Round includes multiple global institutional investors including Flagship Pioneering, Pictet, Partners Investment, and M&G 

Financing will enable completion of clinical validation of Harbinger’s first blood-based cancer screening product, further evidence-generation activities and continued organization scale-up ahead of anticipated 2025 product launch

CAMBRIDGE, Mass., Sept. 28, 2023 /PRNewswire/ — Harbinger Health, a biotechnology company pioneering new technologies to fundamentally change cancer screening and detection, announced today that it raised $140 million in Series B funding. The financing round is comprised of the Company’s founder, Flagship Pioneering, alongside new global institutional investors including Pictet, Partners Investment, and Catalyst, M&G Investments’ purpose-led private assets strategy, among other investors. The new funds will be used to support the completion of Harbinger’s Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) 10,000-participant clinical study of its novel blood-based cancer screening platform; develop its two-tier testing model; expand its data science and commercial teams and capabilities; and initiate additional clinical studies in high-risk populations.

Harbinger is developing a proprietary two-tier testing model with the goal of making cancer screening accessible on a global scale. Harbinger’s product development strategy is designed to enable low-cost population testing to achieve broad affordability, improve Positive Predictive Value (PPV) to reduce the burden of false positives, and quantitative individual longitudinal monitoring to better guide clinical decision making if cancer is detected. Harbinger’s platform, HarbingerHx, leverages machine learning, proprietary insights into the molecular biology of cancer’s origins, and growing datasets to develop insights that maximize clinical informativeness.

The Company expects to launch its first product – a laboratory developed test (LDT) for the detection of early cancer – in 2025. The LDT, the HarbingerHx platform, and the Company’s proprietary DNA library archiving technology together will make it possible to rapidly launch additional products over time, addressing specific disease types and population groups.

“At Harbinger, our goal is to lead the way to a future where cancer screening is routine, affordable and accessible for everyone,” said Stephen Hahn, M.D., CEO of Harbinger Health. “We have a unique opportunity to make cancer screening tools work better and work for more people through our biological and technical solutions. We are achieving this by combining machine learning with insights into the biology of cancer’s origins and individual risk in order to provide actionable information to providers, enabling them to guide improved clinical decision making for their patients. This is where I see our greatest potential to reduce cancer mortality rates in our lifetimes.”

“Since its inception, Harbinger has built a platform that integrates our ability to understand the underlying biology of cancer with the ability to aggregate large datasets to fuel product development to solve some of the greatest challenges in the cancer screening field today,” said Douglas Cole, M.D., co-founder and chairman, Harbinger Health and managing partner, Flagship Pioneering. “This current financing will enable us to scale and advance a proprietary product model that optimizes for performance, accessibility, and cost and ultimately seeks to provide the right test for the right patient at the right time.”

Harbinger has raised approximately $190 million in total funding since its formation in 2020. This funding round comes on the heels of multiple business and clinical milestones for Harbinger as it continues the acceleration of its two-tier, multi-cancer platform, including multiple appointments to its executive leadership team and data presentations demonstrating the performance of Harbinger’s platform.

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 low-cost, multi-cancer blood tests. 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 www.harbinger-health.com or following us on Twitter (@harbingerhlth) and LinkedIn.

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SOURCE Harbinger Health