Protein Biomarkers May Play an Important Role in Overcoming Limitations of Circulating Tumor DNA for Screening Early-Stage Cancers
GAITHERSBURG, M.D., March 12, 2026 (GLOBE NEWSWIRE) — 20/20 BioLabs (Nasdaq: AIDX), an early market entrant in cutting-edge, AI powered laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, today provided an update on its patented protein tumor marker (PTM) based, machine learning (ML) derived multi-cancer early detection (MCED) methodology in the wake of several recent studies suggesting the expected value of this approach for earlier stage detection compared to stand-alone circulating tumor DNA (ctDNA) based MCEDs.
As population-scale cancer screening studies continue to generate trial data and real-world evidence, the medical community, consumers, investment community, and scientific experts are increasingly focused on which MCEDs and biomarker modalities are best suited to detect cancers early enough to meaningfully change patient outcomes. Results reported in February 2026 from a large-scale ctDNA-based MCED study conducted in the U.K. has prompted broader discussion about the biological limitations of circulating tumor DNA as first-line screening tests for early-stage disease.
Generally, for MCED tests to be clinically meaningful, they must detect cancer early enough to change outcomes. Among other things, this requires biomarkers that are present and detectable before tumors shed sufficient DNA into the bloodstream. Circulating tumor DNA (ctDNA)-based tests, while valuable in detecting advanced disease, face a fundamental biological constraint: in early-stage cancers, where tumor burden is low, DNA shedding is often intermittent or absent. As a result, ctDNA signals may only become reliably detectable after disease has progressed beyond the window of greatest clinical impact.
“The U.K. trial confirms that MCED blood testing can meaningfully shift the stage of cancer diagnosis. However, it also underscores that detecting the earliest cancers remains a fundamental biological challenge for ctDNA-based tests, as cancer biology does not begin with DNA fragment release in the bloodstream,” said Michael Lebowitz, Ph.D., Chief Scientific Officer of 20/20 BioLabs. “A scalable future for population screening will likely combine technologies, with sensitive protein biomarkers identifying risk earlier and genomic assays providing confirmatory precision.”
Studies published by 20/20 Biolabs and several independent research groups in the U.S. and Asia over the past 10 months add to the growing body of evidence that our company’s patented multi-cancer testing approach may help overcome many of the limitations of ctDNA for earlier stage detection:
- In May 2025 20/20 Biolabs presented data on the sensitivity of its OneTest for Cancer (Premium version) at the annual meeting of the U.S. National Cancer Institute’s (NCI) Early Detection Research Network (EDRN), demonstrating detection rates for early-stage cancers as high as 50% for some tumor types — including pancreatic and ovarian cancers — from a pre-diagnostic (asymptomatic) population using a blinded cohort supplied by the NCI. (EDRN Poster May 2025)
- Additional support for using protein tumor markers comes from a large, multicenter validation study published in Nature’s Precision Oncology in October 2025, which evaluated an AI enhanced blood test integrating seven well established protein tumor markers (6 of which are part of OneTest) across more than 15,000 participants from seven centers in three countries (USA, China, and Brazil). The study demonstrated consistent cancer signal detection across diverse populations, with measurable sensitivity even in Stage I disease and progressively higher detection rates as cancers advanced.
- In a blinded validation study published in November 2025, investigators at MD Anderson Cancer Center reported that a protein based multicancer test—with most of the same biomarkers measured in OneTest (Standard version)—identified nearly 90% of early stage lung cancers and flagged multiple other cancers a median of 12–21 months prior to diagnosis, supporting the sensitivity of protein tumor markers during early oncogenesis.
These recent reports build upon hundreds of studies over several decades showing the sensitivity of PTMs for early-stage detection of many different tumor types, especially following repeat (serial) testing. This evolving evidence reinforces the scientific and commercial rationale for large scale screening first with its protein biomarker-based OneTest for Cancer test prior to considering the more costly ctDNA tests or advanced imaging platforms.
“Given the higher sensitivity of protein-based tests for Stage I and II cancers, a tiered approach in which protein-based tests like OneTest serve as the initial screening step makes sense,” suggests Dr. Lebowitz. “Individuals identified by protein-based tests to be at mild risk can then be directed into ctDNA-based testing within a 3–6-month window, when ctDNA signals are more likely to be present. We believe those deemed at higher risk by protein–based tests are likely better served by moving directly to imaging studies. This tiered, or multi-step, approach is likely to yield the best outcomes and the lowest costs.”
Results from the ctDNA MCED trails in the U.K. come shortly after Congress passed legislation in February 2026 to create a pathway for Medicare coverage of MCEDs beginning in 2028.
“The reimbursement opportunity created by the new legislation is an important step forward for cancer screening access,” said Jonathan Cohen, CEO of 20/20 BioLabs. “As coverage decisions are made, we believe the science supports a broader view of MCED — one that includes protein-based technologies that have demonstrated meaningful early-stage detection. We are committed to continuing to build the evidence base and to working with policymakers, regulators, and payers to ensure that the most meaningful and cost-effective screening tools are readily available to Americans.”
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, which measures inflammatory biomarkers, expected to launch in the first half of 2026. OneTest’s affordable, accurate, actionable tests can be conveniently accessed at home using new, upper arm collection devices that avoid painful needles. Tests are run in its College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory in Gaithersburg, MD.
20/20 BioLabs’ pioneering Clinical Laboratory Innovation Accelerator, or CLIAx, is a shared CLIA laboratory for overseas diagnostics start-ups seeking to launch novel lab tests in the US without the expense of establishing and operating their own, independent lab. The Company’s legacy business also includes a pioneering field test kit for screening suspicious powders for bioterror agents known as BioCheck. For more information visit 2020biolabs.com.
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Investor Relations
Chris Tyson
MZ Group
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