Biomarkers can predict if a patient with a given disease, who shows certain biological characteristics, has a greater probability of responding to a particular therapy, compared with those who do not have the characteristic. This can be determined by biomarker testing. Sometimes these are referred to as ‘therapy management’ or ‘selective’ biomarkers.
It is a biological characteristic that can be objectively measured and evaluated, and acts as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
Over 45 mutations have been identified in the BRAF gene (found on chromosome 7), occurring at a high frequency in specific cancers, including approximately 30–60% of melanomas.1,2
Some specific mutations in exon 15 have a clear role in altering the MAP kinase pathway, and stimulation of cellular growth by inhibition of pro-apoptotic signals.2,3 These mutations are targeted by clinically proven therapeutic agents. Therefore, testing for BRAF mutations is done to identify patients who are suitable for advanced melanoma treatment with these BRAF inhibitors.
Biomarker testing helps identify patients who are most likely to respond to particular therapies, and may also provide an indication of aggressive disease or poor prognosis.4,5
For patients with advanced melanoma, accurate, timely, and reliable identification of BRAF mutations is essential to ensure appropriate disease management.