20/20 BioLabs argues a tiered screening approach—starting with protein-based tests before moving to circulating tumor DNA testing or imaging—could improve early-stage detection and lower costs.
20/20 BioLabs is highlighting what it describes as key advantages of its patented protein tumor marker (PTM)-based, machine learning-derived multi-cancer early detection (MCED) methodology, pointing to recent studies suggesting the approach may offer earlier-stage detection compared to stand-alone circulating tumor DNA (ctDNA)-based tests.
The Gaithersburg, MD-based company’s comments come in the wake of results published in February 2026 from a large-scale ctDNA-based MCED study conducted in the UK, which the company says has prompted broader discussion about the biological limitations of ctDNA as a first-line screening tool for early-stage disease.
According to 20/20 BioLabs, ctDNA-based tests face a fundamental biological constraint. In early-stage cancers, where tumor burden is low, DNA shedding into the bloodstream is often intermittent or absent. As a result, the company says, ctDNA signals may only become reliably detectable after disease has progressed beyond the window of greatest clinical impact.
“The UK 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,” says Michael Lebowitz, PhD, chief scientific officer of 20/20 BioLabs, in a release. “A scalable future for population screening will likely combine technologies, with sensitive protein biomarkers identifying risk earlier and genomic assays providing confirmatory precision.”
A Tiered Screening Model
20/20 BioLabs is advocating for a multi-step screening approach in which its protein biomarker-based OneTest for Cancer serves as an initial screening tool before patients are directed to ctDNA testing or advanced imaging platforms.
Under the model proposed by the company, individuals identified as being at mild risk by a protein-based test would then be directed into ctDNA-based testing within a three-to-six-month window, when ctDNA signals are more likely to be present. Those deemed at higher risk by protein-based tests, the company says, would be better served by moving directly to imaging studies.
“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,” says Lebowitz, in a release. “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.”
The company says studies published by 20/20 BioLabs and several independent research groups in the US and Asia over the past 10 months add to a growing body of evidence supporting its PTM-based approach for earlier-stage detection, building on hundreds of studies conducted over several decades.
Medicare Coverage Pathway
The company also notes that Congress passed legislation in February 2026 to create a pathway for Medicare coverage of MCEDs beginning in 2028, and says it intends to work with policymakers, regulators, and payers to ensure protein-based technologies are included in coverage decisions.
“The reimbursement opportunity created by the new legislation is an important step forward for cancer screening access,” says Jonathan Cohen, chief executive officer of 20/20 BioLabs, in a release. “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.”
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