20/20 Biolabs, Inc.

20/20 Biolabs, Inc. operates in the clinical laboratory diagnostics industry, specifically developing and commercializing AI-powered, laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases. The company offers two families of lab tests under its OneTest brand: OneTest for Cancer, a multi-cancer early detection (MCED) test, and OneTest for Longevity, which measures inflammatory biomarkers and was launched in February 2026. The company also has a legacy business selling a field test kit for screening suspicious powders for bioterror agents called BioCheck. The company's laboratory in Gaithersburg, MD is CAP accredited and CLIA licensed, and also hosts the Clinical Laboratory Innovation Accelerator (CLIAx), which the company believes is the country's first shared CLIA laboratory for overseas diagnostics start-ups. The industry is shaped by the recent passage of the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act on February 3, 2026, which creates a pathway for Medicare coverage of MCEDs beginning in 2028, and the reintroduction of the FIRE Cancer Act in February 2025, which would allocate $700 million in grants for MCED testing for firefighters. The company positions its OneTest for Cancer as a 'top of funnel' first screening test due to its relatively low cost, higher sensitivity for earlier stage cancers, and ease of access via capillary blood collection.

The company faces significant and growing competition in the MCED space, with most tests using next-generation sequencing to analyze circulating tumor DNA (ctDNA). Primary competitors named in the filing include Grail Inc., which introduced its Galleri test at a price of $949, and Exact Sciences, which acquired Thrive, Inc. for $2 billion and plans to launch its CancerGuard MCED test. The company states that its key competitive advantages, referred to as its 'Straight A’s,' include Affordability (OneTest Standard priced at under $200 versus $950 for Grail’s Galleri), Accuracy for Earlier Stage Cancers (citing studies showing ctDNA-based MCED sensitivity for early-stage cancers is less than 20%), Accessibility (using capillary blood collection), Acceleration Over Time, AI Compatibility, Assists Imaging, and Advisory Expertise. The company believes it is the first and only MCED on the market in the U.S. that is available at a starting price of under $200, can be accessed at home without needles, and has been demonstrated in studies conducted in 2024 by the National Cancer Institute (NCI) to correctly identify significant numbers of otherwise deadly cancers at early stages.

The company generates revenue primarily through the sale of its laboratory-developed tests (LDTs). For the years ended December 31, 2025 and 2024, sales of OneTest for Cancer accounted for approximately 88% and 85% of revenues respectively, sales of BioCheck accounted for approximately 8% and 10% of revenues respectively, and CLIAx accounted for approximately 4% and 5% of revenues respectively. Revenue from OneTest is recognized when serum specimens are analyzed and results are reported to the customer. Revenue from BioCheck kits is recognized upon shipment. Revenue from CLIAx is recognized monthly based on agreed laboratory activities. The company utilizes Business to Business (B2B) and Direct to Consumer (D2C) selling strategies, with key customer segments including fire departments, military veterans, and self-insured employers. The company also has a telemedicine service to authorize tests and consult with patients.

The company's primary product is OneTest for Cancer, an MCED blood test based on a panel of protein tumor markers (PTMs) powered by AI. OneTest Standard is priced at under $200 and reports a proprietary score indicating the likelihood of being diagnosed with cancer within a year. OneTest Premium, introduced in late 2023, includes inflammatory and metabolic biomarkers and calculates the likelihood of eight specific tumor types, priced at $345. The company states that more than two-thirds of all OneTest customers purchase the Premium version. For the year ended December 31, 2025, OneTest revenues were $1,803,707, with a gross margin of 27.38%. The company sold 3,192 Premium Tests and 5,411 Standard Tests during the year ended December 31, 2025. The company's second product family is OneTest for Longevity, an AI-powered blood test to measure and track biomarkers associated with chronic inflammation, launched in February 2026. It is marketed directly to consumers and to self-insured employers under the brand OneTest for Workplace Wellness. The company plans to offer this test for around $189, with subscription discounts of around $39 per month for four quarterly tests per year. The legacy BioCheck product is a field test kit for screening suspicious powders for bioterror agents, generating revenues of $152,047 for the year ended December 31, 2025, with a gross margin of 34.20%. The CLIAx segment generated revenues of $89,379 for the year ended December 31, 2025, with a gross margin of 65.64%.

