About 20/20 GeneSystems
20/20 GeneSystems, Inc. is a U.S. based privately held corporation based in Maryland. Investment in the company is currently open for Angel, Private and Institutional investors. Investors are invited to review our current investment offering. 20/20 GeneSystems is offering investments to verified accredited investors. Prospective investors interested in learning more about the company and its products, including the risks of investing, should contact us.
Information on our website has has been prepared in good faith by the Company. With respect to the projections, forecasts, pricing, sales, budget, and market information contained in the Overview, the Company represents only that such information was prepared in good faith and that the Company believes that there is a reasonable basis for such information. Although the information on our website is believed by the Company to be complete and accurate, all such information is subject to change at any time, and the Company expressly disclaims any and all liability for any information, representations or statements (express or implied) contained in, and/or for any omissions.
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.
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.
For detailed information on the accuracy of OneTest, please visit our website https://onetestforcancer.com/learn/. Then, click the “Accuracy, Reliability & Scientific Support” tab.
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.
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.
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.