Final guidance published today by healthcare guidance body NICE supports the use of a new colposcopy technology, DySIS (DySIS Medical), as a cost-effective option for examining the uterine cervix in women referred for colposcopy and recommends that it should be considered in procurement plans for colposcopy equipment. The guidance, which was produced as part of NICE's diagnostics assessment programme, also highlights that current evidence is insufficient to demonstrate that the Niris Imaging System (Imalux Corporation) is a cost-effective option for the same indication.

The success of the NHS cervical cancer screening programme has meant that cervical cancer is now a relatively uncommon type of cancer in the UK. In 2008 there were just under 2500 new cases diagnosed, accounting for around 2% of all cancers among women, making it the 12th most common cancer overall in women in the UK. However, it remains the most common cancer among women younger than 35 in the UK, with about 700 cases diagnosed annually.

Colposcopy is an examination that occupies a key role in the prevention of cervical cancer by identifying preinvasive or invasive lesions on a cervix. Referral to colposcopy depends on cytology results and the presence or absence of human papillomavirus, certain genotypes of which have been shown to be associated with the potentially premalignant transformation and abnormal growth of squamous cells on the surface of the cervix, and cervical cancer. Diagnosis is based on colposcopy results, with or without histology results (from a biopsy taken during the examination). However, the subjective nature of colposcopy means that it is prone to considerable inter- and intra-operator variation.

DySIS and Niris use different mechanisms that aim to improve the diagnostic accuracy of selection of patients for biopsy or treatment, aid in the selection of biopsy sites, and reduce the subjectivity of conventional colposcopy. The improved accuracy aims to enable more women to be appropriately treated for precancerous conditions and reduce the incidence of invasive cervical cancer. DySIS is an integrated digital image analysing (optical) system combined with a colposcope that evaluates the rate, extent and duration of acetowhitening - a test carried out during colposcopy to indicate the presence or otherwise of changes to the cells of the cervix. The dynamic map produced can be overlaid on a colour image of the tissue to help the clinician determine the presence and grade of any lesion.

Designed to aid in the detection and diagnosis of diseases, including cervical cancer, in their earliest stages, the Niris Imaging System uses optical coherence tomography as an adjunct to a standard colposcope. The major claimed benefit of the Niris system is its ability to provide an optical biopsy by visualising tissue microstructure to a depth of 1.6 mm.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The current method of examining the cervix to determine the extent of cell abnormalities, and whether any treatment is required, is prone to considerable inter- and intra-observer variation in interpretation of results, particularly for low grade lesions. This is because the current method relies on a visual examination of the cervix and is therefore subjective in nature. A technology that can improve diagnostic accuracy for cervical cancer clearly has the potential to impact on subsequent treatment decisions and improve patient outcomes. The independent Diagnostics Advisory Committee concluded that the evidence presented showed that DySIS is robustly cost effective -possibly even cost saving - when compared with conventional colposcopy. We are pleased, therefore, to be able to support the use of DySIS as a cost effective use of NHS resources. The Committee was unable to support the use of Niris at this time because of insufficient evidence.”

The diagnostics guidance for DySIS and Niris is available on the NICE website (from 1 August).

Ends

Notes to Editors

About the guidance

1. Women often develop changes in the cervix many years before any progression to cancer. These changes range from low-grade cervical intraepithelial neoplasia (CIN 1), which is frequently not precancerous but can cause changes that can be detected at cervical screening, to high-grade CIN (CIN 2/3), which is more frequently precancerous.

2. Infection with certain genotypes of human papillomavirus (HPV), in particular HPV 16 and HPV 18 (high-risk HPV), have been shown to be associated with the development of cervical cancer and CIN; almost all cervical cancers contain high-risk HPV DNA. However, most HPV infections will not progress to CIN. Some cell changes associated with HPV will regress to normal.

3. Certain risk factors are associated with the progression of HPV infection to CIN. These include the HPV genotype, early age at first sexual intercourse, long duration of the most recent sexual relationship and cigarette smoking.

4. In England, women are invited for regular cervical screening every 3 years (if aged between 25 and 49) or every 5 years (if aged between 50 and 64) under the NHS Cervical Screening Programme. Most screening is conducted using liquid-based cytology; a sample of exfoliated cells is brushed from the cervix for assessment in a pathology laboratory.

5. Cytological assessment is performed to detect nuclear abnormalities, which are described as dyskaryotic. The degree of dyskaryosis can range from mild to severe, or borderline changes may be seen.

6. The next step depends on cytology results and the presence or absence of high-risk HPV. According to the NHS Cervical Screening Programme guidelines, women with borderline or mild dyskaryosis on cytology who are also HPV positive should be referred for colposcopy. Those with borderline or mild dyskaryosis on cytology who are HPV negative are returned to routine recall. Women who have three consecutive inadequate samples or who have a test result showing moderate or severe dyskaryosis, possible invasion or possible glandular neoplasia, should be referred for colposcopy.

7. Once a colposcopic examination has been carried out, a diagnosis is made. This is based on colposcopy results, with or without histology results (from a biopsy that may be taken during the examination). Histological results are classified as normal, low-grade CIN, high-grade CIN or invasive carcinoma.

8. According to the NHS Cervical Screening Programme guidelines, these management and treatment options are linked to the four possible outcomes of a colposcopic exam and histology as follows:

• Normal: if the whole transformation zone is visible and is normal, the woman should be discharged and returned to routine cervical screening intervals.
• CIN 1: if the woman is diagnosed with CIN 1, she should be placed under observation (to be treated only if regression does not occur after 24 months). However, depending on the woman's choice, CIN 1 can also be treated.
• CIN 2 or 3: if the woman is diagnosed with CIN 2 or 3, she should be offered treatment either by ablation or large loop excision of the transformation zone.
• Invasive carcinoma: if the woman is diagnosed with invasive carcinoma she should be referred for either surgical or non-surgical management.

9. The acquisition cost of DySIS ranges from £18,000 to £22,000. DySIS includes a colposcope and no additional scope is needed when using DySIS. Costs for specula are £3.50 per examination.

10. The acquisition cost of Niris Imaging System is around £31,000 plus taxes and shipping. The probe costs around £1,700 and a disposable sheath costs around £19. A conventional colposcope is also needed when using Niris.

11. Conventional colposcopy is the comparator in this evaluation. Colposcopy is an essential part of the NHS Cervical Screening Programme. The purpose of a colposcopic examination is to identify lesions in a cervix that is already suspected of abnormality because cervical cytology is known to be abnormal. The average purchase price of a colposcope is £10,000 and maintenance cost is £1,000 per annum.

12. DySIS is manufactured by DySIS Medical. Niris Imaging System is manufactured by Imalux Corporation.

About the NICE Diagnostics Assessment Programme

13. Further information about the NICE diagnostics assessment programme can be found on the diagnostics page.

14. Topics to be considered by the Programme are routed through the related Medical Technologies Assessment Programme. Further information about this can be found on the NICE website.

About NICE

15. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

16. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

17. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

18. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.