Vigilant Biosciences, an early-stage Fort Lauderdale-based company that develops solutions that aid in the early detection and intervention of cancer, announced that it has CE Marked its OncAlert Oral Cancer RAPID Test, meaning it can market the product in the 28 countries of the European Union as well as Norway, Iceland, Liechtenstein and Switzerland.
The OncAlert RAPID Test is an easy-to-use oral rinse test to aid healthcare clinicians assessing potentially at-risk patients for oral cancer, a disease that brings more than 600,000 new cases each year worldwide. The company said 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 results can be read by the clinical professional within 20 minutes.
The venture-backed company said it has multiple distribution agreements secured throughout Europe and the Asia/Pacific region and it expects to begin shipping the product during the second half of this year. It is not available in the U.S., but is undergoing FDA regulatory approval processes. Vigilant has received nearly $8 million in funding, including from the Florida Institute for the Commercialization of Public Research.
Matthew H.J. Kim, founder, chairman and CEO of Vigilant Biosciences, called the CE Marking a major milestone because it enables the company to begin manufacturing and sales efforts. “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,” Kim said.