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., the tests are paid for by employers and the individual consumer, not insurance plans. While do not expect the major insurance plans to cover OneTest any time soon, most HSA / Flex spending accounts can be used for payment.

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 is instead regulated by the Center for Medicare & Medicaid Services (CMS) and the Maryland Department of Health 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. When the test volume begins to exceed the capacity of our CLIA lab we expect to then seek FDA approval so that the tests can be run in other labs. Real-world outcome data (i.e. the numbers of true cancers detected early with the aid of this test vs. false alarms) from a statistically significant number of Americans (e.g. 50,000) will be used in support of this regulatory approval application. We therefore seek the assistance of the consumers of this test and their healthcare providers to assist us in collecting reliable outcome data. Until then, the results of the algorithms, which were derived mainly from an overseas population, should be used with caution.

The automated instruments that we use in our CLIA lab are approved by the FDA and the detection kits are also approved for various. PSA is approved for screening for prostate cancers. The other biomarker detection kits are approved for assisting in diagnosing cancer, monitoring cancer recurrence, and / or therapeutic monitoring. However, several foreign counterparts to the FDA have approved these biomarker test kits for use in screening and early detection resulting in these tests being employed in those countries for the yearly screening of tens of millions of individuals.

Studies by Rafael Molina, Chair of the European Group on Tumor Markers, show little to no variability between European and Chinese populations for most of the biomarkers in OneTest. See e.g. Molina etc. Tumor Biology, April 2018: 1–13.

The only cancers widely screened for in the U.S. those of the colon, prostate (for men), and breast and cervix (for women). We believe that OneTest can help with the early detection of far more cancer types. OneTest should not be used as an alternative to tests that your doctor or leading medical organization recommend such as colonoscopy or mammogram.

We currently assess the levels of tumor antigens which is the standard in cancer screening blood tests around the world. These currently include AFP, CEA, CA-125, CA19-9, CYFRA21-1 for both genders as well as PSA for men only and CA-15-3 for women. Published reports from screening centers in East Asia have demonstrated the usefulness of these biomarkers for detecting several tumor types early. However, 20/20 seeks to improve the accuracy of stand-alone biomarker testing by incorporating algorithms that factor in changes to biomarker levels over time as well as chronic condition that may cause false positives.

We do not currently look for inherited genetic mutation as they contribute to only about five percent of the mutations that cause most cancers. However, in the future we might include circulating tumor DNA if this approach an be validated for use in early detection.

In health check clinics where these biomarkers are commonly tested follow-up usually involve repeat testing of those biomarkers that are high or borderline as well as imaging test such as ultrasound, colonoscopy, CT, PET, and bone scans, etc. Yearly testing is recommended based on studies with ovarian, pancreatic, and colon cancers.