Novel interventional study to progress multi-cancer, early-detection test into clinical practice
GRAIL (CA, USA) has announced the launch of a prospective, interventional study seeking to advance its multi-cancer, early-detection test into clinical practice.
The healthcare company GRAIL (CA, USA) has announced the launch of an interventional, multi-center study, entitled PATHFINDER, which ultimately aims to advance GRAIL’s multi-cancer, early-detection test into clinical practice.
It is well established that the earlier detection of cancer is associated with improved prognosis, treatment success and survival rates. However, there are no guideline-recommended screening procedures currently available for many of the deadliest cancers.
GRAIL’s multi-cancer, early-detection test employs methylation-based technology, which targets the most informative regions of the genome and uses its proprietary database and machine-learning algorithms to detect the presence and tissue-specific location of cancer.
Previous clinical trials have demonstrated that the test can successfully detect more than 50 cancer types across all stages via a single blood draw, with a false-positive rate of less than 1% percent.
The PATHFINDER study, which has been granted US FDA Investigational Device Exemption status, has begun participant enrollment and will represent the first time that results of GRAIL’s multi-cancer, early-detection test will be communicated to physicians and patients, to guide clinical and diagnostic decision making. The test, which seeks to complement, not replace, traditional screening procedure results such as of mammograms and colonoscopies, is able to provide a location of the cancer detected, which can be utilized by clinicians to progress a decision pathway to ultimate diagnostic resolution.
The trial aims to enroll a total of approximately 6200 participants, who will be followed for 12 months, across several health systems; initial partner health systems include the Dana-Farber Cancer Institute (MA, USA), Intermountain Healthcare (UT, USA), Mayo Clinic (MN, USA), Oregon Health & Science University (OR, USA) and Sutter Health (CA, USA).
Hans Bishop, CEO of GRAIL, commented: “GRAIL is at the forefront of transforming early cancer detection as we bring our multi-cancer test into clinical practice through our first interventional study. We are partnering with leading healthcare systems to gain important real-world insight into the clinical use of our multi-cancer early-detection test, an important step on our path toward commercialization.”