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Validation of a novel diagnostic standard in HPV-positive oropharyngeal squamous cell carcinoma

Lookup NU author(s): Professor Philip Sloan, Dr Max RobinsonORCiD


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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.

Publication metadata

Author(s): Schache AG, Liloglou T, Risk JM, Jones TM, Ma X-J, Wang H, Bui S, Luo Y, Sloan P, Shaw RJ, Robinson M

Publication type: Article

Publication status: Published

Journal: British Journal of Cancer

Year: 2013

Volume: 108

Pages: 1332-1339

Print publication date: 14/02/2013

ISSN (print): 0007-0920

ISSN (electronic): 1532-1827

Publisher: Nature Publishing Group


DOI: 10.1038/bjc.2013.63


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