Harbinger Health announced clinical data demonstrating the performance of its blood-based multi-cancer early detection (MCED) test across multiple high-incidence, high-mortality cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The results highlight the potential of the company's ctDNA-methylation-based assay to address gaps in population-level early cancer detection, particularly for cancers without established screening programs and in high-risk patient populations.
Clinical Performance in High-Risk Populations
The reflex blood-based test demonstrated clinically meaningful performance metrics in a cohort of 762 individuals with obesity assembled from the larger CORE-HH study. At 98.3% specificity, the test achieved conventional sensitivities of 25.8% for early-stage (I-II) cancer and 80.3% for late-stage (III-IV) cancer. For cancers without screening programs in the U.S. general population, the test achieved a conventional sensitivity of 50.9% at the same specificity level.
"The results from our study demonstrate the robust early-stage performance of our test across multiple cancer types," said Hutan Ashrafian, M.D., Ph.D., M.B.A., Chief Medical Officer of Harbinger Health. "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."
Novel Intrinsic Accuracy Metric
The study introduced a new performance metric called "intrinsic accuracy," which measures a test's ability to correctly identify both a cancer signal and its tissue of origin (TOO). The overall intrinsic accuracy was 36%, representing the proportion of correct TOO readouts among cases with a corresponding readout category. This metric provides more clinically relevant information compared to conventional sensitivity, which does not indicate the location of cancer within an individual.
TOO-specific performance as measured by positive predictive value (PPV) varied by cancer type: hepatobiliary (15%), upper GI (22%), colorectal (33%), and lung cancer (25%). In a modeled 100,000-person cohort, the test identified 51 of 86 pancreaticobiliary cancers, including 8 of 31 at early-stage.
CORE-HH Study Design and Population
Harbinger conducted the Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study (NCT05435066) with Sarah Cannon Research Institute to validate and develop their platform. The multi-center, case-controlled study enrolled approximately 8,095 subjects from 126 sites across the U.S., including a cancer group of treatment-naïve patients with confirmed diagnoses across 20+ solid and hematologic tumor types, and a non-cancer control group.
The obesity test cohort had a mean age of 57.1 ± 13.4 years and was 63.3% female, 22.4% Black or African American, and 67.8% White. The distribution of cancer types evaluated included breast, uterine, lung, lymphoid-line, prostate, colorectal, pancreas, upper GI (esophageal, esophagogastric junction, and gastric), head and neck, liver, biliary tract, and others.
Technology Platform and Reflex Testing
Harbinger's test uses specific proprietary methylation patterns of cell-free ctDNA in blood to detect cancer presence. The platform combines insights into cancer biology with artificial intelligence and analytical innovations. The reflex test system employs a two-step approach: a primary methylome profiling test optimized for high sensitivity to rule out disease, followed by a confirmatory reflex test with an expanded methylation panel designed to improve PPV and identify tissue of origin.
Addressing Unmet Medical Need
Obesity is estimated to contribute to approximately 84,000 new cancer cases in the U.S. annually, and the incidence of obesity-related cancers has increased substantially over the past two decades. Thirteen obesity-associated cancers represent approximately 40% of cancer diagnoses in the U.S., with most lacking available screening programs.
"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," commented Dax Kurbegov, M.D., Senior Vice President at HCA Healthcare Sarah Cannon Cancer Network, who presented the findings. "These advances solve some of the most confounding challenges we currently face in our ability to make the most of blood-based tools for early cancer detection."
