Harbinger Health and Sarah Cannon Research Institute Launch Clinical Study to Validate and Advance Development of Harbinger’s Novel Early Cancer Detection Platform

Cambridge, MA & Nashville, TN– June 29, 2022. Harbinger Health, a biotechnology company pioneering the detection of early cancer, and Sarah Cannon Research Institute (SCRI) announced today the initiation of a 10,000-participant clinical study designed to validate and further develop Harbinger’s novel platform technology for blood-based early cancer detection.

The Cancer ORigin Epigenetics- Harbinger Health (CORE-HH) study plans to enroll a diverse and representative population with and without cancer at up to 40 sites across the U.S. The study is being run by SCRI’s contract research organization and has begun enrollment at sites affiliated with HCA Healthcare, SCRI’s parent company.

The primary objectives of the case-control study are to further develop and validate the diagnostic accuracy of Harbinger’s platform technology for the detection of early-stage cancer across multiple cancer types and to assess the ability to determine tumor location. The study, which is expected to read out in stages through 2023, is designed to advance Harbinger’s product development strategy.

“We are pleased to work with SCRI, a leading clinical research organization conducting community-based clinical trials, as we drive toward Harbinger’s goal of enabling the detection of cancer at the earliest points of disease, well before current means of screening could find it and when it’s possible to intervene with the greatest possibilities of success,” said Stephen Hahn, MD, CEO of Harbinger Health. “We share a vision of a world where nearly all cancers can be identified before they are symptomatic or even visible with simple, highly accurate and reliable blood tests that are widely accessible, particularly to those who have traditionally been underserved in our healthcare system.”

“Improving the ability to detect more cancers at earlier stages is important,” said Howard A. “Skip” Burris III, MD, FACP, FACSO, President & Chief Medical Officer, SCRI. “Blood-based testing has emerged in recent years as a potential way to address this important need, and we are excited to partner with Harbinger Health to develop testing capabilities that should improve outcomes for cancer patients through earlier diagnosis.”

More information on the CORE-HH study is available on www.clinicaltrials.gov using the identifier NCT05435066.

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 a low-cost, multi-cancer blood test. 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.

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is the research arm of HCA Healthcare’s Cancer Institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. A leader in drug development, SCRI has led more than 600 first-in-human clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies for more than a decade. Additionally, SCRI offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations.