CE-marked SAGAsafe® assays currently available:

SAGAsafe® EGFR T790M

Mutation Detection Assay

SAGAsafe® EGFR T790M

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.

The principle of the SAGAsafe® technology: standard methods cause detection noise which increases the risk of false results. SAGAsafe® eliminates detection noise which makes it possible to accurately detect point mutations even at 0.001% MAF.

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.

The ultrasensitivity of SAGAsafe® enables accurate detection and quantification of point mutations down to 0.001% MAF. This is an 100-fold improvement compared to competing methods. Competing methods are accurate down to 0.1% MAF, beyond this point the results have a high risk of so called false positives.

*Non-CE-IVD marked SAGAsafe® assays are currently available for research use only and not for in vitro diagnostic use.