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.
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