Bio-Techne Announces Launch of the CE-IVD RNAscope™ ISH Probe High Risk HPV Assay for Head and Neck Cancer

Rhea-AI Summary

Bio-Techne (NASDAQ: TECH) has announced the European launch of the CE-IVD marked RNAscope ISH Probe High Risk HPV. This tool is designed for the accurate detection of HPV mRNA in patients with oropharyngeal squamous cell carcinoma (OPSCC). Compared to traditional methods like immunohistochemistry (IHC) for p16 protein, which can misdiagnose by 5-20%, the RNAscope ISH offers superior accuracy for identifying high-risk HPV types. This advancement allows clinicians to improve patient management and diagnosis.

Positive

• Launch of RNAscope ISH Probe High Risk HPV enhances diagnostic accuracy for HPV-related OPSCC.
• Eliminates misdiagnosis rates associated with p16 testing, providing a reliable diagnostic tool.

Negative

• None.

A highly accurate new tool for the direct detection of HPV mRNA in FFPE tissue specimens

MINNEAPOLIS, July 6, 2022 /PRNewswire/ -- Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities today announced the European launch of the CE-IVD marked RNAscope ISH Probe High Risk HPV, intended for use in patients diagnosed with oropharyngeal squamous cell carcinoma (OPSCC) to aid in the identification of high-risk human papillomavirus (HPV).

HPV is a major cause of OPSCC, and HPV has emerged as a valuable diagnostic marker that significantly impacts clinical management.^1,2 Immunohistochemistry (IHC) for p16 protein, a surrogate marker, is widely used for HPV detection in OPSCC; however, misdiagnosis rates of 5‑20% have been reported when using p16.³ The presence of E6/E7 mRNA is considered the gold standard for diagnosing HPV-related OPSCC.⁴ RNAscope offers a superior method for detection of E6/E7 mRNA when assessing HPV status in OPSCC patients, enabling clinicians to provide a more accurate diagnosis and improve patient management.⁵

"Bio-Techne's innovative tissue diagnostic solutions empower our customers to serve patients and improve lives," said Kim Kelderman, President, Diagnostics and Genomics Segment of Bio-Techne. "We are excited to launch the new CE-IVD RNAscope ISH Probe High Risk HPV, which provides pathologists a highly accurate tool for the direct detection of HPV mRNA to inform treatment selection in oropharyngeal squamous cell carcinoma patients." 

RNAscope in situ hybridization (ISH) is a highly sensitive and specific spatial biology technology. Its double Z probe design enables an exceptional signal-to-noise ratio when staining formalin-fixed paraffin-embedded (FFPE) tissue specimens. RNAscope ISH allows users to visualize and localize biomarker expression patterns by light microscopy. Over the past 10 years, RNAscope ISH has proven its reliability, reproducibility, and robustness with more than 6000 peer reviewed publications, making it a powerful solution for anatomic pathologists.

RNAscope ISH Probe High Risk HPV is used in an RNAscope ISH assay for the qualitative detection of HPV E6/E7 mRNA in 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 Leica Biosystems BOND-III stainer. 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.

To learn more about RNAscope ISH Probe High Risk HPV, please visit www.bio-techne.com/rnascope-hpv

About Bio-Techne Corporation (NASDAQ: TECH)

Contact:

David Clair, Senior Director, Investor Relations and Corporate Development david.clair@bio-techne.com 612-656-4416

References

1. Craig SG, Anderson LA, Schache AG, Moran M, Graham L, Currie K, Rooney K, Robinson M, Upile NS, Brooker R, Mesri M, Bingham V, McQuaid S, Jones T, McCance DJ, Salto-Tellez M, McDade SS, James JA. Recommendations for determining HPV status in patients with oropharyngeal cancers under TNM8 guidelines: a two-tier approach. Br J Cancer. 2019 Apr;120(8):827-833.
2. Lewis JS Jr, Beadle B, et al. Human Papillomavirus Testing in Head and Neck Carcinomas: Guideline from the College of American Pathologists. Arch Pathol Lab Med. 2018 May;142(5):559-597.
3. Huanhuan W, Yuyu Z, Wei B, et al. Feasibility of immunohistochemical p16 staining in the diagnosis of human papillomavirus infection in patients with squamous cell carcinoma of the head and neck: a systematic review and meta-analysis. Front Oncol. 2020;10:524928.
4. Bussu F, Ragin C, Boscolo-Rizzo P, Rizzo D, Gallus R, Delogu G, Morbini P, Tommasino M. HPV as a marker for molecular characterization in head and neck oncology: Looking for a standardization of clinical use and of detection method(s) in clinical practice. Head Neck. 2019 Apr;41(4):1104-1111.
5. Bishop JA, Ma XJ, Wang H, Luo Y, Illei PB, Begum S, Taube JM, Koch WM, Westra WH. Detection of transcriptionally active high-risk HPV in patients with head and neck squamous cell carcinoma as visualized by a novel E6/E7 mRNA in situ hybridization method. Am J Surg Pathol. 2012 Dec;36(12):1874-82.

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SOURCE Bio-Techne Corporation

FAQ

What is the RNAscope ISH Probe High Risk HPV launched by Bio-Techne?

It is a diagnostic tool for detecting HPV mRNA in patients with oropharyngeal squamous cell carcinoma, improving diagnostic accuracy.

How does the RNAscope ISH Probe High Risk HPV improve HPV detection?

It offers a more accurate diagnosis compared to traditional methods like p16 immunohistochemistry, significantly reducing misdiagnosis rates.

What types of HPV does the RNAscope ISH Probe detect?

It detects high-risk HPV types including 16, 18, 31, 33, and several others.

When was the RNAscope ISH Probe High Risk HPV launched?

It was launched on July 6, 2022.

Where can I find more information about the RNAscope ISH Probe High Risk HPV?

More information is available at Bio-Techne's website: www.bio-techne.com/rnascope-hpv.