Vigilant Biosciences Receives CE Mark for OncAlert™ Oral Cancer CD44/Total Protein LAB Test to Aid in Diagnosis of Oral Cancer
First and Only Test to Detect a Tumor-initiating Stem Cell Biomarker for Head and Neck Cancer
FORT LAUDERDALE, Florida, Nov. 16, 2015 /PRNewswire/ -- Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of cancer, announced today that it has CE Marked its OncAlert™ Oral Cancer CD44/Total Protein LAB Test ("OncAlert LAB Assay"). CE Marking allows Vigilant Biosciences to market the product in the 28 countries of the European Union (EU) as well as Norway, Iceland, Liechtenstein and Switzerland.
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Vigilant Biosciences' OncAlert LAB Assay is a noninvasive, accurate and cost-effective, quantitative tool for clinicians involved in the diagnosis and treatment of oral cancer. It is the first and only test to detect a tumor-initiating stem cell biomarker for head and neck cancer. The test measures soluble CD44 and total protein levels – specific protein markers known to indicate early stage cancers – in an oral rinse, to serve as an aid in diagnosis of oral cancer, along with other clinical factors.
As previously announced, Vigilant Biosciences has multiple distribution agreements secured across the EU and expects to begin shipping the product during the first quarter of 2016.
"CE Marking of our OncAlert LAB Assay represents a significant achievement and major milestone for our Company, as it enables sales of the product in the EU and also serves as a gateway for other regions of the world," said Matthew H.J. Kim, Founder, Chairman, and CEO of Vigilant Biosciences, Inc. "With numerous distribution agreements in place and an aggressive marketing strategy, we are looking forward to making an impact on the high rate of late-stage oral cancers diagnosed globally."
The OncAlert LAB Assay is one of two products comprising Vigilant Biosciences' OncAlert™ Oral Cancer System, which includes the OncAlert™ Oral Cancer Rapid Point-of-Care Test ("OncAlert POC Test") and the OncAlert LAB Assay. Both products are based on patented technology that detects specific protein markers associated with oral cancer, even prior to the observation of visual or physical symptoms. The simple, oral rinse procedure is easy to administer and non-invasive for the patient. The test 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 Assay can be used together with or separately and independently from the OncAlert POC Test, which is currently under the CE Mark registration approval process. The OncAlert Oral Cancer System is not currently available for sale in the United States.
About Oral Cancer
According to the World Health Organization, there are over 600,000 new cases of head and neck cancer and 300,000 deaths each year worldwide. In the United States, more than 54,000 individuals were diagnosed with head and neck cancers in 2014, with 13,500 deaths from the disease. 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 company's point-of-care and lab-based tests that comprise its OncAlert™ Oral Cancer System provide noninvasive, accurate, and cost-effective tools designed to enable aiding early detection prior to visible symptoms. The OncAlert LAB Assay was CE registered in November 2015. The OncAlert POC Test is currently undergoing the CE Mark registration process and not yet available for sale in any market at this time. For more information, visit www.vigilantbiosciences.com.
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