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NICE draft guidance on cervical cancer diagnostics published for consultation

Draft guidance from NICE´s Diagnostics Assessment Programme on two new colposcopy technologies is issued today for public consultation. The provisional recommendations support the use of DySIS (DySIS Medical) as a cost-effective option for examining the uterine cervix in women referred for colposcopy. The draft guidance also highlights that current evidence is insufficient to demonstrate that the Niris Imaging System (Imalux Corporation) is a cost-effective option for the same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.

Cervical cancer is the 12th most common cancer in women in the UK and accounts for around 2% of all cancers among women. In 2008 there were just under 2500 new cases diagnosed. Among women younger than 35, cervical cancer is the most common cancer diagnosed (about 700 cases annually in the UK). In the UK, the lifetime risk of being diagnosed with cervical cancer has been estimated to be 1 in 134.

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).

Used in addition to conventional colposcopy, DySIS and Niris use different mechanisms that aim to aid in the selection of biopsy sites with improved diagnostic accuracy and eliminate the subjectivity of conventional colposcopy. 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.

The Niris Imaging System is a non-invasive device designed to aid in the detection and diagnosis of diseases, including cervical cancer, in their earliest stages, for precise guidance of biopsy and surgery, and for use in post-treatment surveillance. 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 guide treatment is prone to considerable inter- and intra-observer variation in interpretation of results, particularly for low grade lesions, because it relies on a visual examination of the cervix. 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 less costly and more effective than conventional colposcopy. The Committee was unable to recommend Niris as a cost-effective use of NHS resources at this time because of insufficient evidence."

The draft diagnostics guidance for DySIS and Niris is available on the NICE website at http://guidance.nice.org.uk/DT/5. The closing date for comments on the draft guidance is 24 April.

Ends

Notes to Editors

About the draft guidance

1. 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.

2. 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.

3. 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.

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

About the NICE Diagnostics Assessment Programme

5. Further information about the NICE diagnostics assessment programme can be found at: www.nice.org.uk/diagnostics

6. Topics to be considered by the Programme are routed through the related Medical Technologies Assessment Programme. Further information about this can be found at: www.nice.org.uk/mt

About NICE

7. 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.

8. 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.

9. 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

10. 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.

This page was last updated: 01 April 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.