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Bio-Techne Nabs CE Mark for HPV Head and Neck Cancer Test, Completes Namocell Acquisition

NEW YORK – Bio-Techne said on Wednesday that it has recently received CE marking and launched in Europe its assay for human papillomavirus for use in patients with head and neck cancer.

The RNAscope ISH Probe High Risk HPV test is intended to qualitatively detect HPV in patients diagnosed with oropharyngeal squamous cell carcinoma. HPV is a "major cause" of the cancer and can be a "valuable diagnostic marker that significantly impacts clinical management," the Minneapolis-based firm said in a statement. 

The test directly detects E6/E7 mRNA from formalin-fixed paraffin-embedded tissue specimens and can be used to inform treatment selection in patients with head and neck cancer. RNAscope in situ hybridization as used in the HPV test allows users to visualize biomarker expression patterns by light microscopy, Bio-Techne said. The assay is intended for use in clinical laboratories with the Bond RNAscope Brown Detection kit on the Leica Biosystems Bond-III stainer. 

In a separate announcement, Bio-Techne said it has completed its acquisition of single-cell sorting and dispensing firm Namocell, which it announced last month. Namocell is expected to complement Bio-Techne's cell and gene therapy development, cell engineering, cell line development, single cell genomics, synthetic biology, rare cell isolation, and antibody discovery, Bio-Techne said.