K Cuschieri, Scottish HPV Reference Lab Presented at SMVN Laboratories and Specialised Services Meeting, March 2013

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Scottish HPV Reference Lab K Cuschieri, Scottish HPV Reference Lab Presented at SMVN Laboratories and Specialised Services Meeting, March 2013

About us Established 2008 Based at RIE Team of 7

Functions of SHPVRL HPV testing for Epidemiology and Surveillance of the HPV immunisation programme HPV testing, support and advice for the Scottish Cervical Screening Programme HPV screening / genotyping in individual clinical cases where knowledge of HPV status will inform clinical management Provision of quality assurance and assessment materials for UKwide HPV testing laboratories and beyond Commitment to a research and development programme through collaboration with NHS partners, academia and industry Consolidation of HPV sample archives to facilitate research, quality assurance, test development, audit and teaching.

SHPVRL - Key Interactions HPV Surveillance Team at HPS Scottish Cervical Screening Programme Clinical Users HPV Research Group (U of E) where HPV Archive is based Research Partners

Features of HPV/HPV testing Stable ds DNA genome ~15 high risk HPV types, some riskier than others in this category. Likely that HPV testing (using consensus tests for HR-HPV) will become primary cervical screening modality Most HPV infections transient & asymptomatic, even high-risk ones. Current commercial HPV tests cannot delineate between clinically significant and insignificant HPV infections Genotyping essential for surveillance and some clinical i l work No anti-viral, knowledge of HPV sequence wouldn t influence therapy HPV associated oropharyngeal cancer is rising as is our knowledge as to how HPV testing can inform mangament of this disease

The future. Immunisation will change pattern of cervical disease Scotland in unique position to look at this impact Will immunisation engender type replacement..? Increasing amount of HPV testing for service, including testing beyond the cervix HPV tests themselves are not static, developments underway to improve specificity Still much we don t know about the virus.

The future (2) Surveillance Carry on typing HPV variant analysis relevant for increasingly immunised population, serological assays for breakthrough infections, Vaccine failures Research Design of more specific diagnostic (sophisticated viral and/or cellular target) Clinical Application of above to risk stratify: tif Disease (pre-invasive & invasive, cervical & head and neck) Infection (eg - Cervical Screen HPV positives)

The Scottish HPV Investigators Network (SHINe, est 2008) Purpose The purpose of SHINe is to act as a multi-disciplinary forum for discussion on HPV and HPVrelated diseases, identify emerging research and clinical questions, and implement a series of research programmes/projects relevant to HPV disease prevention and management in the future. The group benefits from the combined expertise of representatives from cervical screening (Primary Care and Cytology), disease management/treatment (Pathology, Gynaecology and Colposcopy) and internationally recognised basic scientists. In addition, representation from the Scottish HPV Reference Laboratory (SHPVRL) and the team at Health Protection Scotland responsible for National Immunisation and surveillance make SHINe a truly relevant and integrated collaboration. Funding has already been obtained from the Chief Scientist Office of the Scottish Government Health Department with two concurrent programme grants, one of which has ensured the development of a National HPV sample archive. http://www.shine.mvm.ed.ac.uk

Selected Research Projects Cervical HPV infection in vaccinated and unvaccinated women new markers of infection, immunity and disease. Chief Scientist Office (CSO) Scottish Cervical Cancer Prevention Programme: Establishing an HPV Clinical Research Centre for long-term follow-up of HPV infection and associated disease in a vaccination era. (CSO) The Scottish Cervical Cancer Prevention Programme: Assessing and modelling the impact of HPV16/18 immunisation i on the performance of current cervical screening performance and the effectiveness of alternative cervical screening strategies to optimise cancer prevention in the HPV immunisation era. (CSO) The Prevalence of HPV associated Oropharyngeal Squamous Cell carcinoma in the UK (GSK) Submitted: HPV Oral Prevalence in Scotland (HOPSCOTCH) Feasibility Study