Company begins drive toward FDA clearance of first and only test to detect a tumor-initiating stem cell-associated biomarker for oral and oropharyngeal cancer
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).
About Oral Cancer
According to the World Health Organization, there are more than 529,000 new cases of oral (lip, oral cavity and pharynx) cancer each year worldwide, with mortality rates that reach up to 292,000 deaths each year. In the United States, more than 49,750 individuals will be diagnosed with oral cancer this year – around 132 new cases of oral cancer diagnosed each day. More than 9,750 people will die in the U.S. this year, as a result of the disease. Historically, the death rate associated with oral cancer is particularly high due to late stage diagnosis and intervention.
Currently, the vast majority of patients are detected through a visual and physical exam when symptomatic and are likely late stage. As a result, oral cancer often goes undetected to the point of metastasizing. More than 40 percent of those diagnosed with oral cancer die within five years, due to late stage diagnosis. In contrast, early detection (stage I and II) of oral cancer yields survival rates of up to 90 percent. For those who survive oral cancer diagnosed in the later stages, the treatment is painful, debilitating and often disfiguring. In addition, patients often struggle with eating and drinking, communicating and self-image.
About Renaissance Health Service Corporation
Renaissance Health Service Corporation is the parent organization for an extensive family of affiliated companies specializing in dental insurance and administration, technology, claims clearinghouse, and dental practice management services. Renaissance Health Service Corporation companies collectively are among the largest administrators of dental benefits plans in the United States, providing coverage for 12.8 million people and paying more than $3.7 billion for dental treatment in 2016. With its oldest organization founded in 1957, the affiliated companies today maintain offices in Arkansas, Indiana, Kentucky, Michigan, New Mexico, New York, North Carolina, Ohio and Tennessee in the United States, while international operations are headquartered in Copenhagen, Denmark.
About Vigilant Biosciences, Inc.
Vigilant Biosciences is a leading innovator and developer of solutions that aid clinicians in the early detection and intervention of cancer. The Vigilant Biosciences OncAlert® Oral Cancer product line and OncAlert Labs product line include point-of-care and lab-based products and services that are simple, accurate and cost-effective and that can empower healthcare practitioners to improve potential outcomes through earlier intervention. The OncAlert Oral Cancer LAB Test and the OncAlert Oral Cancer RAPID Test are CE Marked and available in select international markets outside the U.S. The OraMarkTM Test is a Laboratory Developed Test that is only available in the U.S. exclusively through OncAlert Labs, LLC, a CLIA-certified laboratory and a member of the Vigilant Biosciences family of companies. For more information, visit www.vigilantbiosciences.com and www.oncalertlabs.com.