, be maintained. You should assume that you may not be able to liquidate your investment for some time or be able to pledge these shares as collateral.

Treating Early Stage Lung Cancer - 6 Days Left

6 months ago


The most exciting trend in cancer treatments is undoubtedly immunotherapy, the approach of stimulating the body’s immune system to fight tumors.   For the most part these treatments have been reserved for late stage cancers when survival odds tend to be bleak.   However, last month there was a report of the first immunotherapy drug to significantly reduce the risk of cancer recurrence or death in people with early-stage lung cancer. Atezolizumab reduced by 34% the risk of disease recurrence or death in a certain group of people with stage II to IIIA non-small cell lung cancer.  Lung cancer is the leading cancer killer in the United States, accounting for a quarter of all cancer deaths, the American Lung Association says. Non-small cell lung cancer makes up 4 out of 5 lung cancer cases.

Experts suggest that this development will increase demand for tests that can aid in the early detection of lung cancer since the drug represents an opportunity to save the lives of lung cancer patients, if their malignancies are caught in time.

"It is important to emphasize that patients need screening to detect lung cancer early, when it is potentially curable," said Dr. Heather Wakelee, chief of oncology at the Stanford University Medical Center.

Fortunately, early detection of lung cancer has been a longstanding focus of 20/20 GeneSystems.   Our first cancer test called “PAULAs test” was focused on non-small cell lung cancer and this test measured many of the same biomarkers in OneTest.   We are now transitioning the lung cancer algorithm developed with PAULAs test into OneTest. 

Final 7 Days For This Round Of Fundraising Left!

6 months ago

As we approach our final week of fundraising, we must say, this raise has been an amazing testament to what we do here at 20/20 GeneSystems.  We’d like to take this opportunity to thank the people behind the scenes who consistently push us to make the world a better place.  Our team works tirelessly to work through these important issues - they deserve our recognition and support.  If this sounds like a company you can see yourself identifying with, please invest now as this offer will not last much longer!

OneTest for Cardio Planned

6 months ago

Over the past few weeks 20/20 has taken preliminary steps towards applying our pioneering testing methodology to diseases beyond cancer.  


The unique approach of OneTest for Cancer (which we call “20/20 Hindsight”) is to harvest large quantities of real-world outcome data from previously tested individuals and use it to build machine learning algorithms that help predict likelihood of disease.   Our next target is cardiovascular disease which remains the #1 killer in most of the world.  


Last month we retained two medical specialists as consultants to help us identify data sources that may permit us to build “OneTest for Cardio.”   Neil Kramer, M.D. has practiced cardiology for over four decades  and Michael Rose, M.D. practices internal medicine at Johns Hopkins medical system.  

Most Supplemental Insurance Plans Pay for OneTest

6 months ago


Over 40% of large employers in the U.S., public and private sector, offer supplemental insurance (a/k/a "voluntary benefits") to their employees. Many of these plans, from carriers such as Aflac, MetLife, and others, include a wellness or screening benefit that pays policy holders at least $50 once per year for designated screening tests. The biomarkers measured with OneTest (PSA, CEA, etc.) qualify for a screening benefit with most of these plans. An example of one such benefit list may be viewed here.

 

A leading national voluntary benefits carrier is now conducting a pilot in a Maryland county to assess the value of offering OneTest to its beneficiaries and customer leads.  We are hoping the assessments leads to a relationship with the carrier, which could potentially expand exposure to our products and cover the bulk of future customers testing costs.  




20/20’s Shares are Expected to Quote on StartEngine Secondary

6 months ago

Since the implementation of the JOBS Act of 2012 Americans at nearly all economic levels have been free to buy stock in companies before they go public.  This was a revolutionary change in that since the 1930’s only wealthy individuals were free to invest in these companies (with some limited exceptions.)   However for equity crowdfunding to be sustainable it is important to expand opportunities not only to buying stock but for selling as well.

We are therefore pleased to announce our intention to become one of the first crowdfunded companies to quote our shares on StartEngine Secondary, a new “alternative trading system” or “ATS” established specifically for companies like 20/20 that have succeeded under Regulation A+.  Our hope is to provide liquidity to our shareholders through this new endeavor for 20/20 GeneSystems.

