Vigilant Biosciences Inc, Fort Lauderdale, Fla, has launched patient enrollment for clinical studies of its OncAlert point-of-care qualitative assay in support of its premarket regulatory submission to FDA.
Vigilant Biosciences’ initial clinical study is designed to validate performance and evaluate implementation of the OncAlert rapid point-of-care qualitative assay into the standard-of-care paradigm for patients presenting with increased clinical risk of oral or oropharyngeal cancer. The study will enroll up to 1,000 patients at sites located in the United States as well as internationally.
Part of the funding support Vigilant Biosciences will receive for the study will come from Renaissance Health Service Corp, the parent organization for an extensive family of affiliated companies specializing in dentistry practice management services, including administration, an insurance claims clearinghouse, and related technologies.
“We are very pleased to begin FDA studies to bring our groundbreaking OncAlert technology to the United States,” says Matthew H.J. Kim, founder and CEO of Vigilant Biosciences. “Oral cancer is a growing global issue, and we are seeing a great need for our solutions around the world. We are very encouraged by the success of the product to date, and look forward to continuing to deliver breakthrough solutions to aid clinicians in the early detection and intervention of oral cancer.”
“Our commencement of patient enrollment in our FDA study is an important milestone in bringing our OncAlert technology to the United States,” says Michael J. Donovan, PhD, MD, chief clinical officer at Vigilant Biosciences. “We believe that the OncAlert technology will enhance our capability to detect oral and oropharyngeal cancer earlier than current standard-of-care approaches. We look forward to these initial clinical study results and moving towards FDA clearance of the test.”
The Vigilant Biosciences OncAlert Oral Cancer product line is based on patented technology that measures soluble CD44, a tumor-initiating and stem cell–associated biomarker, and total protein levels—markers clinically validated to be associated specifically with oral cancer—to aid clinicians in the early detection and intervention of oral cancer.
For more information, visit Vigilant Biosciences.