MIAMI – A new “rinse and spit” test for oral cancer is capable of early detection of tumors across “a racially and ethnically diverse population,” according to results of a study conducted by the University of Miami Miller School of Medicine.
Coinciding with Oral Cancer Awareness month, results from the largest oral cancer marker study of its kind in the US were presented at the annual meeting of the American Association for Cancer Research in Washington, D.C. and the American Head and Neck Society annual meeting in Orlando, Fla.
The test developed at the University of Miami Miller School of Medicine and exclusively licensed to Vigilant Biosciences, Inc., will be available as a low-cost, point-of-care “rinse and spit” screening test for the early detection of oral cancer.
The study of 300 subjects, sponsored by the National Cancer Institute, employed a case- control design ensuring cases (oral cancer patients) and controls (volunteers without cancer) were similar with respect to other important factors such as tobacco and alcohol use, age and race. The study was conducted by principal investigator Elizabeth Franzmann, MD, Associate Professor of Otolaryngology at the University of Miami Miller School of Medicine and a member of the University’s Sylvester Comprehensive Cancer Center.
“There is a tremendous need for a simple and painless test for early detection of oral cancer because the majority of patients present in late stage when cure rates reach only 40%,” said Dr. Franzmann. “Since minority patients and those of low socioeconomic status suffer disproportionately from this disease, results of the study show that an easy to administer, noninvasive and inexpensive test can provide patients with limited access to care ready means to early intervention and screening.”
“We are building on the leading work of Dr. Franzmann and her colleagues to develop a low-cost, specific and easy-to-use test that enables early detection and reliably rules out cancer,” said Vigilant founder and Chairman Matthew H.J. Kim, JD. “Vigilant’s product will be part of annual routine dental exams and will play an essential role in mass screening initiatives.”
Vigilant’s product, which is under development, consists of a low-cost, oral cancer-specific oral rinse test strip that provides an immediate and simple color change in the presence of certain levels of proteins clinically proven to be associated with early-onset of oral cancer – typically before a lesion is visually detected with a screening aid. Dental offices and public health screening facilities are seen as primary initial markets for the technology. The test can be applied to everyone, with particular emphasis on tobacco users, people who consume alcohol and people with human papillomavirus (HPV), and initially represents an approximately $600 million US market opportunity and a multibillion dollar opportunity worldwide.
About 42,000 new cases in the US and 640,000 people worldwide are diagnosed with oral cancer each year with more than half of those patients dying from the disease within 5 years of diagnosis due to late-stage diagnosis and intervention. Oral cancer treatment options include surgery, radiation and chemotherapy.