Vigilant BioSciences, which develops solutions that aid in the early detection and intervention of cancer, announced Monday that it has CE Marked its OncAlert LAB Assay for oral cancer risk. CE Marking allows Vigilant Biosciences to market the product in the 28 countries of the European Union as well as Norway, Iceland, Liechtenstein and Switzerland.
The OncAlert LAB Assay is a noninvasive, accurate and cost-effective tool for clinicians involved in the diagnosis and treatment of oral cancer. The test, an oral rinse, measures specific protein markers known to indicate risk of early stage cancers and aids in the diagnosis of oral cancer, along with other clinical factors.
The venture-backed Fort Lauderdale-based company has multiple distribution agreements secured across the EU and expects to begin shipping the product during the first quarter of 2016.
CEO Matthew H.J. Kim, who was recently named Entrepreneur of the Year by BioFlorida, called the approval a “major milestone” for the company. “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.”