Accelerated BRAF mutation analysis using a fully automated PCR platform improves the management of patients with metastatic melanoma

Abstract

Background: Determination of BRAF status is important for the therapeutic management of patients with metastatic melanoma. Objectives: We evaluated the impact of a faster determination of BRAF mutational status on the delay between initial consultation and initiation of treatment. Results: For the FA-PCR group a median delay of 16 days [11;18] was observed between initial consultation and the implementation of treatment, which was significantly lower than that observed for the SOP group (26 days [20;46], p = 0.035). Conclusions: In comparison to using conventional SOP, using an FA-PCR platform for BRAF mutation analysis of patients with metastatic melanoma significantly reduced the delay in initiation of personalized therapy by 10 days. Materials and Methods: Analysis of the BRAF mutation status of eight formalinfixed paraffin-embedded (FFPE) tissue samples was performed using a CE-IVD fullyautomated (FA) PCR-based platform. The delay between initial consultation and the implementation of treatment was compared between these samples (FA-PCR group) and a retrospective group of 29 FFPE samples analysed by standard operating procedures (SOP group) using conventional PCR.