20/20 BioLabs Highlights Investor Webinar Focused on OneTest™ for Medicare, Serial Biomarker Tracking, and Strong Q2 Revenue Growth

Company Outlines Strategy to Position OneTest™ as the First Affordable, Multi-Cancer Early Detection Blood Test for Earlier Stage Detection

GAITHERSBURG, Md., July 09, 2026 (GLOBE NEWSWIRE) -- 20/20 BioLabs, Inc. (NASDAQ:AIDX) (the "Company"), an early market entrant in AI-powered, laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, today highlighted key themes from its inaugural investor webinar held on July 1, 2026. The Company presented its strategy for advancing OneTest™ for Cancer toward potential Medicare reimbursement under the new statutory pathway for FDA-authorized multi-cancer early detection ("MCED") blood tests beginning in 2028.

The Company highlighted recent federal legislation creating a Medicare coverage pathway for MCED tests, together with evolving clinical evidence and real-world screening data, which may create a significant long-term opportunity for affordable, accessible MCED testing. The Company emphasized that Medicare reimbursement for OneTest™ would require FDA authorization and a CMS determination of clinical appropriateness, neither of which has been obtained, and there can be no assurance that such authorization, coverage, or reimbursement will be achieved whatsoever.

During the presentation, the Company demonstrated how OneTest™ differs from circulating tumor DNA-based MCED approaches by using a panel of protein tumor markers, inflammation-associated biomarkers, machine learning, and serial testing to monitor biomarker trajectories over time rather than relying on a single snapshot. The Company believes this approach may support earlier detection, improved specificity through trend analysis, and more practical repeat testing using at-home capillary blood collection.

The Company also detailed its evidence-generation strategy, including the use of real-world screening data, international clinical datasets, published "look-alike" protein tumor marker panel studies, potential validation using banked U.S. biospecimens, and outcomes from high-risk populations such as firefighters. The Company noted that more than 35,000 American firefighters are expected to have been tested by the end of 2026. The Company expects this population to provide important real-world data to support its regulatory and reimbursement strategy. The Company also indicated that its second quarter MCED revenue is expected to be its highest to date, and at least 30% higher than the prior-year second quarter (three months ended June 30, 2025). These estimates are based on preliminary numbers that have not yet been reviewed by our auditors.

"We believe our inaugural investor webinar helped clarify why OneTest™ may be well positioned for the emerging MCED reimbursement landscape," said Jonathan Cohen, Chief Executive Officer of the Company. "Our strategy is to combine an affordable protein biomarker test, AI-enabled longitudinal analysis, convenient at-home collection, and real-world evidence from large screening populations. While substantial regulatory and reimbursement work remains, we believe this approach offers a differentiated path toward making multi-cancer early detection more accessible to Medicare beneficiaries and other large populations."

The presentation further highlighted the Company’s OneTest™ for Longevity platform, which integrates inflammatory biomarkers, dietary assessment tools, and personalized health insights. The Company discussed how repeat testing and dietary-inflammatory scoring may complement the Company’s broader prevention-focused strategy, including potential alignment with federal initiatives focused on nutrition, chronic disease prevention, and health optimization.

Webinar Highlights

• Congress has created a statutory pathway for Medicare reimbursement of FDA-authorized MCED blood tests beginning in 2028, subject to CMS clinical appropriateness criteria.
• The Company believes OneTest™ may be differentiated by affordability, serial biomarker tracking, strong sensitivity for many earlier stage cancers, machine learning, protein tumor markers, and practical at-home collection.
• The webinar reviewed concerns by experts about the clinical utility profile of certain ctDNA-only approaches for broad population screening, including recent randomized trial data from a large U.K. study.
• The Company described a totality-of-evidence strategy intended to support future FDA and CMS engagement, including analytical validity, clinical validity, published studies, real-world evidence, and prospective outcome follow-up.
• The Company discussed its M&A strategy targeting companies with overlapping health, wellness, early cancer detection, longevity testing, and nutrition-related customer bases.
  
  

The investor webinar presentation included modeled sensitivity and specificity estimates and revenue projections that are hypothetical illustrations based on assumptions described in the presentation. These estimates and projections are not measured trial results, are not guarantees of future clinical or financial performance, and should not be relied upon as predictions of actual outcomes. The presentation is available through the Company’s investor relations materials.

About 20/20 BioLabs

20/20 BioLabs, Inc. (NASDAQ:AIDX) develops and commercializes 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 the OneTest brand. OneTest™ for Cancer is a multi-cancer early detection, or MCED, blood test, and OneTest™ for Longevity measures inflammatory biomarkers and is commercially available. OneTest’s affordable, accurate, accessible tests can be conveniently utilized at home using new, upper-arm capillary collection devices that avoid painful needles. Tests are run in the Company’s College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory in Gaithersburg, Maryland.

For more information visit https://2020biolabs.com.

Forward-Looking Statements

Certain statements in this release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that it believes may affect its financial condition, results of operations, business strategy, regulatory strategy, reimbursement strategy, and financial needs. Forward-looking statements can be identified by words such as "may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project," "continue," or the negative of these terms or other comparable expressions.

Forward-looking statements in this release include, but are not limited to, statements regarding the Company’s expectations regarding the MCED reimbursement landscape, potential FDA authorization, potential CMS coverage or reimbursement, clinical utility, real-world evidence generation, the potential value of firefighter screening data, the potential performance of serial biomarker tracking and machine learning algorithms, the Company’s M&A strategy, and the potential market opportunity for OneTest™. Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various factors, including the risks described in the Company’s filings with the U.S. Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 10-K.

OneTest™ for Cancer has not received FDA De Novo authorization or premarket approval and is currently offered as a laboratory-developed test in the Company’s CLIA-licensed and CAP-accredited laboratory. Medicare reimbursement under the Multi-Cancer Early Detection Screening Coverage Act requires FDA authorization and a CMS determination of clinical appropriateness. There can be no assurance that the Company will obtain FDA authorization, CMS coverage, CMS reimbursement, or any other regulatory, clinical, commercial, or financial outcome on any particular timeline, or at all. The Company undertakes no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events, except as required by applicable law.

Investor Relations

Chris Tyson

MZ Group

Direct: 949-491-8235

AIDX@mzgroup.us