Vigilant Biosciences Announces Publication of Research on Risk Stratification System for Oral Cancer Screening

March 31, 2016

Vigilant Biosciences, Inc. (“Vigilant”), a leading innovator and developer of solutions that aid in the early detection and intervention of cancer, today announced that Cancer Prevention Research, a peer-reviewed medical journal of the American Association for Cancer Research, published an article on clinical research establishing proof-of-concept for the technology licensed and now under commercial development as part of the Company’s OncAlert® Oral Cancer product line.

The paper, entitled “Risk Stratification System for Oral Cancer Screening,” reported the results of a study that demonstrated the association of salivary CD44 and total protein levels with oral cavity and oropharyngeal cancer. The research also demonstrated that a simple, inexpensive and noninvasive tool may help identify individuals who are developing oral cancer at a stage when the process can be easily treated or reversed. The study was conducted by principal investigator Elizabeth Franzmann, M.D., a member of Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and Director of Head and Neck Research and Associate Professor at the Miller School of Medicine Department of Otolaryngology, who is also the scientific founder and Chief Scientific Officer for Vigilant Biosciences.

Cancer Prevention Research is devoted exclusively to cancer prevention. The journal publishes important original studies, reviews, and perspectives within the major topic areas of biology of premalignancy, risk factors and risk assessment, early detection research, immunoprevention, and chemopreventive and other interventions, including the basic science behind them. Cancer Prevention Research comprises preclinical, clinical and translational research, with special attention given to molecular discoveries and an emphasis on building a translational bridge between the basic and clinical sciences. The article was published online on March 28, 2016, and will appear in an upcoming print issue of Cancer Prevention Research.

About the OncAlert Oral Cancer Product Line
Vigilant Biosciences’ initial products, the OncAlert Oral Cancer RAPID Test (“OncAlert RAPID Test”) and the OncAlert Oral Cancer LAB Test (“OncAlert LAB Test”), are the first and only technologies that measure soluble CD44 and total protein levels – protein markers clinically shown to be associated specifically with oral cancer when measured in an oral rinse – to aid clinicians in the early detection and intervention of oral cancer. Both products use a simple, oral rinse collection and measurement procedure that is easy to administer and non-invasive for the patient. The 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, HPV-16). The OncAlert LAB Test is CE Marked. The OncAlert RAPID Test is currently undergoing the CE Mark registration process and not yet available for sale in any market at this time. The OncAlert Oral Cancer product line is not yet available for sale in the U.S.

About Oral Cancer
According to the Oral Cancer Foundation, there are over 600,000 new cases of oral cancer each year worldwide. In the U.S., close to 48,330 individuals will be diagnosed with oral or pharyngeal cancer this year, with 9,570 deaths from the disease, killing roughly one person per hour, 24 hours per day. Historically the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. Currently, the vast majority of patients are detected through a visual exam and/or are symptomatic, at which point they are likely late stage. As a result, oral cancer often goes undetected to the point of metastasizing. Early diagnosis of oral cancer results in a cure rate of up to 90 percent.

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. Vigilant’s OncAlert Oral Cancer product line includes rapid and lab-based products that are simple, accurate and cost-effective, and empower healthcare practitioners to improve lives through earlier intervention. The OncAlert Oral Cancer product line is not yet available for sale in the U.S. For more information, visit

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