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.