Former FDA Commissioner to Lead Start-up Company Developing Bio-AI Cancer Detection Test

By News Release


Flagship Pioneering launched Harbinger Health and also announced that Stephen Hahn, MD, the 24th Commissioner of the US FDA and former Chief Medical Executive of MD Anderson Cancer Center, will lead the company as CEO. Harbinger Health is 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. 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, MD, 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, PhD, added, "Steve Hahn has been instrumental in Flagship's Preemptive Medicine and Health Security Initiative, which is creating a new 􀀁eld 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, MD, 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."