Blood-Based Cancer Detection Test Shows Promise in High-Risk Populations
Dax Kurbegov, MD, discusses findings from the CORE-HH study that build on growing evidence to support the clinical feasibility of blood-based early detection tools.
At the 2025 American Society of Clinical Oncology Annual Meeting Annual Meeting, new data from the CORE-HH study (NCT05435066) highlighted the potential of Harbinger Health’s methylation-based multi-cancer early detection (MCED) test to identify cancer in high-risk populations, particularly individuals with obesity. Presented by Dax Kurbegov, MD, senior vice president at HCA Healthcare Sarah Cannon Cancer Network, of the Sarah Cannon Research Institute, the findings build on growing evidence supporting the clinical feasibility of blood-based early detection tools.
Harbinger’s novel assay analyzes methylation patterns in cell-free circulating tumor DNA and uses a two-step reflex testing process, starting with a high-sensitivity screen followed by a confirmatory test that improves specificity and identifies tissue of origin.
“This study adds to the body of evidence that these blood-based detection strategies are feasible, are practical, and can be associated with clinically meaningful outcomes,” said Kurbegov. “These tests do detect cancers and are likely to perform better in higher-risk populations.”
The obesity-focused cohort, drawn from the 8095-participant CORE-HH study, included 762 individuals with a mean age of 57 years. The analysis showed 25.8% sensitivity for early-stage (I-II) cancers and 80.3% for late-stage (III-IV) cancers, with 98.3% specificity. For cancers lacking standard screening protocols—such as pancreatic, upper gastrointestinal, and liver—the test achieved 50.9% sensitivity.
Kurbegov emphasized the importance of these findings: “We do now have potentially an answer to look at those who may carry risk for other than traditional screen cancers… a conversation around the risks and benefits of testing in these groups is not an unreasonable conversation to have.”
In modeled projections, the test detected 51 of 86 pancreaticobiliary cancers, including 8 early-stage cases. While current tissue of origin accuracy remains modest (36%), the platform demonstrated positive predictive value ranging from 15% to 33% for high-mortality cancers.
Looking forward, Kurbegov underscored a key challenge: “You run a study that’s going to take 8-10 years, and 2 years in, your original assay is out of date… real-world evidence is going to be an important part of this future story.”