Significant operational developments during the period include the launch of OneTest for Longevity in February 2026. On January 6, 2025, the company entered into a participation agreement with Ahold Delhaize USA Services LLC, an affiliate of Giant Food, to offer OneTest testing at certain participating locations, agreeing to pay Giant Food $35 per individual participant. On February 14, 2025, the company obtained exclusive rights to utilize the Dietary Inflammatory Index (DII) score through a license agreement with Connecting Health Innovations (CHI), paying a license fee of $30,000. On March 18, 2026, the company entered an exclusive U.S. license agreement with ROKIT Healthcare of Korea to integrate its chronic kidney disease prediction algorithm into the Longevity test platform. The company also raised capital through a private placement of $5 million and convertible debt and bridge financing of $275,000 subsequent to December 31, 2025. On November 17, 2025, the company entered into a securities purchase agreement for a secured convertible promissory note in the principal amount of $295,000 and a warrant to purchase 62,500 shares of common stock for a total purchase price of $250,000. On the same date, the company entered into a Preferred Purchase Agreement for up to $40,000,000 in shares of Series E convertible preferred stock. The company conducted a direct listing on Nasdaq on February 19, 2026. The company also restated its previously issued financial statements for the year ended December 31, 2024 due to errors in accounting for stock-based compensation.

For the fiscal year ended December 31, 2025, total revenues were $2,045,133, an increase of $292,790, or 16.71%, from $1,752,343 in the prior year. Gross profit increased by $244,230, or 67.78%, to $604,541, with gross margin improving to 29.56% from 20.56%. The net loss for the year was $3,738,821, a decrease of $1,812,846, or 32.65%, from a net loss of $5,551,667 in 2024. Operating expenses decreased by $2,102,312 to $3,935,412, driven by a $1,416,744 decrease in sales, general and administrative expenses and a $669,212 decrease in research and development expenses. Cash and cash equivalents as of December 31, 2025 were $1,025,987, down from $1,784,009 at the beginning of the year. Net cash used in operating activities was $1,919,720, compared to $2,598,785 in the prior year.

A primary growth vector is the exploitation of the company's at-home and retail collection advantage, leveraging capillary blood collection for both OneTest for Cancer and OneTest for Longevity. The company plans to expand direct-to-consumer marketing and build additional retail channel partnerships with supermarkets, pharmacies, and health clubs. Another key growth vector is targeting higher-risk populations, specifically firefighters and military veterans. The company expects to expand its fire department customer base from over 200 to over 2,500 departments, roughly 10% of all departments in the U.S. The company also plans to leverage trending federal health initiatives, such as the 'Make America Healthy Again' campaign, to create opportunities for OneTest for Longevity. Strategic partnerships and cooperative advertising are also a key growth vector, with the company initiating an ambitious plan of marketing alliances and partnerships to facilitate scale while mitigating expenses. The company also plans to pursue strategic investments, acquisitions, and transactions through its CLIAx platform.

The company's margin trajectory is expected to benefit from a shift in product mix towards higher-priced Premium Tests. For the year ended December 31, 2025, the gross margin for OneTest improved to 27.38% from 14.00% in the prior year, attributed to the change in product mix. The company's cost of revenues as a percentage of revenues decreased to 70.44% from 79.44%. Sales, general and administrative expenses decreased by 29.77% to $3,342,843, primarily due to optimizing digital marketing campaigns by reducing spending on outside agencies and moving efforts in-house, eliminating redundancies in operating personnel, and reducing overspending on outside accounting services. Research and development expenses decreased by 53.04% to $592,569, as the prior year included significant studies with the NCI and for capillary blood validation, while 2025 activities focused on the Longevity panel.

