NICE has been informed ofa change to clinical practice in KRAS mutation testing for identifying adults with metastatic colorectal cancer who may benefit from first-line treatment with cetuximab (Erbitux).Therefore, NICE has decided to discontinue the development of diagnostics guidance on ‘KRAS mutation testing of tumours in adults with metastatic colorectal cancer’ and consider the necessary companion diagnostic RAS testing within the upcoming review of the guidance on first-line use of cetuximab (TA176) and panitumumab (part review - TA240)
 
Status Discontinued
Process DT
Topic area
  • Cancer
  • Diagnostic procedures
  • Digestive system

Provisional Schedule

Scoping workshop: 3 December 2012
1st committee meeting: 04 September 2013
2nd committee meeting 06 November 2013

Project Team

Project lead Robert Fernley

Stakeholders

  • Manufacturer(s)

    • Qiagen Ltd.
    • Roche Molecular Systems, Inc.
    • Randox Laboratories Ltd.
    • ViennaLab Diagnostics GmbH
    • TIB MOLBIOL GmbH

    Manufacturer(s) of related technologies

    • Amgen
    • Merck Serono

    General, Professional /Patient carer groups

    • All Wales Genetics Laboratory
    • Association of Coloproctologists of Great Britain & Ireland (ACPGBI)
    • Birmingham Women's NHS Foundation Trust
    • Bladder & Bowel Foundation
    • Bowel Cancer UK
    • Bristol Royal Infirmary
    • Cheshire & Merseyside Regional Genetics Laboratories
    • Department of Health
    • European Molecular Genetics Quality Network (EMQN)
    • Guy's & St. Thomas NHS Foundation Trust
    • Lab21 Ltd.
    • Leeds Institute of Molecular Medicine
    • Mount Vernon Cancer Centre
    • NHS Lothian
    • Nottingham University Hospitals NHS Trust
    • Oxford BRC/NHS Molecular Diagnostic Centre
    • Queen Elizabeth Hospital Birmingham
    • Queen's University Belfast
    • Royal College of Nursing
    • Royal College of Pathologists
    • Royal College of Physicians
    • Royal Devon and Exeter NHS Foundation Trust
    • Sheffield Diagnostic Genetics service
    • St. Mary's Hospital, Central Manchester University Hospitals NHS Foundation Trust
    • The Royal Marsden NHS Foundation Trust
    • UK NEQAS for Molecular Genetics
    • University Hospitals Birmingham NHS Foundation Trust
    • Wessex Regional Genetics Laboratory

    Definition:

    Registered stakeholders

    Individuals or organisations interested in a topic being evaluated by the Diagnostics Assessment Programme, and who register to become a stakeholder. For example, manufacturers of thetechnology, national organisations that represent healthcare professions who operate or use the results of the technology, national patient or carer organisations, NHS service providers and commissioners, statutory organisations and research organisations.

     

Timeline

Key events during the development of the guidance:

Date Update
11 September 2014 Discontinued, NICE has been informed ofa change to clinical practice in KRAS mutation testing for identifying adults with metastatic colorectal cancer who may benefit from first-line treatment with cetuximab (Erbitux).Therefore, NICE has decided to discontinue the development of diagnostics guidance on ‘KRAS mutation testing of tumours in adults with metastatic colorectal cancer’ and consider the necessary companion diagnostic RAS testing within the upcoming review of the guidance on first-line use of cetuximab (TA176) and panitumumab (part review - TA240)
11 September 2014 NICE has been informed ofa change to clinical practice in KRAS mutation testing for identifying adults with metastatic colorectal cancer who may benefit from first-line treatment with cetuximab (Erbitux).Therefore, NICE has decided to discontinue the development of diagnostics guidance on ‘KRAS mutation testing of tumours in adults with metastatic colorectal cancer’ and consider the necessary companion diagnostic RAS testing within the upcoming review of the guidance on first-line use of cetuximab (TA176) and panitumumab (part review - TA240).
22 November 2013 The Institute has been informed by stakeholders that recently published evidence may result in changes to clinical practice for KRAS mutation testing. Therefore, the Institute has decided to suspend the development of guidance on ‘KRAS mutation testing of tumours in adults with metastatic colorectal cancer’ pending a fuller understanding of any changes that might occur. We will update interested parties with further information regarding this guidance.

For further information on how we develop guidance, please see our page about NICE diagnostics guidance