Vigilant Biosciences, a startup company in Fort Lauderdale, has received European Commission approval to market its oral cancer testing product.
European approval to sell the product “is a major milestone for our company as it enables us to initiate manufacturing and sales efforts across the international community,” said Matthew Kim, founder and CEO of Vigilant Biosciences.
The European “CE Marking,” which signifies a product meets standards of safety, health and environmental protection requirements, allows Vigilant to market the product in the 28 countries of the European Union as well as Norway, Iceland, Liechtenstein and Switzerland.
In late 2015, Vigilant received European approval for its lab test for oral cancer detection.
The company’s OncAlert Rapid test is a tool for dentists and other health care clinicians to assess patients’ risk for oral cancer, measuring specific protein markets clinically shown to indicate early stage cancers.
The test is an oral rinse. After the patient expels into a cup, a test strip is inserted into the sample to detect biomarkers for head and neck cancer. The test can be read by the health care professional within 20 minutes.
While the OncAlert Rapid test can stand on its own, positive results also may be followed up by a lab test or biopsy, according to Vigilant’s spokeswoman.
Vigilant Biosciences already has secured distribution agreements in Europe and the Asia/Pacific region and expects to begin shipping its product during the latter half of 2016.
Kim founded Vigilant in 2011 to develop the early detection test, inspired by his family history of oral and other cancers. His father died last March at age 79 after surviving with the disease for many years; his mother is a five-year survivor.
The entrepreneur has said he hopes to be able to offer its early detection test in the U.S. by 2017.
Kim founded the company after discovering the 15 years of research and clinical studies for an oral cancer test by Dr. Elizabeth Franzmann, a University of Miami faculty member. Franzmann is now Vigilant’s chief science officer.
Currently, the majority of patients with oral cancer are detected through a visual exam or symptoms, which often means they’re late stage. More than 48,000 individuals in the United States alone will be diagnosed with oral or oropharyngeal cancer this year, with close to 9,600 deaths resulting from this disease, according to The Oral Cancer Foundation.
Early diagnosis of oral cancer results in a cure rate of up to 90 percent, industry experts say.
Vigilant opened a new headquarters in Fort Lauderdale in late 2015. Also last year, Kim was recognized by BioFlorida, the state’s biotech organization, with its Weaver H. Gaines Entrepreneur of the Year Award.
Investors have taken notice as well.
During the first quarter, Vigilant received $3.25 million from an undisclosed investor, according to the MoneyTree report by PricewaterhouseCoopers LLP and the National Venture Capital Association.