Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of oral/oropharyngeal cancer, today announced the launch and first patient enrollment for clinical studies of its OncAlert® point-of-care qualitative assay in support of its registration submission to the Food and Drug Administration (FDA).
Vigilant Biosciences’ initial FDA 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 for oral/oropharyngeal cancer. The study will enroll up to 1,000 patients with 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 Corporation, the parent organization for an extensive family of affiliated companies specializing in dental insurance and administration, technology, claims clearinghouse, and dental practice management services.
“We are very pleased to begin FDA studies to bring our groundbreaking OncAlert technology to the U.S.,” said Matthew H.J. Kim, Vigilant Biosciences Founder and Chief Executive Officer. “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 U.S.,” said Michael J. Donovan, Ph.D., M.D. Chief Clinical Officer of 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. The simple, oral rinse procedure is easy to administer and non-invasive for the patient. The OncAlert Oral Cancer product line, includes the OncAlert Oral Cancer RAPID Test and the OncAlert Oral Cancer LAB Test, both CE Marked and available in select markets outside the United States. Vigilant Biosciences’ accurate, cost-effective tests can benefit every adult, with particular emphasis on high-risk populations (i.e., current and former tobacco users, those who consume excessive alcohol, and people with human papillomavirus).