Quality standard
Quality statement 5: Genetic testing
Quality statement 5: Genetic testing
Quality statement
People with stage IIB to IV primary melanoma have BRAF analysis of the tumour. [2016, updated 2024]
Rationale
BRAF analysis should be carried out on melanoma tissue samples from people with stage IIB to IV primary melanoma. Early determination of BRAF status helps to optimise the use of targeted treatments and may speed up decisions about treatment for relapsed melanoma.
Quality measures
The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.
Process
Proportion of people with stage IIB to IV primary melanoma who have BRAF analysis of the tumour.
Numerator – the number in the denominator who have BRAF analysis of the tumour.
Denominator – the number of people with stage IIB to IV primary melanoma.
Data source: Data on performance of immunohistochemistry tests can be collected from information recorded locally by provider organisations, for example from patient records. National Cancer Registration and Analysis Service Cancer Outcomes and Services Dataset – Core records the gene or stratification biomarker analysed (including BRAF), date reported and reporting laboratory as part of the section on somatic testing for targeted therapy and personalised medicine.
What the quality statement means for different audiences
Service providers (such as secondary care services, tertiary care services and laboratory services) ensure that systems are in place to provide BRAF analysis of the tumour for people with stage IIB to IV primary melanoma.
Healthcare professionals (such as histopathologists, oncologists or members of a local or specialist skin cancer multidisciplinary team) arrange BRAF analysis of the tumour for people with stage IIB to IV primary melanoma and state the preferred tissue block for analysis.
Commissioners ensure that they commission services that provide BRAF analysis of the tumour to people with stage IIB to IV primary melanoma.
People with a type of skin cancer called primary melanoma (at stages IIB to IV) have genetic testing of their tumour to help find out whether a type of drug treatment called targeted therapy might be suitable for them. It can also help to speed up treatment decisions if the cancer comes back.
Source guidance
Melanoma: assessment and management. NICE guideline NG14 (2015, updated 2022), recommendation 1.3.10
Definitions of terms used in this quality statement
BRAF analysis
Analysis of the BRAF gene in melanoma tissue samples from people with stage IIB to IV primary melanoma. Local or specialist skin cancer multidisciplinary teams should specify the preferred tissue block for analysis. Consider immunohistochemistry as the first test for BRAF V600E, if available. [NICE's guideline on melanoma, recommendations 1.3.10 to 1.3.12 and evidence review A: genetic testing for melanoma]