Vigilant Biosciences has launched 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). The clinical studies are designed to validate the performance and evaluate the 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 and oropharyngeal cancer.
“We are very pleased to begin FDA studies to bring our groundbreaking OncAlert technology to the United States,” said 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.”
The 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 or oral cancer. These products are CE-Marked and available in select markets outside of the United States. The study will enroll up to 1,000 patients with domestic and international sites.
There are more than 529,000 new cases of oral cancer worldwide each year, reports the World Health Organization, with mortality rates reaching up to 292,000 deaths each year. More than 40% of those diagnosed die within 5 years because the disease typically isn’t diagnosed via a visual and physical exam until its later stages, when it already has metastasized. Plus, treatment during this time is painful, debilitating, and often disfiguring. However, cases diagnosed in stage 1 or 2 see survival rates of up to 90%.
According to Vigilant, dentists and dental hygienists can administer the OncAlert assay to patients who are at risk of oral cancer, such as those who use tobacco or alcohol or who may have the human papillomavirus. Patients simply swish its saline solution and spit it into a cup. The solution is then tested for CD44, which is detectable even when there are no visible signs of oral cancer. Dentists can direct patients whose results are positive to their physicians for more comprehensive testing, prompting early detection and better chances for survival.
“Our commencement of patient enrollment in our FDA study is an important milestone in bringing our OncAlert technology to the United States. We believe that the OncAlert technology will enhance our capability to detect oral and oropharyngeal cancer earlier than current standard of care approaches,” said Michael J. Donovan, PhD, MD, chief clinical officer of Vigilant Biosciences. “We look forward to these initial clinical study results and moving toward FDA clearance of the test.”