The company's operational outlook involves expanding its CLIAx capacity to enable investments in or acquisitions of companies with complementary tests or technologies. The company currently performs testing in a single laboratory facility in Gaithersburg, Maryland, and may need to expand or modify this facility or acquire new ones to increase processing capacity. The company has established reagent contracts with Roche and Abbott that guarantee pricing for all immunoassay and chemistry markers, providing supply chain stability. The company has initiated a second source qualification process for most critical components but may not be successful in securing second sourcing for all of them on a timely basis. As of December 31, 2025, the company had a total of 14 employees, including 4 full-time employees.

The company's capital allocation strategy includes significant spending on test validation, biomarker and data acquisitions, data analytics, and algorithm development. Research and development expenses were $592,569 for the year ended December 31, 2025. The company has raised additional funding through a private placement of $5 million and convertible debt and bridge financing of $275,000 subsequent to December 31, 2025. The company has not declared or paid any cash dividends on its common stock and does not anticipate paying any cash dividends in the near future. The company has a stock incentive plan with 3,000,000 shares authorized for issuance. The company also has a Preferred Purchase Agreement with Streeterville Capital, LLC for up to $40,000,000 in shares of Series E convertible preferred stock.

A significant headwind is the company's history of operating losses and its dependence on achieving continued revenue growth that exceeds spending increases. The company's continuation as a going concern is dependent upon achieving this trend and continued financial support from external financing. The company expects patient self-pay to constitute a significant portion of revenues for the foreseeable future, as Medicare coverage is not expected for several years. The commercial potential of OneTest for Longevity is unknown and unproven, and the company does not know the costs of customer acquisition or whether the test will be embraced by the market. The viability of offering automated, tailored coupons for grocery purchases is untested and unproven. The company also faces the risk that the interface between the DII and its laboratory information system has not yet been implemented.

Management has explicitly flagged several constraints to the growth plan. The company will need to attract additional capital to scale its business but has no assurance that it can do so successfully. The company's success will depend heavily on the commercial success of its cancer screening and longevity tests. The company faces substantial competition from more established and better-financed companies. The company's diagnostics tests may not gain market acceptance by physicians and others in the medical community. The company's CLIAx and CLIAx fund might not contribute to its growth. The company's ability to manage growth could harm its business if it cannot effectively manage its growing manufacturing, laboratory operations, and sales and marketing needs.

The company has incurred losses since inception, with a net loss of $3,738,821 ¹ in 2025, and expects to continue generating losses for the foreseeable future, raising substantial doubt about its ability to continue as a going concern. The company's success depends almost entirely on the commercial success of its cancer screening and longevity tests, which have not yet generated significant revenues and face substantial competition from better-financed companies like Grail and Exact Sciences. The company expects patient self-pay to constitute a significant portion of revenues for the foreseeable future, as Medicare coverage is not expected for several years, making revenue growth contingent on individuals' willingness to pay out of pocket. The company has identified material weaknesses in its internal control over financial reporting related to a lack of trained professionals and GAAP technical expertise, which could lead to future restatements and loss of investor confidence. The company's business is subject to extensive and complex healthcare fraud and abuse laws, including the federal Anti-Kickback Statute and the False Claims Act, and any failure to comply could result in significant penalties, including exclusion from government healthcare programs.

Management's message in the filing emphasizes the company's strategic pivot towards its AI-powered blood tests for early detection and prevention, highlighting the recent launch of OneTest for Longevity and the successful direct listing on Nasdaq. The tone is forward-looking and focused on growth, with management stating that the company's 'continuation as a going concern is dependent upon achieving continued revenue growth that exceeds spending increases, a trend that was achieved in 2025.' Management emphasizes three strategic priorities: exploiting the compelling advantage of at-home and retail collections, leveraging trending federal health initiatives like the 'Make America Healthy Again' campaign, and targeting higher-risk populations such as firefighters and military veterans. Management also notes that the company has raised additional funding through a private placement of $5 million and convertible debt and bridge financing of $275,000 subsequent to December 31, 2025, and that the direct listing may enhance access to public capital markets.