Harbinger Health Unveils Promising New Data on Early Cancer Detection Platform at AACR 2025

Novel analytical framework establishes a clinically meaningful performance assessment of blood-based early detection tests

Innovative methodology enhances cancer signal detection, boosts specificity and predictive value

Presentations further validate the HarbingerHx platform and its utility in early cancer detection

CAMBRIDGE, Mass., April 25, 2025 (GLOBE NEWSWIRE) — Harbinger Health, a biotechnology company pioneering the detection of early cancer, today announced the presentation of two late-breaking presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois from April 25-30, 2025. Presentations describe innovations that establish both a novel analytical framework and an enhanced laboratory methodology that improve the performance assessment and clinical utility of Harbinger’s blood-based multi-cancer early detection (MCED) tests.

Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis and management by bringing together unique insights into the biology of cancer’s origin with artificial intelligence and the latest screening technologies. The company has developed a platform for developing novel diagnostic and screening products in multiple clinical settings and cancer indications.

“While innovations in cancer therapy have revolutionized the treatment landscape, the tools to detect and diagnose it early when survival rates are highest have lagged behind,” said Hutan Ashrafian, M.D., Ph.D., M.B.A, Chief Medical Officer. “At Harbinger, our mission is to disrupt conventional cancer detection approaches that either lack an appropriately high diagnostic accuracy for clinically impactful outcomes or only provide detection for a single cancer at a time. By pioneering blood-based tests based on DNA methylation signatures with novel applications including sequential reflex testing and individualized analyses, we aim to provide solutions that give physicians highly accurate and reliable information to get their patients on the right treatment pathways, right away. The data presented today underscore our commitment to setting a new standard in quantifying test performance, with the ultimate goal of adequately informing earlier clinical intervention and improving outcomes for patients across a wide spectrum of cancers.”

Harbinger conducted the Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study (NCT05435066) to support the continued development and validation of Harbinger’s platform technology for the detection of early-stage disease across multiple cancer types. The primary objectives of the case-controlled study, which enrolled a diverse and representative cohort of individuals with and without cancer, included evaluating the diagnostic accuracy of its proprietary assay and assessing its ability to determine cancer tissue of origin. Data and samples collected as part of CORE-HH formed the basis for the development and evaluation of the novel analytical framework and methodology presented at the AACR Annual Meeting 2025.

Key highlights from the late-breaking presentations include:

Title: Sharpening the signal: Enhancing liquid biopsy specificity through intra-individual methylation analysis
Date: Tuesday, April 29, 2025
Time: 9:00 a.m. – 12:00 p.m. CT in Section 51
Key Highlights:

• A methodology based on Harbinger’s proprietary methylation biomarkers and a paired intra-individual analysis (IIA)—comparing plasma-derived cell free DNA (cfDNA) to matched white blood cell (WBC)-derived genomic DNA (gDNA)—was developed and tested on CORE-HH data, to differentiate circulating tumor DNA (ctDNA) from background somatic noise.
• Harbinger combined two approaches: a cfDNA-based machine learning classifier (MLX) and a patient-specific intra-individual classifier (IIX), integrating them into a two-tier system. Together, these methods achieved higher overall specificity than either approach alone.
• When MLX and IIX were both set to a target specificity of 98.5%, the achieved sensitivity and specificity was 63.7% and 99.5% with a PPV of 54.8%,
• When MLX and IIX were both set to target specificities of 99.5%, the achieved sensitivity and specificity was 55.1% and 99.89% with a Positive Predictive Value (PPV) of 80.7%.

Title: Novel performance quantification of MCED testing to aid clinical decisions: Analysis of a sequential reflex blood-based methylated ctDNA test
Date: Tuesday, April 29, 2025
Time: 9:00 a.m. – 12:00 p.m. CT in Section 51
Key Highlights:

• A novel framework was developed for the performance assessment of MCED testing and applied to data from the CORE-HH study, quantifying clinically meaningful and actionable metrics relevant to real-world utility.
• The test achieved a specificity of 98.6%, representing an important benchmark for population-level screening resulting in a low false-positive rate critical to minimizing downstream diagnostic burden.
• Results demonstrate promise for the test to detect certain cancers currently lacking organized screening programs in the general population such as pancreaticobiliary (identification of 32 of 49 cases) and hepatobiliary cancer.
• Cancers with very high Positive Predictive Values (PPV) — upper gastrointestinal (91%), colorectal (77%), and hepatobiliary cancers (73%) — demonstrate exceptionally favorable risk-benefit profiles, as the high likelihood of true disease minimizes unnecessary interventions.

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.

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