June 29, 2022
Cambridge, MA and 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 artificial intelligence and machine learning advances 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 Harbinger Health (www.harbinger-health.com) or following us on Twitter (@HarbingerHlth) and LinkedIn.
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. In 2022, SCRI formed a joint venture with former US Oncology Research to enhance clinical trial access and availability across the country. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 600 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. The combined research network brings together physicians who are actively accruing patients to clinical trials at more than 290 locations in 26 states across the US. Please click here to earn more about our research offerings.