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 plans to have its first CE-IVD marked SAGAsafe® assays in 2020.
*SAGAsafe® is currently available for research use only. Not for in vitro diagnostic use.