NEW YORK – Harbinger Health and the Sarah Cannon Research Institute (SCRI) on Wednesday announced the launch of a clinical trial to validate Harbinger's blood-based early cancer detection test.
The study, dubbed CORE-HH, will enroll roughly 10,000 participants at up to 40 sites in the US. The study will have two cohorts: one for patients with cancer and the other for healthy adults. Patients without cancer will be followed for up to two years.
Harbinger is hoping the trial will yield insights that will help it improve its test's ability to detect multiple cancers in early stages and determine a cancer's location. The Cambridge, Massachusetts-based firm expects to begin reporting data from the trial next year.
For its part in the collaboration, SCRI is conducting the study through its contract research organization and has already started enrolling patients at sites affiliated with its parent company, HCA Healthcare.
Harbinger, which launched out of the life sciences venture capital firm Flagship Pioneering in 2020 and boasts former US Food and Drug Administration Commissioner Stephen Hahn as its CEO, is using a combination of machine learning and biology to inform what it hopes will be a low-cost, multi-cancer blood test. According to the firm, data from the CORE-HH clinical trial will further guide its development strategy for the test.