Vigilant BioSciences, an innovator and developer of 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. What that means: 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, aiding in the diagnosis of oral cancer, along with other clinical factors.
Vigilant Biosciences licensed technology from the University of Miami, and its creator, Dr. Elizabeth Franzmann (pictured above with CEO Matthew H.J. Kim), is a co-founder of the company. The venture-backed company has multiple distribution agreements secured across the EU and expects to begin shipping the product during the first quarter of 2016.
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," he said.