US-based medical technology company Vigilant Biosciences has secured CE mark approval for their OncAlert oral cancer RAPID test (OncAlert RAPID Test) to detect a tumour-initiating and stem cell associated biomarker for head and neck cancer.
With the CE mark, the test will now be introduced in 28 countries of the European Union (EU) as well as Norway, Iceland, Liechtenstein and Switzerland.
Vigilant Biosciences chairman CEO and founder Matthew Kim said: "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.
"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."
The OncAlert RAPID Test is an easy-to-use, accurate and cost-effective, qualitative tool to assist the frontline healthcare clinicians assessing the possibility of oral cancer in patients.
Claimed to be the first and only rapid test, it detects a tumour-initiating and stem cell associated biomarker for head and neck cancer.
The test measures soluble CD44 and total protein levels, specific protein markers clinically shown to indicate early stage cancers to serve as an aid in diagnosis, along with other clinical factors.
The OncAlert RAPID Test involves an oral rinse, ejected into a cup which is tested by inserting a test cassette containing a lateral flow test strip.
The test device, claimed to generate a reading within 20 minutes, is said to take seconds to administer and provides an easy-to-read colorimetric result.
Image: Histopathologic image of squamous cell carcinoma in oral cancer. Photo: courtesy of KGH.