TEST:

Idylla™ NRAS-BRAF Mutation Test

P2; Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

Our results highlighted a difference in the molecular profile of KRAS, NRAS,and BRAF mutations' distribution between metastatic colorectal cancer and non-metastatic ones: NRAS and BRAF mutations were associated with metastasis advent; moreover, the G13D mutation of KRAS was correlated to a better prognosis than mutations in codon 12 of KRAS: G12A and G12S alleles gave the worst prognosis.

The patient was given folforinox + avastin during 3 months, then Avastin+Xeloda as maintenance treatment. The question is: "Are RAS and BRAF mutations really exclusive to each other"? It seems difficult to answer: even if it's a rare event, it is important to search for BRAF mutations even if RAS is mutatedin specific patients.

"Biocartis Group NV...announces the publication of nine performance study abstracts of its fully automated molecular diagnostics Idylla™ platform and assays at the annual meeting of the ‘Association for Molecular Pathology’ (AMP), a leading molecular diagnostics conference, taking place between 1-5 November in Phoenix, Arizona (US). The studies were performed by a variety of US laboratories and research institutes."

"This result demonstrates a high concordance between the Idylla KRAS and NRAS-BRAF Mutation Tests and an existing IVD kit. In this manner, the Idylla mutation tests were validated for the detection of clinically significant KRAS, NRAS, and BRAF mutations in FFPE samples from colorectal cancer patients."

Our results demonstrate that the Idylla BRAF Mutation Assay produces accurate, precise results in less than 3 hours, with faster TAT compared to NGS. Single-use cartridges eliminate the need for manual sample preprocessing and the risk of PCR contamination. In addition, this sensitive assay correctly identifies BRAF V600 alterations in samples with necrosis and low tumor cell content.