While the company has signed a quotation agreement to trade the securities offered on StartEngine Secondary’s new alternative trading system (the “ATS”), a company which intends to be quoted on the marketplace will be subject to certain requirements which the company may or may not be able to satisfy in a timely manner. Even if a company is qualified to quote its securities on the market, there is no guarantee an active trading market for the securities will ever develop, or if developed, be maintained. You should assume that you may not be able to liquidate your investment for some time or be able to pledge these shares as collateral.

15 Days Left! Don’t Get Left Behind!

6 months ago

We have officially chosen a closing date for our raise here on StartEngine.  This means you only have 15 days left to become an investor in this round of fundraising! We thank you for being part of our journey in the fight against cancer. We couldn’t have done it without such amazing investors by our side along the way.  Please continue to invest and share with your friends and family about this exciting opportunity!  We can’t thank you enough for all the support!


Meet Dr. Michael Lebowitz - 20/20’s Chief Scientific Officer

6 months ago

20/20 seeks to "do well and do good" by working to not only grow revenues (and our valuation) but to advance lifesaving research and development. Heading up our team of four Ph.D. scientists is Dr. Michael Lebowitz. PhD. our Chief Scientific Officer.

Dr. Lebowitz has more than 30 years of experience in biomedical research including 22+ years in the biotech industry and more than 18 years in research management. He has experience in both diagnostic and therapeutic development including discovery and development of novel biomarkers, antibody-based drugs, vaccines and cell therapies. He has worked in multiple disease areas including cancer, infectious disease, neurodegenerative disease, immunology and vaccine technology. 

Michael is also an adjunct faculty member at Johns Hopkins University.

While Director of Research at 20/20 GeneSystems from 2009-2012 he spearheaded the development and launch of our PAULA’s test for the early detection of lung cancer which evolved into our multi-cancer screening blood test called OneTest. 

Large Influx of Leads for OneTest

7 months ago

20/20 GeneSystems has been having much success of late with our lead generation marketing campaigns through LinkedIn and Facebook for OneTest.  These leads are a valuable way to increase our amount of OneTest distribution across the United States with a current focus on the fire department sector.  This is part of our transition from Covid testing to more long-term growth opportunities. Routine testing and screenings for chronic diseases and cancers seems to be rebounding after being curtained during the pandemic.  

Firefighters are a good initial market as they are actively seeking new cancer screening approaches since they have proven deaths rates for many different tumor types.  From there we will segue to occupational health and corporate wellness.  


We encourage you to invest here if you have not done so already. Thank you for your continued support!

Hear from Customers Using OneTest for the Early Detection of Cancers

7 months ago

Growing numbers of Fire Departments across the country are using OneTest since this profession sees higher than average numbers of cancers. Here is how a few of our over 30 Fire Department customers feel about why 20/20’s unique test has become part  of their cancer screening and prevention programs:


“As Chief, this was the easiest decision ever. We just bought these for our department. All 411 members have the option to participate if they would like. If your people are your greatest asset, why would you not protect it?” - Chief Landry Merkison, Clayton County, GA Fire & Emergency Services


“I just did my test today. It was easy. Just went to my doctor with the kit I got from OneTest. My doctor did some research on the test before I got there and she told me it was a great test for the money.” -Captain Justin Ulrich  California Pines Fire Department


“Adding the OneTest into our annual physical assessments has helped to provide not only early warning for some of the common types of cancer plaguing our industry but also a sense of relief and security.” - Mansfield Fire Department Texas


This testimonial may not be representative of the experience of other customers and is no guarantee of future performance or success.

Why American Firefighters Continue to Embrace OneTest

7 months ago

Studies by the National Institute of Occupational Safety & Health and others conclude that firefighters have a greater number of cancer diagnoses and cancer-related deaths than the general U.S. population. This includes cancers of the lung, prostate and colon, respiratory and digestive tract.


OneTest, as part of an annual check-up, is intended to aid in the detection of multiple cancers at earlier, more treatable stages.   It uses advanced artificial intelligence algorithms aided by real-word data to improve the value of existing and well known tumor markers used by millions around the world every year.  Annual testing can detect subtle changes in cancer marker scores that may successfully lead to early diagnoses of developing cancers.


