Harbinger Health Showcases Multi-Cancer Early Detection Performance in High-Risk Populations at ASCO 2025

Reflex blood-based multi-cancer early detection (MCED) test demonstrated clinically meaningful per-cancer Positive Predictive Value (PPV) and early-stage sensitivity for multiple cancers with elevated incidence and mortality in a high-risk population

Data to be presented at ASCO’s Clinical Science Symposium on the future of cancer detection

CAMBRIDGE, Mass., May 31, 2025 (GLOBE NEWSWIRE) -- Harbinger Health, a biotechnology company pioneering the detection of early cancer, today announced clinical data demonstrating the performance of its blood-based MCED test across multiple high-incidence, high-mortality cancers, including those disproportionately affecting individuals with obesity, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Results highlight the potential of Harbinger’s ctDNA-methylation-based assay and reflex testing paradigm to address gaps in population-level early cancer detection, particularly for cancers without established screening programs, and in high-risk patient populations with limited clinical guidelines.

“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 Hutan Ashrafian, M.D., Ph.D., M.B.A., 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.”

Harbinger’s test uses specific proprietary methylation patterns of cell-free ctDNA in blood to detect the presence of cancer. The company has developed a platform that combines unique insights into the biology of cancer’s origin with artificial intelligence and analytical and methodological innovations to create novel diagnostic and screening products in multiple clinical settings and cancer indications. Harbinger’s reflex test system uses a two-step approach. The primary methylome profiling test is optimized for high sensitivity to rule out disease. This is followed by a confirmatory reflex test with an expanded methylation panel designed to improve PPV, rule in the presence of cancer, and identify tissue of origin (TOO).

Harbinger conducted the Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study (NCT05435066) with Sarah Cannon Research Institute to validate and further develop Harbinger’s platform. The multi-center, case-controlled study enrolled approximately 8,095 subjects from 126 sites across the U.S. and included two groups: a cancer group of treatment-naïve patients with confirmed diagnoses across 20+ solid and hematologic tumor types, and a non-cancer (control) group of individuals without suspected cancer at enrollment. All participants provided a single blood sample, and controls were followed for one year to confirm their cancer-free status.

Dax Kurbegov, M.D., Senior Vice President at HCA Healthcare Sarah Cannon Cancer Network, will present the findings from the obesity cohort of the CORE-HH study at a Clinical Science Symposium entitled “The Future of Cancer Detection is Coming” from 8:00-9:30 a.m. CDT on Saturday, May 31, 2025, in Hall D1 of the McCormick Place Chicago Convention Center.

Key highlights from the presentation include:

• The test cohort, consisting of 762 individuals with obesity, was assembled from the CORE-HH study and had a mean age of 57.1 ± 13.4 years and were 63.3% female, 22.4% Black or African American, and 67.8% White.
• The distribution of cancer types evaluated in this study was breast, uterine, lung, lymphoid-line, prostate, colorectal, pancreas, upper GI (includes esophageal, esophagogastric junction, and gastric), head and neck, liver, biliary tract, and others.
  • Cancer types grouped under ‘Others’ were not used to train the TOO model due to low sample counts. These include ovarian, renal, anal, neuroendocrine, cervical, melanoma, bladder, myeloid, soft tissue, sarcoma, among others.
• At 98.3% specificity, the reflex test achieved conventional sensitivities of 25.8% for early-stage (I-II) cancer and 80.3% for late-stage (III-IV) cancer.
• At 98.3% specificity, the reflex test achieved a conventional sensitivity of 50.9% for cancers without a screening program in the U.S. general population.
  • Cancers with screening programs in the U.S. general population that were excluded are breast, colorectal, lung, prostate, and cervix.
• Overall intrinsic accuracy - the proportion of correct TOO readouts among cases with a corresponding readout category - was 36%.
• TOO-specific performance as measured by PPV for the following cancers was 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.
  

Dr. Kurbegov commented: “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. Measuring per-cancer PPV, combined with the reflex test design, are novel aspects of Harbinger’s approach that may support stratified diagnostic and follow-up strategies that could help physicians tailor downstream evaluation and management according to the likely tissue of origin and associated benefit-risk considerations. 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. Given these technological advances and study results, I am optimistic that the future of cancer detection is bright and close at hand.”

Obesity is estimated to contribute to ~84,000 new cancer cases in the U.S. annually^1,2, and the incidence of obesity-related cancers has increased substantially over the past two decades³. Thirteen obesity-associated cancers represent ~40% of cancer diagnoses in the U.S.⁴, and most of these cancers, such as pancreatic, liver, and endometrial, do not have screening programs available.

About Harbinger Health

Harbinger Health is leading a transformation in early cancer detection, introducing fundamentally new approaches to screening, diagnosis, and management. The company combines advances in artificial intelligence with proprietary insights into the biology of the beginnings of cancer to identify cancer before it is visible or symptomatic with the aim of developing a low-cost, multi-cancer blood test. Harbinger envisions a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies. Harbinger was founded by Flagship Pioneering after three years of foundational research in its Labs unit and launched in 2020. Learn more about Harbinger by visiting Harbinger-Health.com or following us on LinkedIn.

Media Contact
press@harbinger-health.com

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1. American Association for Cancer Research. Cancer Progress Report 2024
2. Ligibel JA, Alfano CM, Courneya KS, et al. American Society of Clinical Oncology position statement on obesity and cancer. J Clin Oncol. 2014
3. Shiels MS, Haque AT, González AB et al. Trends in Cancer Incidence and Mortality Rates in Early-Onset and Older-Onset Age Groups in the United States, 2010–2019. Cancer Discovery. 2025
4. National Cancer Institute. Obesity and Cancer Fact Sheet. Updated 2022

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