Harbinger Health unveiled clinical data for its blood-based multi-cancer early detection (MCED) test at the 2025 ASCO Annual Meeting. The data highlights the test’s potential for early detection of multiple high-incidence cancers, especially those impacting individuals with obesity, and addresses the current lack of screening programs for several cancer types. The research specifically focused on cancers with elevated incidence and mortality rates in high-risk populations.
This development is a potential turning point in cancer management, particularly for cancers linked to obesity, which often lack effective screening methods. Early detection dramatically improves patient outcomes and survival rates. The data suggests this technology could offer a much-needed solution for addressing the growing incidence of obesity-related cancers and potentially reducing cancer mortality. This test’s focus on high-risk populations demonstrates a significant step towards personalized medicine, offering tailored solutions for specific patient groups.
The CORE-HH study, conducted with Sarah Cannon Research Institute, involved over 8,000 participants and evaluated the test’s performance across 20+ cancer types. In a subset of individuals with obesity, the reflex test demonstrated 98.3% specificity with 25.8% sensitivity for early-stage (I-II) cancers and 80.3% for late-stage (III-IV) cancers. Importantly, the test showed 50.9% sensitivity for cancers lacking established screening programs. Preliminary data suggests an intrinsic accuracy of 36% for correctly identifying both a cancer signal and its tissue of origin, a more clinically relevant metric. Positive Predictive Values (PPV) were also reported for specific cancer types, including hepatobiliary, upper GI, colorectal, and lung.
The ability to accurately identify both the presence and location of cancer through a simple blood test could revolutionize early cancer detection. This approach offers potential for streamlined diagnosis, personalized treatment strategies, and improved resource allocation. Future research and larger validation studies will be essential to confirm these findings and integrate this technology into routine clinical practice. The data presented suggests a promising future for early cancer detection and management, with potential implications for both individual patient care and broader population health.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