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.  


We believe these early signs of success within the firefighter cancer screening market show great future potential if these trends hold steady.  We encourage you to invest here if you have not done so already. Thank you for your continued support!

“20/20 Hindsight”--Our unique technical approach

7 months ago

Our company has pioneered a novel and proprietary approach to improving the performance of otherwise routine clinical lab tests.  In short we collect data from large numbers of individuals who were tested before being diagnosed with disease.  Then we obtain disease outcome data and use the latest machine learning computer programs to identify patterns that, with the benefit of hindsight, would have predicted that disease.     


We first applied this methodology--that we brand “20/20 Hindsight”--with tumor antigens  such as CEA, AFP, PSA, etc.  Since tumor markers are used for screening more widely in the East than the West (the notable exception being PSA for prostate screening) most of our data come from that region.   That resulted in our OneTest for Cancer, powered by data from over 200,000 individuals for which outcome data (i.e. whether or not they were diagnosed with cancer within a year or so following their last test).  


There seems to be no reason why this approach cannot be used beyond cancer for chronic ailments like diabetes and heart disease.  In fact, since routine blood tests are more common for those ailments here in the U.S. we are beginning to reach out to American medical institutions to seek data that can be used to train and validate new algorithms to predict heart attacks, etc.   20/20 might even reach out to its 7,500 shareholders who can help us “crowdsource” this data collection.  Please stay tuned for further updates on this effort.  


Please continue to invest to help us modernize laboratory medicine and better help you and your medical providers detect cancer and other diseases early when they can be most effectively treated. Thank you for your continued support!

1st Quarter Revenues Exceed $900,000; Over 600% Growth from Last Year

7 months ago


For the 3 month period ending in March, 20/20's revenue exceeded $950,000 (unaudited) for all products compared to $128,000 during Q'1 last year. Coronavirus associated testing accounted for more than 80% of these revenues, and we expect substantial declines in this testing as "herd immunity" is reached, likely by the second half of this year. But we expect significant growth in cancer test revenues this year targeting at least a 300% increase over last year (i.e. at least $500,000).

Revenues and earnings from Covid-19 testing, coupled with funds raised through StartEngine, will be used to propel our cancer tests as well as new test development and acquisitions.  


COVID-19 Impacts on 20/20’s “New Normal”

8 months ago

As should be clear from our content on this portal, 20/20 went all in on its pandemic response more than 12 months ago.  In March of 2020 we became one of the first companies to clinically validate and make available rapid antibody tests at a time when there were few viable testing alternatives in the U.S.  Later in the year we installed PCR testing equipment in our lab and have now become one of the leading providers of Covid-19 testing for the Montgomery County Maryland Health Department.   Notably Montgomery County is home to the FDA, NIH, and one of the largest life science communities in the country.


What all this means for our long term prospects should be front of mind among those considering an investment in 20/20.  For that we recommend an excellent opinion piece that appeared last week in Barrons by Rahul Dhanda.  See Beyond Covid, the Future of Healthcare Looks Bright for Investors   


This combination of diagnostic tests and vaccines—especially the revolutionary mRNA technologies developed by Moderna and Pfizer/BioNTech—won’t merely end the pandemic. It will revolutionize healthcare and save millions of lives for decades to come...But to realize that potential, the medical community will need to overhaul its approach to diagnostic testing.

Before the pandemic, many doctors considered diagnostics an unnecessary luxury. Just last year, a study in the Open Forum Infectious Diseases journal found that rapid diagnostic tests were used infrequently in outpatient settings at urban safety-net hospitals. An earlier analysis in JAMA Pediatrics found that adolescent Medicaid hypertension patients rarely receive the recommended diagnostic tests.

Even the most elite healthcare providers underuse diagnostic tests. One recent study by researchers at Johns Hopkins University suggests that particularly accomplished physicians may undertest patients as a way of signaling their expertise to fellow practitioners.

