Flagship Pioneering Launches Harbinger Health to Detect Early Cancer with a Simple, Bio-AI Based Blood Test

Dr. Stephen Hahn, former FDA Commissioner and Chief Medical Executive for MD Anderson Cancer Center, becomes CEO

Following three years of research and development, Flagship unveils Harbinger Health with $50 million of committed capital

CAMBRIDGE, Mass., December 7, 2021 -- Flagship Pioneering today announced the launch of Harbinger Health, a bioplatform company pioneering the detection of early cancer with a simple blood test that combines Artificial Intelligence (AI) and Machine Learning advances with its recent discoveries about the biology of early cancer. By using this Bio-AI approach to identify cancer before it is visible or symptomatic, Harbinger Health’s proprietary HarbingerHx^TM platform has the potential to create an entirely new paradigm for cancer diagnosis, enabling early therapeutic interventions or prevention. Stephen Hahn, M.D., the 24^th Commissioner of the United States Food & Drug Administration, and former Chief Medical Executive of MD Anderson Cancer Center will lead the company as CEO of Harbinger Health. Dr. Hahn, who joined Flagship earlier this year as Chief Medical Officer of the company’s Preemptive Medicine and Health Security Initiative, will now become a Flagship CEO-Partner as well as CEO of Harbinger. Flagship’s initial commitment to Harbinger Health is $50 million.

“Harbinger Health has the potential to revolutionize the way we detect, diagnose, and treat cancer, enabling interventions at a much earlier phase of the disease than is currently possible,” said Doug Cole, M.D., Co-Founder and Chairman, Harbinger Health and Managing Partner, Flagship Pioneering. “Unlike prior approaches that are purely statistical in nature, Harbinger’s approach is informed by its insights into specific biological events that take place early in the development of cancer. After three years of research and development within Flagship Labs, we have created a platform that harnesses these insights to enable high-resolution, blood-based assays. With Harbinger Health, we have the potential to intervene in the cancer continuum far earlier than ever before, thus increasing the opportunities to save more lives.”

Flagship Founder and CEO Noubar Afeyan, Ph.D., added, “Steve Hahn has been instrumental in Flagship’s Preemptive Medicine and Health Security Initiative, which is creating a new field that aims to protect, maintain, or improve people’s health before they get sick. Leading Harbinger Health is the natural evolution of that work. I’m thrilled that Steve, a recognized oncologist and leader in medical research, as well as a former FDA commissioner, has joined as CEO-Partner to lead the launch of Harbinger Health.”

“Harbinger Health is poised to redefine our approach to oncology, moving beyond cancer ‘staging,’ and toward early detection that enables the diagnosis and treatment of cancer and ultimately to effectively reduce morbidity and mortality associated with the disease,” said Stephen Hahn, M.D., CEO, Harbinger Health and CEO-Partner, Flagship Pioneering. “We are committed to developing our platform so there is access to early cancer detection for all individuals with a simple test. No one should be disadvantaged in the fight against cancer – it’s our goal to bring the power of this platform not only to those with access to the top cancer centers – but to everyone.”

About Dr. Stephen Hahn

Dr. Stephen Hahn joined Flagship Pioneering as Chief Medical Officer of its Preemptive Medicine and Health Security Initiative in June 2021. Prior to joining Flagship, Dr. Hahn served as the 24th Commissioner of the U.S. Food and Drug Administration, where he led the 17,000+ person agency that regulates approximately 20 percent of consumer spending in the United States.

Dr. Hahn, an internationally respected oncologist, served as chief medical executive at the world-renowned MD Anderson Cancer Center in Houston prior to his FDA appointment. Prior to his role as chief medical executive, he served as deputy president and chief operating officer. In that role, he was responsible for the day-to-day operations of the nation’s top cancer center, which included leading more than 21,000 employees and overseeing a $5.2 billion operating budget. He was elevated to the chief operating officer role after serving as division head, department chair, and professor of Radiation Oncology. Prior to his executive leadership roles at MD Anderson, Dr. Hahn was the leader of radiation oncology at the University of Pennsylvania’s Perelman School of Medicine.

A 1980 Rice University graduate, Dr. Hahn grew up in the Philadelphia area. He earned his medical degree at Temple University and was an internal medicine resident at the University of California San Francisco before completing a fellowship and residency at the National Cancer Institute in Bethesda, Maryland. He joined the University of Pennsylvania Perelman School of Medicine as an assistant professor in 1996 and rose to chair its radiation oncology department from 2005.

About Flagship Pioneering

Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics (Nasdaq: FHTX), Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics (Nasdaq: SGTX).

About Harbinger Health

Harbinger Health is transforming the detection, diagnosis, and treatment of cancer for everyone. Founded in Flagship Labs in 2018, the company harnesses unique, proprietary insights into the biology of cancer, augmented with Artificial Intelligence and Machine Learning, to enable high-resolution blood-based assays. By identifying cancer before it is visible, Harbinger Health’s platform has the potential to create an entirely new pathway for cancer diagnosis, enabling early therapeutic interventions. www.Harbinger-Health.com.