RNAscope™ ISH Probe High Risk HPV for Head & Neck Cancer

Human papillomavirus (HPV) and Oropharyngeal Squamous Cell Carcinomas (OPSCC)

Human papillomavirus (HPV) is a major cause of oropharyngeal squamous cell carcinomas, and HPV status has emerged as a prognostic marker that significantly impacts clinical management.1 As HPV-driven carcinomas are dependent on the permanent over-expression of the HPV E6 and E7 viral oncogene mRNAs, the presence of E6/E7 mRNA is considered to be the best biomarker for identifying HPV-related head and neck cancers.2,3 Common techniques for HPV detection in OPSCC, including DNA ISH and p16 immunohistochemistry (IHC), often lead to false positives or false negatives. Previous studies reported 5–20% false positive rate of p16 IHC positivity in HPV-negative OPSCC patients.4
RNAscope in situ hybridization (ISH) gives anatomic pathologists a direct method for detection of active HPV through interrogation of E6/E7 viral oncogene mRNA, targets that provide unequivocal evidence of HPV in contrast to p16, a surrogate marker, which is upregulated by HPV as well as other non-HPV pathways. 

Detection of High Risk HPV in FFPE Tissue Specimens Using RNAscope

The ease of adoption of RNA ISH technology on the automated Leica Biosystems BOND-III stainer has enabled laboratories to quickly establish this technology, minimizing inter-user variation and optimizing sample pretreatment. RNAscope ISH Probe High Risk HPV is for use in clinical laboratories with the CE marked BOND RNAscope Brown Detection on the BOND-III stainer. The assay qualitatively detects E6/E7 mRNA of high-risk HPV type 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82 in FFPE tissue specimens (Figure 1) .


Oropharyngeal squamous cell carcinoma FFPE tissue stained with RNAscope ISH Probe High Risk HPV
FIGURE 1: RNAscope ISH Probe High Risk HPV (cocktail including HPV types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, & 82)
Tissue: Oropharyngeal squamous cell carcinoma (OPSCC)


Product No. Product DescriptionRegulatory StatusSize/Tests
200450RNAscope ISH Probe High Risk HPVCE-IVD14 ml/30 tests
200460RNAscope ISH Probe UBC (Positive Control) CE-IVD14 ml/30 tests
200470RNAscope ISH Probe dapB (Negative Control) CE-IVD14 ml/30 tests

For In Vitro Diagnostic Use Only
The clinical interpretation of any hybridization signal or its absence should be performed by a qualified pathologist with proper controls, complemented by histological examination and relevant clinical information.



  1. 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.
  2. Schache, A.G., Liloglou, T., et al. (2011). Evaluation of human papilloma virus diagnostic testing in oropharyngeal squamous cell carcinoma: sensitivity, specificity, and prognostic discrimination. Clin. Cancer Res. 17, 6262–6271.
  3. Shi, W., Kato, H., et al. (2009). Comparative prognostic value of HPV16 E6 mRNA compared with in situ hybridization for human oropharyngeal squamous carcinoma. J. Clin. Oncol. 27, 6213–6221.
  4. 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.
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