Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of cancer, today announced that it has received a Phase I Small Business Innovation Research (SBIR) grant in the amount of US $219,454 from the National Institute of Dental and Craniofacial Research (NIDCR). The 15-month grant will fund research by Vigilant Biosciences to develop a diagnostic test that utilizes optical imaging in combination with an oral rinse to detect CD44, a tumor-initiating and stem cell-associated biomarker for oral cancer.
Vigilant Biosciences’ current product line is based on patented technology that measures an unprecedented combination of CD44 and total protein levels – markers clinically validated 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. The simple, oral rinse procedure is easy to administer and non-invasive for the patient. Vigilant Biosciences’ product line currently includes the OncAlert Labs OraMark™ Test, a laboratory developed test available only through OncAlert Labs, a CLIA certified laboratory; and 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.
“We are very pleased to receive this Phase I SBIR award from the NIDCR, as it supports the significance and further validation of the promise of our technology and its potential impact on cancer detection and intervention,” said Matthew H.J. Kim, Founder, Chairman, and CEO of Vigilant Biosciences. “The proprietary science behind our tests uses unique biomarkers that can indicate the presence of oral and oropharyngeal cancer, often before physical symptoms are present. This grant will enable us to expand our approach to additional platforms and applications to meet the critical and growing need for earlier intervention of this disease and potentially other cancers.”
The Phase I preclinical study will include in vitro work as well as human tissues from cancer patients and patients with benign disease of the throat.
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 reach up to 292,000 deaths each year. In the United States, more than 48,330 individuals will be diagnosed with oral cancer this year with close to 9,570 deaths resulting from this 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. 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 OraMark Test is a Laboratory Developed Test (LDT) 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.