Skip to main content

RNAscopeTM ISH Probe High Risk HPV Assay Available for Clinical Use in Europe on the Fully Automated BOND-III Stainer from Leica Biosystems

Probes for the CE-IVD marked kit now available for clinical use. 

Leica Biosystems, a global leader in pathology workflow solutions, previously partnered with Bio-Techne to create a fully automated, walk-away solution on the BOND-III IHC and ISH stainer, for use in automating RNA ISH. Now, Bio-Techne has registered probes for clinical utility within Europe for use with the RNAscope detection kit from Leica Biosystems. The CE-IVD marked RNAscope ISH Probe High Risk HPV is intended for use in patients diagnosed with oropharyngeal squamous cell carcinoma (OPSCC) to aid in the identification of high-risk human papillomavirus (HPV).

RNAscope in situ hybridization is a highly sensitive and specific spatial biology technology that enables users to visualize and localize biomarker expression patterns by light microscopy. On the BOND-III Advanced Staining solution from Leica Biosystems, precise automation ensures reduced process variation and uniform staining consistency.

“We are excited to see the RNAscope ISH Probe High Risk HPV receive the CE-IVD mark,” said Colin White, Senior Vice President of Advanced Staining and Imaging at Leica Biosystems. “This broadens the application of the solution to the clinical sphere, which supports our mission of Advancing Cancer Diagnostics, Improving Lives.”

RNAscope ISH Probe High Risk HPV is used in an RNAscope ISH assay for the qualitative detection of HPV E6/E7 mRNA in formalin-fixed, paraffin embedded (FFPE) tissue specimens. RNAscope ISH Probe High Risk HPV is for use in clinical laboratories with the CE-IVD marked BOND RNAscope Brown Detection kit on the automated BOND-III stainer from Leica Biosystems. The assay detects high-risk HPV types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82.

This solution may not be available in all geographies. Contact your Leica Biosystems sales representative for more information. 


About Leica Biosystems
Leica Biosystems is a cancer diagnostics company and a global leader in workflow solutions. Only Leica Biosystems offers the most comprehensive portfolio that spans the entire workflow from biopsy to diagnosis. With unique expertise, we are dedicated to driving innovations that connect people across radiology, pathology, surgery and oncology. Our experts are committed to delivering Improved Quality, Integrated Solutions, and Optimized Efficiencies leading to breakthrough advances in diagnostic confidence. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Visit for more information.