DxS K-Ras mutation detection kit used to assess tumour mutation status prior to treatment with Amgen's Vectibix
Amgen has selected the DxS K-Ras cancer mutation detection kit to analyse patient samples from the pivotal '408' study examining Vectibix versus best supportive care in patients with metastatic colorectal cancer who have progressed after all available chemotherapy regimens.
The drug has now received a recommendation from the European Committee for Medicinal Products for human use for conditional marketing authorisation from the European Medicines Agency for treating patients with refractory metastatic colorectal cancer whose tumours do not have a mutation of K-Ras.
DxS is a personalised medicine company specialising in molecular diagnostics for detecting mutations in tumours.
Understanding cancer mutation status can help select the optimal drug therapy for a patient.
At Ecco 14 - the European Cancer Conference - Amgen presented 'Analysis of K-Ras mutations in patients with metastatic colorectal cancer receiving panitumumab monotherapy', which involved use of the DxS K-Ras cancer mutation detection kit.
The study concludes that the efficacy of panitumumab monotherapy in metastatic colorectal cancer seems confined to patients with non-mutated K-Ras.
The test utilised is highly selective and robust, detecting seven key mutations in the K-Ras gene.
DxS assays employ a real-time PCR format combining Scorpions and Arms (allele specific PCR) technologies.
The assays can detect <1% of mutant in a background of wild type genomic DNA and have a limit of detection of 10 copies or below.
The unparalleled sensitivity of the technology means that the kit detects mutations frequently missed by sequencing methods.
DxS is currently in discussion with regulatory authorities and service providers to ensure that an approved diagnostic is available to support the launch of Vectibix.
Commenting on the data, Stephen Little (CEO, DxS ) says, "We are very pleased that Amgen chose the DxS K-Ras mutation kit and have benefited from the excellent selectivity of the test to maximise the number of mutation positive individuals correctly identified in the analysis of tumour samples from the Vectibix pivotal study.
"K-Ras genotyping of tumours should now be considered in patients with metastatic colorectal cancer being treated with or considered for Vectibix monotherapy."
