Abstract
BACKGROUND: Human papillomavirus (HPV) testing in oropharyngeal squamous cell carcinoma (OPSCC) is now advocated. Demonstration of transcriptionally active high-risk HPV (HR-HPV) in fresh tumour tissue is considered to be the analytical 'gold standard'. Clinical testing has focused on formalin-fixed paraffin-embedded (FFPE) tissue at the expense of sensitivity and specificity. Recently, a novel RNA in situ hybridisation test (RNAscope) has been developed for the detection of HR-HPV in FFPE tissue; however, validation against the 'gold standard' has not been reported.
METHODS: A tissue microarray comprising FFPE cores from 79 OPSCC was tested using HR-HPV RNAscope. Analytical accuracy and prognostic capacity were established by comparison with the reference test; qRT-PCR for HR-HPV on matched fresh-frozen samples.
RESULTS: High-risk HPV RNAscope had a sensitivity and specificity of 97 and 93%, respectively, against the reference test. Kaplan-Meier estimates of disease-specific survival (DSS, P=0.001) and overall survival (OS, P<0.001) by RNAscope were similar to the reference test (DSS, P=0.003, OS, P<0.001) and at least, not inferior to p16 immunohistochemistry +/- HR-HPV DNA-based tests.
CONCLUSION: HR-HPV RNAscope demonstrates excellent analytical and prognostic performance against the 'gold standard'. These data suggest that the test could be developed to provide the 'clinical standard' for assigning a diagnosis of HPV-related OPSCC.
Original language | English |
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Pages (from-to) | 1332-9 |
Number of pages | 8 |
Journal | British Journal of Cancer |
Volume | 108 |
Issue number | 6 |
DOIs | |
Publication status | Published - 2 Apr 2013 |
Keywords
- Biomarkers, Tumor/genetics
- Carcinoma, Squamous Cell/diagnosis
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Molecular Diagnostic Techniques
- Neoplasm Staging
- Oropharyngeal Neoplasms/diagnosis
- Papillomaviridae/genetics
- Papillomavirus Infections/diagnosis
- Polymerase Chain Reaction
- Prognosis
- RNA, Viral/genetics
- Survival Rate
- Tissue Array Analysis