Harbinger Health Announces Results Demonstrating High-Sensitivity of Early Stage Multi-Cancer Detection Platform at ASCO Annual Meeting 2023

Overall sensitivity of early cancer detection for novel blood-based assay was 82% at 95% specificity; specific cancer detection rates include colorectal (96%), lung (85%), prostate (82%) and breast (73%)

Results, which demonstrate the potential of Harbinger’s biology-informed, AI-driven approach, currently being validated in 10,000-subject CORE-HH clinical trial with the Sarah Cannon Research Institute

Findings published in the 2023 ASCO Annua Meeting Proceedings, a Journal of Clinical Oncology supplement

Cambridge, Mass., May 25, 2023 – Harbinger Health, a biotechnology company pioneering the detection of early cancer, announced today data demonstrating the company’s biology-informed, AI-driven platform, HarbingerHx, has the potential for highly sensitive multi-cancer diagnostic accuracy and specifically those with early stage cancer. The abstract, “Novel blood-based assay for detection of early stage multi-cancer,” was published in the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings, a Journal of Clinical Oncology supplement, as part of the 2023 ASCO Annual Meeting held virtually and in Chicago, Illinois from June 2-6, 2023.

“At Harbinger, we know that early detection is the first line of defense against cancer,” said Stephen M. Hahn, M.D., CEO of Harbinger Health. “These data gave us the conviction in our platform to form the company and go after the big unsolved problem of accurate, informative early-stage cancer screening. We believe we can advance the universally shared goal of reducing cancer mortality with our blood-based test that combines recent genomic and epigenomic discoveries of early cancer with biology-informed artificial intelligence. This is the next step in advanced cancer care.”

Abstract Details and Findings

Harbinger generated data from 1,046 subjects, 621 with newly diagnosed, treatment-naive cancer across 15 different types, and 425 individuals with no history, diagnosis, or cancer symptoms. Using this sample cohort, the Company developed and applied a rigorous framework for predicting the likelihood of cancer using a multi-layered logistic regression-based machine learning algorithm, generating final outputs of binary classification (cancer yes/no).

Overall sensitivity of cancer detection was 82% (95% confidence interval (CI): 72.7-91.0%) at 95% specificity. Notably, the sensitivity was 74% (95% CI: 54.8-92.7%) for stage 1 and 84% (95% CI: 65.3-100%) for stage 2. Furthermore, the Company was able to correctly predict cancer in 95% of patient samples with at least 0.037% tumor fraction. Overall sensitivity for high incident cancers were breast (73%), prostate (82%), lung (85%), and colorectal (96%) at 95% specificity and the overall accuracy of tissue of origin prediction was 86% when the tumor fraction was greater than 0.1% in the top 3 most prevalent cancer types (breast, colorectal and lung). Importantly, technical variability was introduced when performing assay optimization strategies, yet comparable performance was observed when assessing subsets of stably processed samples, indicating robust performance.

“Unlike statistical approaches to identify informative biomarkers, Harbinger’s approach is informed by insights into specific biological events early during tumorigenesis, allowing cancer detection in patients with very low levels of circulating tumor DNA,” said Professor Franziska Michor, Ph.D., abstract author, scientific advisor and co-founder of Harbinger Health, and Professor of Computational Biology in the Department of Data Science at the Dana-Farber Cancer Institute, in the Department of Biostatistics at the Harvard T.H. Chan School of Public Health, and in the Department of Stem Cell and Regenerative Biology at Harvard University. “We are pleased to share this data and look forward to sharing further updates as we progress our CORE-HH clinical trial.”

Harbinger’s platform is now being validated in a 10,000-subject clinical trial, Cancer Origin Epigenetics – Harbinger Health (CORE-HH, NCT05435066), in conjunction with the Sarah Cannon Research Institute. Currently on target to complete enrollment by year end, the CORE-HH study is designed to enroll a diverse and representative population with and without cancer at up to 40 U.S. sites.

About Harbinger Health

Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer 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 Twitter (@harbingerhlth) and LinkedIn.

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