Vigilant Biosciences has received the European Conformity (CE) mark for its OncAlert Oral Cancer RAPID Test, enabling the company to market the product in the 28 countries of the European Union (EU) as well as in Norway, Iceland, Liechtenstein, and Switzerland.
Worldwide, more than 600,000 people are diagnosed with oral cancer each year, with 360,000 deaths. The death rate is so high because it typically isn’t diagnosed until Stage III or IV. Most patients are now identified through a visual exam or when they are symptomatic. Patients who are diagnosed earlier, though, see a cure rate of up to 90%.
The test measures soluble CD44 and total protein levels, which are clinically shown to indicate early stage cancers and serve as an aid in diagnosis, along with other clinical factors. It comprises a noninvasive oral rinse expelled into a cup and a test cassette containing a lateral flow test strip that’s inserted into the sample of the expelled rinse.
Within 20 minutes, healthcare professionals can read the colorimetric results indicating the presence of CD44 and total protein with respect to predetermined threshold levels for cutoffs in the specimen. Studies have shown specificity as high as 95% and sensitivity of about 88%.
“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, chair, and CEO of Vigilant Biosciences.
“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.
Vigilant Biosciences has multiple distribution agreements secured throughout Europe and the Asia-Pacific region and expects to begin shipping the OncAlert Oral Cancer RAPID Test during the latter half of 2016.
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