Horizon Scanning Centre) New and emerging self-sampling technologies for Human Papillomavirus (HPV) testing March 2014 1 This report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR Horizon Scanning Centre, University of Birmingham, United Kingdom [email protected] http://www.hsc.nihr.ac.uk/ Copyright © University of Birmingham 2014 2 CONTENTS CONTENTS Executive summary ………………………………………………………………………… 5 Acknowledgments ....................................................................................................... 5 1. Introduction .............................................................................................................. 6 1.1 NHS Cervical Screening .......................................................................................... 6 1.2 HPV testing .............................................................................................................. 7 1.3 HPV self-sampling …………………………………...…………………………………... 7 1.3.1 Proof of concept ............................................................................................... 8 1.3.2 Technology types ............................................................................................ 9 1.4 Aim & objective …………………………………………………………………………. 10 2. Methods .................................................................................................................. 10 2.1 Inclusion criteria ..................................................................................................... 10 2.2 Review process ...................................................................................................... 11 2.2.1 Identification of technologies ... ...................................................................... 11 2.2.2 Expert advice ................................................................................................. 12 3. Results .................................................................................................................... 12 3.1 Technologies by type.............................................................................................. 13 3.2 Sample transit – dry versus liquid…....................................................................... 13 4. Discussion .............................................................................................................. 14 4.1 The sampling device – what matters? …................................................................ 14 4.1.1 User acceptability ......................................................................................... .15 4.1.2 Sampler design ................................................................................... ……….15 4.1.2.1 Applicator or stick?.................... ........................................................... .15 4.1.2.2 Swab or brush?.................... ................................................................. .16 4.2 Sampling method …………………………………………………………………..…... 17 4.2.1 Instructions for use.................... ..................................................................... 17 4.2.2 Accidental detachment .................................................................................. 17 4.3 Post-sampling method …………………………………………………………………..17 4.3.1 Sample transfer.............................................................................................. 17 4.3.2 Dry or liquid? .................................................................................................. 17 4.3.3 Labelling and consent .................................................................................... 18 4.4 Transportation …………………………………………………………………………... 18 4.4.1 Dry transportation.................... ...................................................................... 18 4.7 Cost……………………............................................................................................ 19 4.8 Innovations in HPV testing……............................................................................... 19 5. Summary ................................................................................................................. 19 3 Appendices Appendix 1 Advisory Group ………………………………………………………………... 20 Appendix 2 Technologies marketed or in development for HPV self-sampling use .... 21 Appendix 3 Technologies that might have potential for HPV self-sampling use …...... 28 Appendix 4 Pictures of some of the technologies ……………………………..……….... 38 References ……………………………………………………………………...…………... 45 4 EXECUTIVE SUMMARY This review aims to identify new and emerging technologies for cervicovaginal self- sampling for human papillomavirus (HPV) testing. Infection with HPV is the main risk factor and a necessary cause of cervical cancer. Cervical cancer is the twelfth most common cancer in women in the UK, and the third most common gynaecological cancer1. It caused 781 deaths in England in 20112. The NHS Cervical Screening Programme screens over three million women in England each year3. In order to identify relevant technologies, the review used five sources of intelligence: 1. Consultation with: • commercial developers. • clinical and scientific experts. • trade associations. 2. Searching: • online sources of information (e.g. clinical trial and bibliographic databases, and the medical media). • NIHR Horizon Scanning Centre in-house technology database. A total of 43 technologies were identified. Of these, 17 are either currently marketed (or are being developed) specifically for self-sampling use. The remaining 26 technologies might have potential for self-sampling use. ACKNOWLEDGEMENTS Internal review team Dr Sara Trevitt Senior Analyst Dr Sue Simpson Associate Director Dr Annette Wood Medical Advisor Advisory Group Ms Catherine Witney NHS Cancer Screening Programmes Mrs Janet Rimmer NHS Cancer Screening Programmes Ms Samantha Fletcher Central Manchester University Hospitals NHS Foundation Trust Dr Kate Cuschieri Scottish HPV Reference Laboratory. 5 1. INTRODUCTION The review was conducted at the request of the NHS Cancer Screening Programmes (a part of Public Health England) to provide an early intelligence report on new and emerging self-sampling technologies that can or could potentially be used for HPV testing. 1.1 NHS CERVICAL SCREENING Cervical screening is a method of preventing cancer by detecting and treating early abnormalities which, if left untreated, could lead to cancer in a woman's cervix (the neck of the womb)4. In England, the NHS Cervical Screening Programme (NHSCSP) offers cervical screening to all women aged between 25 and 64 years. After the first cervical screen, repeat invitations are sent out every three years between the ages of 25 and 49 years and every five years between the ages of 54 and 64 years. Current cervical testing uses a method called liquid-based cytology (LBC). The sample is taken by a healthcare professional (nurse or doctor) in a primary care setting, such as a GP surgery. An instrument called a speculum is inserted into the vagina to hold it open, whilst a small brush-like device is wiped over the cervix to pick up cells. This sample of cells is then placed into a small container of liquid. Obtaining the sample takes a few minutes, and some woman may experience some discomfort or pain. The sample is then sent to a laboratory for the cells to be transferred onto a slide and examined microscopically (called cytology). More than 3.5 million women were screened by the NHS Cervical Screening Programme in England in 2011/20125. According to figures reported in 2012, cervical screening coverage in England (the proportion of women screened within the previous five years) has remained consistently high over the past 20 years5. However, there has been a gradual decline from 82% coverage in the late 1990s to 79% in the five years up to 2012. The fall in coverage of 0.3% (78.6% down to 78.3%) between March 2012 and March 2013 was most notable among women aged 25 to 49 years6. The reasons that women do not attend for screening are complex, but include7: • Emotional/personal barriers, e.g. embarrassment, fear of discomfort or pain, fear of the result, preference for a female nurse/doctor. • Practical and organisational barriers, e.g. travel difficulties, childcare issues, work commitments. • Knowledge/awareness barriers, e.g. lack of understanding about the causes of cervical cancer and the purpose of screening. • Demographic factors, e.g. being from a specific ethnic minority group or a deprived background. Cervical cancer caused 781 deaths in England in 20112. Many women who develop the disease have not been screened regularly, and not undergoing cervical screening is one of the greatest risk factors for developing cervical cancer. Regular cervical screening is the best way to detect changes to the cervix before cancer develops. Early detection and treatment can prevent around 75% of cervical cancers from developing4. 6 Cervical cancer is more common in women who smoke, first had sex at an early age, have had several sexual partners, have had a sexual partner who has had several other partners, or take immunosuppressant drugs. 1.2 HPV TESTING Human papillomavirus (HPV) is a common infection that most women will get at some time in their life. It shows no symptoms. HPV is easily transmitted during intimate sexual contact between partners. There are