Harbinger Health has presented clinical data showing how its blood-based multi-cancer early detection (MCED) test performs in individuals at increased risk of cancer, including those with obesity. The results, shared at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, suggest the test may offer an effective screening alternative for cancers that currently lack early detection programs.

The test uses a reflex-based approach combining methylation profiling of circulating tumor DNA with artificial intelligence to improve early-stage sensitivity and enhance tissue-of-origin (TOO) accuracy. Harbinger says this method is particularly relevant for high-mortality cancers where conventional screening is limited or absent.

“The results from our study demonstrate the robust early-stage performance of our test across multiple cancer types. While the obesity-associated subset demonstrates our ability to target high-risk groups, the broader results underscore the platform’s potential across a wide range of deadly cancers that lack mechanisms for effective, large-scale early detection via routine screening,” said Dr Hutan Ashrafian, chief medical officer of Harbinger Health. “The analysis that we are presenting at ASCO validates the alignment between our test performance and disease burden and reflects our commitment to designing a test for those who need it most, when it matters most.”

The data come from the Cancer ORigin Epigenetics–Harbinger Health (CORE-HH) study, conducted in collaboration with Sarah Cannon Research Institute. The multi-centre, case-controlled study enrolled over 8,000 participants from 126 US sites. Subjects included individuals with confirmed diagnoses of more than 20 cancer types, and cancer-free individuals who were followed for a year post-enrolment.

Dr Dax Kurbegov, senior vice president at HCA Healthcare’s Sarah Cannon Cancer Network, presented results from the obesity subgroup of 762 individuals. Among this cohort, early-stage cancer sensitivity was 25.8% and late-stage sensitivity reached 80.3% at a specificity of 98.3%. For cancers without current US screening programs, such as pancreatic, liver and uterine cancers, sensitivity was 50.9%.

The study introduced a new metric for intrinsic accuracy, defined as the proportion of correct TOO readouts among cases with a corresponding category. Across the test cohort, intrinsic accuracy was 36%. Positive predictive values for TOO identification were 15% for hepatobiliary cancers, 22% for upper gastrointestinal, 33% for colorectal and 25% for lung cancers.

“These data introduce for the first time a metric for intrinsic accuracy to measure a test’s ability to correctly identify both a cancer signal and its tissue of origin. This is a more stringent and clinically relevant result as compared to conventional sensitivity, which has been the current industry standard and does not provide information on the location of cancer within an individual,” said Dr Kurbegov. “Given these technological advances and study results, I am optimistic that the future of cancer detection is bright and close at hand.”

Obesity-related cancers remain a major concern in the US, with estimates suggesting they account for around 84,000 new cases annually. Thirteen obesity-associated tumor types comprise nearly 40% of all cancer diagnoses, yet many—including pancreatic, liver and endometrial cancers—are not routinely screened for.

Harbinger’s reflex test system aims to address this by ruling out disease in the first step and using a second-stage test to improve positive predictive value and localize the cancer’s origin, helping inform follow-up strategies.