SAGAsafe® EGFR T790M
Mutation Detection AssaySAGAsafe® EGFR T790M
CE-marked SAGAsafe® assays currently available:
SAGAsafe® (formerly known as IBSAFE) is based on digital PCR (dPCR) and detects and quantifies mutations with unique ultrasensitivity to 0.001% MAF (Mutant Allele Frequency). This is approximately 100-fold improved compared to competing methods.
SAGA has developed and validated more than 250 different assays to date, covering most of the mutations of clinical interest.
Custom assays can be developed within a few weeks. A selection of these assays has been further validated in clinical research and, by hospital laboratories, for clinical diagnostic use*. SAGA has launched its first CE-IVD marked SAGAsafe® assay in 2020, paving the way for a pipeline of CE marked products in 2021 and beyond.
*Non-CE-IVD marked SAGAsafe® assays are currently available for research use only and not for in vitro diagnostic use.