The future of human papillomavirus DNA testing in cervical screening

Each year, over three million women are screened in England as part of the NHS Cervical Screening Programme.1 Cervical cancer is the most common cancer in females aged under 35, with approximately 2938 women diagnosed with invasive cervical cancer every year in the UK.2 The current system of cervical screening was introduced across the NHS in 1988 when the Department of Health instructed all health authorities to introduce computerised call-recall systems and to meet certain quality standards. Women between the ages of 25 and 64 are now invited to attend screening every three or five years, depending on their age. It is estimated that over 3.7 million samples were examined by pathology laboratories in 2010–2011, and 3.4 million (93.2%) of these were submitted by GPs and NHS community clinics.3

Implementation of HPV triage
It is now known that infection with high-risk human papillomavirus (HPV) is a key factor in the development of cervical cancer.4 The virus is the principal cause of cervical cancer in women and is present in more than 99% of cervical cancers worldwide. The HPV types 16 and 18 are estimated to be responsible for about 70% of all cases of cervical cancer.5 Although cytology has been the traditional method for cervical screening, recent studies have shown that HPV DNA testing has a higher sensitivity for detecting cervical precancer.6 The evaluation of the HPV/liquid-based cytology (LBC) cervical screening pilot studies conducted in 2001 showed that introducing HPV triage into the NHS Cervical Screening Programme was feasible, acceptable and cost-effective in terms of quality and of life years saved.7 As a result, HPV triage is currently being rolled out as part of the NHS National Cervical Screening Programme in England

cobas HPV test
As part of the NHS triage roll out, the Roche cobas HPV test is now available. The cobas HPV test is the only US Food and Drug Administration (FDA)- and CE-IVD-approved screening test available in the UK and globally that individually identifies genotypes 16 and 18, while simultaneously detecting 12 other high-risk HPV genotypes. Roche’s cobas HPV test simultaneously detects 12 high-risk HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) as a pooled result, as well as HPV genotypes 16 and 18 individually. For laboratory professionals, the test also offers maximum ease of use, reliability and flexibility. Key features such as the ‘load and go’ facility for reagents mean that the cobas HPV test is easy and simple to use with minimal hands-on and maximum walkaway time, while providing high-throughput capabilities, and has the flexibility to meet smaller-throughput requirements.