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

Outcomes, which demonstrate the prospective of Harbinger’s biology-informed, AI-driven method, at the moment becoming validated in ten,000-topic CORE-HH clinical trial with the Sarah Cannon Study Institute

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

CAMBRIDGE, Mass., Could 25, 2023 /PRNewswire/ — Harbinger Wellness, a biotechnology corporation pioneering the detection of early cancer, announced currently information demonstrating the company’s biology-informed, AI-driven platform, HarbingerHx, has the prospective for extremely sensitive multi-cancer diagnostic accuracy and particularly 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 component 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 type the corporation and go right after the huge unsolved difficulty 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 Particulars and Findings

Harbinger generated information from 1,046 subjects, 621 with newly diagnosed, therapy-naive cancer across 15 unique varieties, and 425 men and women with no history, diagnosis, or cancer symptoms. Applying this sample cohort, the Business created and applied a rigorous framework for predicting the likelihood of cancer employing a multi-layered logistic regression-primarily based machine studying 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. In addition, the Business was capable to appropriately predict cancer in 95% of patient samples with at least .037% tumor fraction. All round sensitivity for higher incident cancers had been breast (73%), prostate (82%), lung (85%), and colorectal (96%) at 95% specificity and the all round accuracy of tissue of origin prediction was 86% when the tumor fraction was higher than .1% in the top rated three most prevalent cancer varieties (breast, colorectal and lung). Importantly, technical variability was introduced when performing assay optimization approaches, but comparable efficiency was observed when assessing subsets of stably processed samples, indicating robust efficiency.

“As opposed to statistical approaches to recognize informative biomarkers, Harbinger’s method is informed by insights into certain biological events early in the course of tumorigenesis, enabling cancer detection in individuals 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 becoming validated in a ten,000-topic clinical trial, Cancer Origin Epigenetics – Harbinger Wellness (CORE-HH, NCT05435066), in conjunction with the Sarah Cannon Study Institute. Presently on target to total enrollment by year finish, the CORE-HH study is made to enroll a diverse and representative population with and with out cancer at up to 40 U.S. web pages.

About Harbinger Wellness

Harbinger Wellness is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis and management. The corporation combines advances in artificial intelligence with proprietary insights into the biology of the beginnings of cancer to recognize cancer ahead of it is visible or symptomatic with the aim of creating a low-expense, multi-cancer blood test. Harbinger envisions a future exactly where, as an alternative of maintaining cancer from spreading, it could be kept from forming, producing a cancer diagnosis a routine overall health difficulty to be addressed rather than a life-altering occasion to be feared with profound implications for people today, healthcare systems and societies. Harbinger was founded by Flagship Pioneering right after 3 years of foundational investigation in its Labs unit and launched in 2020. Understand additional about Harbinger by going to Harbinger-Wellness.com or following us on Twitter (@harbingerhlth) and LinkedIn.

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