The CE mark, a mandatory conformity marking in the European Union (EU), will allow the product to be sold in the 28 countries of the EU and Norway, Iceland, Liechtenstein and Switzerland.
Vigilant Biosciences Inc. has 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 health-care 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 health-care 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 predetermined 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.”