Vigilant Biosciences (“VigilantBIO”) is a privately held medical technology company based in Norcross, Georgia focused on improving healthcare products to improve patient care. Their most recent research efforts center on early oral cancer detection.
In the United States, approximately 37,000 people will be diagnosed with oral cancer this year and its most common risk factor is exposure to the human papillomavirus (HPV). Nearly 40 percent of oral cancer patients will die within five years of diagnosis.
The high mortality rate for oral cancer is due to late discovery of the malignancy. In its early stages, the disease can either present no symptoms or the symptoms are often mistaken for other conditions.
VigilantBIO is currently trialing an easy-to-use, low-cost and noninvasive oral cancer screening product which tests the saliva (a very desirable biofluid). The patient and practitioners (e.g. dentists, hygienists, periodontists) benefit from the simplicity of the test – no venipuncture means higher test participation and no specialized staff is required to perform the test. In the oral clinical setting, this is ideal because it does not interfere with chair turnover ratio. In addition, test results can be delivered at the point of care.
When oral cancer is detected early, patients experience an 80-90 percent survival rate. Combined with the lowered treatment cost (an estimated 36 percent) and easy-to-implement product for oral care practitioners, the early detection product appears to be a winner for all involved.
With two clinical trials in process at the University of Miami, the sensitivity and specificity of the VigilantBIO salivary oral cancer biomarkers in detection of pre-cancerous cells are comparative to that of the Pap smear, which is considered the “gold standard” in HPV detection. The sensitivity factor falls within the 62-79 percent range for the VigilantBIO biomarkers compared with the 61-72 percent range for the Pap smear. Specificity is in the 88-100 percent range for the VigilantBIO oral cancer test compared with 82-94 percent for the Pap smear.
VigilantBIO has an exclusive license on the intellectual property from the University of Miami and the U.S. Patent Office issued a Notice of Allowance in October 2011 for key claims related to the technology. Additional patent applications are pending.
VigilantBIO will be presenting its products and technologies at OneMedForum SF 2012, on January 9 – 12.