Vigilant Biosciences, a leading innovator and developer of solutions that aid in the early detection and intervention of cancer, today announced that it has CE Marked its OncAlert Oral Cancer RAPID 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.
The OncAlert RAPID Test is an easy-to-use, accurate and cost-effective, qualitative tool to aid frontline healthcare clinicians assessing potentially at-risk patients for oral cancer. It is the first and only rapid 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 clinically shown to indicate early stage cancers to serve as an aid in diagnosis, along with other clinical factors.
The OncAlert RAPID Test comprises an oral rinse, which is expelled into a cup, and a test cassette containing a lateral flow test strip that is inserted into the sample of the expelled rinse. Within 20 minutes the test device is read by the healthcare professional.
The test takes seconds to administer and provides an easy-to-read colorimetric result indicating presence of CD44 and total protein with respect to pre-determined threshold levels for cutoffs in the specimen.
As previously announced, Vigilant Biosciences has multiple distribution agreements secured throughout Europe and Asia/Pacific with additional partnerships to be announced and expects to begin shipping the product during the latter half of 2016.
"CE Marking of our OncAlert RAPID Test is a major milestone for our Company as it enables us to initiate manufacturing and sales efforts across the international community," said Matthew H.J. Kim, Founder, Chairman, and CEO of Vigilant Biosciences, Inc.
"We have built, and will continue to build upon, a strong distribution network across the EU and other regions of the world, and we are looking forward to making an impact on the high rate of late-stage oral cancers diagnosed globally."
Vigilant Biosciences’ initial products, the 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 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.
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 and the OncAlert RAPID Test are CE Marked and available for sale in certain select international markets. The OncAlert Oral Cancer product line is not yet available for sale in the U.S.