Harbinger Wellness Announces Final results Demonstrating Higher-Sensitivity of Early Stage Multi-Cancer Detection Platform at ASCO Annual Meeting 2023

All round sensitivity of early cancer detection for novel blood-primarily based assay was 82% at 95% specificity precise cancer detection prices involve colorectal (96%), lung (85%), prostate (82%) and breast (73%)

Final results, which demonstrate the possible of Harbinger’s biology-informed, AI-driven method, at present getting validated in ten,000-topic CORE-HH clinical trial with the Sarah Cannon Analysis Institute

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

CAMBRIDGE, Mass., May possibly 25, 2023 /PRNewswire/ — Harbinger Wellness, a biotechnology organization pioneering the detection of early cancer, announced right now information demonstrating the company’s biology-informed, AI-driven platform, HarbingerHx, has the possible for extremely sensitive multi-cancer diagnostic accuracy and especially these with early stage cancer. The abstract, “Novel blood-primarily 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 aspect of the 2023 ASCO Annual Meeting held practically and in Chicago, Illinois from June two-six, 2023.

Harbinger Wellness (PRNewsfoto/Harbinger Wellness)

“At Harbinger, we know that early detection is the initially line of defense against cancer,” mentioned Stephen M. Hahn, M.D., CEO of Harbinger Wellness. “These information gave us the conviction in our platform to kind the organization and go just after the huge unsolved trouble of correct, informative early-stage cancer screening. We think we can advance the universally shared objective of minimizing cancer mortality with our blood-primarily based test that combines current genomic and epigenomic discoveries of early cancer with biology-informed artificial intelligence. This is the subsequent step in sophisticated cancer care.”

Abstract Information and Findings

Harbinger generated information from 1,046 subjects, 621 with newly diagnosed, remedy-naive cancer across 15 distinctive forms, and 425 people with no history, diagnosis, or cancer symptoms. Utilizing this sample cohort, the Enterprise created and applied a rigorous framework for predicting the likelihood of cancer employing a multi-layered logistic regression-primarily based machine finding out algorithm, producing final outputs of binary classification (cancer yes/no).

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All round sensitivity of cancer detection was 82% (95% self-confidence interval (CI): 72.7-91.%) at 95% specificity. Notably, the sensitivity was 74% (95% CI: 54.eight-92.7%) for stage 1 and 84% (95% CI: 65.three-one hundred%) for stage two. Additionally, the Enterprise was capable to properly predict cancer in 95% of patient samples with at least .037% tumor fraction. All round sensitivity for higher incident cancers have been breast (73%), prostate (82%), lung (85%), and colorectal (96%) at 95% specificity and the general accuracy of tissue of origin prediction was 86% when the tumor fraction was higher than .1% in the leading three most prevalent cancer forms (breast, colorectal and lung). Importantly, technical variability was introduced when performing assay optimization tactics, but comparable functionality was observed when assessing subsets of stably processed samples, indicating robust functionality.

“As opposed to statistical approaches to recognize informative biomarkers, Harbinger’s method is informed by insights into precise biological events early through tumorigenesis, permitting cancer detection in sufferers with really low levels of circulating tumor DNA,” mentioned Professor Franziska Michor, Ph.D., abstract author, scientific advisor and co-founder of Harbinger Wellness, and Professor of Computational Biology in the Division of Information Science at the Dana-Farber Cancer Institute, in the Division of Biostatistics at the Harvard T.H. Chan College of Public Wellness, and in the Division of Stem Cell and Regenerative Biology at Harvard University. “We are pleased to share this information and appear forward to sharing additional updates as we progress our CORE-HH clinical trial.”

Harbinger’s platform is now getting validated in a ten,000-topic clinical trial, Cancer Origin Epigenetics – Harbinger Wellness (CORE-HH, NCT05435066), in conjunction with the Sarah Cannon Analysis Institute. At present on target to full enrollment by year finish, the CORE-HH study is made to enroll a diverse and representative population with and devoid of cancer at up to 40 U.S. websites.

About Harbinger Wellness

Harbinger Wellness is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis and management. The organization combines advances in artificial intelligence with proprietary insights into the biology of the beginnings of cancer to recognize cancer just before it is visible or symptomatic with the aim of establishing a low-expense, multi-cancer blood test. Harbinger envisions a future exactly where, alternatively of maintaining cancer from spreading, it could be kept from forming, creating a cancer diagnosis a routine wellness trouble to be addressed rather than a life-altering occasion to be feared with profound implications for folks, healthcare systems and societies. Harbinger was founded by Flagship Pioneering just after 3 years of foundational investigation in its Labs unit and launched in 2020. Study much more about Harbinger by going to Harbinger-Wellness.com or following us on Twitter (@harbingerhlth) and LinkedIn.

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