Cancer Detection Tool Earns CE Mark



The OncAlert Oral Cancer CD44/Total Protein LAB Test from Vigilant Biosciences now has the CE Mark, which means it has been approved for distribution and marketing in the 28 countries of the European Union (EU) as well as in Norway, Iceland, Liechtenstein, and Switzerland.

Also known as the OncAlert Lab Assay, the detection tool measures soluble CD44 and total protein levels. These specific markers are known to indicate early stage cancers and help practitioners diagnose oral cancer along with other clinical factors.

The OncAlert Lab Assay and the OncAlert Oral Cancer Rapid Point-of-Care Test comprise the company’s OncAlert Oral Cancer System. Both use a simple oral rinse that patients swish for 5 seconds and spit into a cup. Practitioners can administer them during any routine checkup.

Vigilant Biosciences already has multiple distribution agreements across the EU, including 3 recent multiyear deals for sales and marketing in the Czech Republic and Slovakia, Israel, and the Baltic region. The company expects distribution to begin in the first quarter of 2016.

“Through these partnerships, we will be able to provide simple, accurate, and cost-effective solutions as an aid in the diagnosis of oral cancer in patients, which will result in earlier detection and intervention,” said Matthew H. J. Kim, founder, chair, and CEO of Vigilant Biosciences.

The company also has selected Cardinal Health as the third-party logistic provider for the OncAlert Oral Cancer System. Cardinal will oversee the execution, monitoring, and reporting of Vigilant’s supply-chain logistic in the United States and international markets.

“Our company is poised for rapid growth over the next 24 months, with the launch of our OncAlert Oral Cancer System in international and domestic markets, and Cardinal Health is the right partner to help us support that growth while ensuring the best possible experience for our customers,” Kim said.

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