Business Description

Overview We develop and commercialize AI-powered, laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases. We offer two families of lab tests, both under our OneTest brand: (i) OneTest for Cancer, a multi-cancer early detection, or MCED, and (ii) OneTest for Longevity, which measures inflammatory biomarkers, that was launched in February 2026 (the Longevity test is also being branded “OneTest for Workplace Wellness” when marketed to self-insured employers). Both tests are run in our CAP (College of American Pathologists) accredited, CLIA (Clinical Laboratory Improvement Amendments) licensed laboratory in Gaithersburg, MD. This laboratory also hosts our Clinical Laboratory Innovation Accelerator, or CLIAx, which we believe is the country’s first shared CLIA laboratory for overseas diagnostics start-ups seeking to launch novel lab tests in the U.S. without the expense of establishing and operating their own independent lab. Our legacy business also includes a pioneering field test kit for screening suspicious powders for bioterror agents known as BioCheck. For the years ended December 31, 2025 and 2024, sales of OneTest for Cancer accounted for approximately 88% and 85% of our revenues respectively, while sales of BioCheck accounted for approximately 8% and 10% of our revenues, respectively, and our CLIAx accounted for approximately 4% and 5% of our revenues, respectively. Corporate History We were incorporated in the State of Delaware on August 7, 2000 under the name 20/20 BioSystems, Inc. On September 19, 2000, our name was changed to 20/20 Gene Systems, Inc., on June 27, 2021, our name was changed to 20/20 GeneSystems, Inc. and on March 19, 2025, our name was changed to 20/20 Biolabs, Inc. We do not have any subsidiaries. Products OneTest for Cancer The Problem Of the ten deadliest cancers in the U.S., only three — breast, colon, and prostate — have widely adopted screening modalities. This is despite growing evidence that early detection saves or extends lives for cancers of the lung, liver, pancreas, esophagus, and ovaries, which are not yet the subject of widespread asymptomatic screening. The survival rate for the deadliest cancers is closely linked to the stage at the time of diagnosis. With lung cancer, for example, some studies show a five-year survival rate approaching 90% for screen-detected Stage 1 cancers (see Henschke, et al. “Survival of patients with Stage 1 Lung Cancer Detected on CT Screening,” N. Engl. J. Med . 355 (2006)). That survival plummets to under 5% for cancers first diagnosed in Stage 4. To address this void, a few MCEDs have entered the market in recent years and are generating significant enthusiasm among many medical practitioners, policymakers, employers, and consumers. On February 3, 2026, the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act was signed into law. This law creates a pathway for Medicare coverage of MCEDs intended to begin in 2028. As discussed in the sections that follow, we intend to pursue Medicare coverage for our MCED, as we believe it offers compelling advantages over competing tests priced two to three times higher than our OneTest for Cancer. Additionally, on February 26, 2025, the “Firefighter Investments to Recognize Exposure to Cancer Act of 2025 ” was reintroduced as H.R. 1610. If enacted, the legislation would allocate $700 million in grants to American firefighters to receive MCED tests through the Federal Emergency Management Administration, or FEMA. FEMA and several states, including Maryland, New Hampshire, Louisiana, Vermont, and New Jersey, already reimburse their firefighters for obtaining MCEDs, including our OneTest for Cancer (firefighters have proven higher incidence and death rates for several cancers and are a major segment of our customer base). We expect many more states to appropriate funding to reimburse their fire departments for MCED tests like our OneTest for Cancer in 2026 and 2027. 1 This focus on MCEDs has been further bolstered by the activities of high-profile companies offering or developing circulating tumor DNA, or ctDNA, based tests, such as Grail’s Galleri test, following technological advances in next-generation DNA sequencing and machine learning techniques.…