Instead of relying on diagnostic tests, many providers play Dr. House. They attempt to diagnose diseases through a trial-and-error process, trying multiple interventions before arriving at an effective treatment, or even an accurate diagnosis...Normalizing the use of diagnostic testing would allow doctors to detect illnesses earlier and treat them more successfully. Consider screenings for cancer, one of the only diseases where diagnostic testing is relatively common. It’s the exception that proves the rule. Widespread use of mammograms probably prevented at least 27,000 breast cancer deaths in 2018 alone.  Imagine if we routinely tested for other infectious diseases with the same urgency as we have for Covid-19. We must continue to invest in and expand diagnostic solutions post pandemic.

Investors would do well to pay attention to advances in this field and stick with the companies making them over the long haul. For the first time, molecular diagnostics is simple enough to be self-administered, allowing point-of-care testing at medical centers—and even in patients’ homes—and creating a $4 billion market for at-home Covid-19 testing almost overnight. An increase in chromosomal abnormalities like Down syndrome is driving the global market for noninvasive prenatal testing. Liquid biopsies, or blood tests that detect several types of early-stage cancer, could soon be a $130 billion market opportunity in the U.S. alone.  (Emphasis ours)

We fundamentally agree with this assessment and believe that 20/20 GeneSystems will continue to be a leader in the application of machine learning powered by real-world data to substantially disrupt laboratory medicine. We encourage you to invest here if you have not done so already. Thank you for your continued support!

Note: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

20/20 Surpasses $10 million in Equity Crowdfunding

8 months ago

20/20 GeneSystems Surpasses Over $10 Million in Total Crowdfunding Investments!


We are pleased to announce that we have exceeded $10,000,000 in total crowdfunding investments over the course of our multiple raises!  To the best of our knowledge no other biotechnology company has raised this much capital from the crowd!  We encourage you to share this link to invest with your friends and family to help us to get to the next level as a company.  Thank you to all of our investors so far for your support!  

This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

20/20 Leases Space for New Headquarters & Lab w/ "Innovation Accelerator"

9 months ago

Last week 20/20 GeneSystems signed a lease for a new, larger office and laboratory facility in Gaithersburg Maryland.  This facility, which will likely be ready for occupancy over the summer, will include larger clinical laboratory infrastructure to accommodate what we anticipate to be expansion and diversification of our lab testing operations that began with Covid-19 testing. 

A unique feature of this transaction was the acquisition of about 1,500 square feet of supplemental space to sublease to start-ups that have developed novel laboratory tests.   Our "Clinical Laboratory Innovation Axcellerator"  or "CLIAx" is likely the first such facility where new tests can be launched using a shared clinical laboratory that is licensed and operated under the rules of the Clinical Laboratory Improvement Amendments (CLIA).   CLIA requires strict adherence to various federal and state regulations on testing personnel and procedures that can be daunting to many start-ups, especially those based overseas.     

20/20 will carefully select sub-tenants from what is expected to be a large pool of applicants to identify those having exciting, scientifically proven tests that can be sold to our growing customer base.  Of particular interest will be tests that aid in the early identification of heart disease, neurological impairments and other ailments where early interventions can improve outcomes.   In short, we expect that over the coming years  CLIAx will help us expand our product pipeline without incurring the significant costs and risks of internally developing all of our future tests.

20/20's Return to StartEngine

9 months ago

Hello StartEngine community,

 

We’re excited to be raising again here on StartEngine. 20/20 GeneSystems has been doing some very impressive things since our last raise here.  Permit us to fill you in on some of the highlights since our last raise:

 

  • Grew our company’s YoY revenues by 700%, largely as a result of pandemic-related testing from 2019 to 2020.  But our core cancer detection business also experienced some growth.
  • Expanded our test menu to address COVID-19, we developed COVID-19 tests including a viral (PCR) test, rapid antibody, antigen tests and a Roche quantitative antibody test
  • Gained traction in the firefighter market - OneTest has been ordered for over 3,500 firefighters including orders from over 30 separate fire departments across 16 states.  This market segment is important since firefighters have proven higher incidences for many tumor types.  

 

  We made some real progress in 2020.  Even more is expected this year.  Please consider becoming a 20/20 shareholder and supporting our lifesaving mission. Please invest in our continued success by clicking here!

 

Thank you.

20/20 Management Team

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