Vigilant Biosciences Receives CE Mark for OncAlert® Oral Cancer LAB Test to Aid in Diagnosis of Oral Cancer
November 16, 2015
FORT LAUDERDALE, Fla. – November 16, 2015 – 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 LAB Test (“OncAlert LAB Test”). 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.
Vigilant Biosciences’ OncAlert LAB Test 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 and stem cell associated 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 second quarter of 2016.
“CE Marking of our OncAlert LAB Test 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 Test is one of two products comprising Vigilant Biosciences’ OncAlert Oral Cancer product line, which also includes the OncAlert Oral Cancer RAPID Test (“OncAlert RAPID Test”). The OncAlert LAB Test and the OncAlert RAPID 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 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 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 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 www.vigilantbiosciences.com.