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Home » Bio-Techne Gets CE-IVD Mark for Its Oropharyngeal Cancer HPV Detection Device
Bio-Techne Gets CE-IVD Mark for Its Oropharyngeal Cancer HPV Detection Device
Bio-Techne has received a CE-IVD mark for its RNAscope human papillomavirus (HPV) assay for use in detecting HPV in patients with oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer.
HPV, which is a major cause of the cancer, is “a valuable diagnostic marker that significantly impacts clinical management,” the Minneapolis, Minn.-based company said.
The RNAScope is an RNA in situ hybridization (ISH) system that allows visualization of single RNA molecules in a variety of tissue sample types, allowing users to visualize the HPV biomarkers.
With the CE-IVD mark in hand, the company plans on launching the device in Europe for use in clinical laboratories.
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