Harbinger Health

About Harbinger Health

Harbinger Health operates at the forefront of biotechnology, focusing on the early detection of cancer. The company was founded in 2018 within Flagship Pioneering's labs, previously known as Flagship Labs 67, and officially launched in 2021 with an initial commitment of $50 million. Its headquarters are in Cambridge, Massachusetts. The company was co-founded by Doug Cole, M.D., Managing Partner at Flagship Pioneering, and scientists Kieran Chacko and Tony Shuber. In August 2025, Ajit Singh, Ph.D., a veteran of the diagnostics industry and an Adjunct Professor at Stanford's School of Medicine, was appointed CEO. He succeeded Stephen Hahn, M.D., the 24th Commissioner of the U.S. Food and Drug Administration, who led the company from its launch and now serves as CEO Emeritus. Dr. Hahn brought extensive experience from his time at the FDA and as chief medical executive at the MD Anderson Cancer Center.

Harbinger's core business revolves around developing affordable and accessible blood-based tests to detect cancer before a person shows symptoms. The company's proprietary platform, HarbingerHx™, combines insights into the biology of cancer's origins with artificial intelligence and machine learning. This technology analyzes epigenetic changes in cell-free DNA (cfDNA) from a blood sample to find biological markers that signal the very beginning of cancer development. This approach differs from purely statistical or genetic-focused methods by targeting specific biological events common to the early stages of most cancers. Revenue will likely be generated from its testing services, starting with a laboratory developed test (LDT). The company aims to make cancer screening a routine and low-cost part of healthcare, serving individuals, healthcare providers, and at-risk populations.

The company's primary product is a multi-cancer early detection (MCED) blood test. A key feature is a proprietary two-tier testing model designed to achieve broad accessibility and reduce false positives. This system aims to offer low-cost population screening paired with more advanced analysis to confirm findings and guide clinical decisions. In late 2023, Harbinger raised $140 million in a Series B funding round, bringing its total funding to approximately $190 million, to support the completion of a 10,000-participant clinical study (CORE-HH) and prepare for commercialization. Harbinger expects to launch its first LDT product in 2025, with its DNA library archiving technology enabling the rapid development of subsequent tests for specific diseases and populations.