The features
- Highest sensitivity and specificity, 100- to 1000-fold improved
- Performed on cfDNA obtained from a simple blood sample
- Rapid turn-around time (1 day sample to result)
SAGAsafe® EGFR T790M
mutation detection kit
Detect and quantify EGFR T790M mutations in blood with our first CE-IVD-marked SAGAsafe® assay.
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Learn MoreSAGAsafe® EGFR T790M
mutation detection kit
Detect, quantify, and monitor EGFR T790M mutations in blood with unparalleled sensitivity.
The SAGAsafe® EGFR T790M assay (CE-IVD) achieves industry-leading superior performance by employing the patented ultrasensitive SAGAsafe® digital PCR technology which in comparison to traditional approaches enhances true-positive signals and at the same time reduces false-positive signals. This leads to a 100- to 1000-fold improvement in detection limit compared to competitor technologies and kits.
SAGAsafe® EGFR T790M is performed on cfDNA obtained from a simple blood sample which means that patient material is easily available and allows for rapid and low-cost repetition of testing.
Technical details
| Mutation targeted | EGFR p.T790M (c.2369C>T) |
| Regulatory status |
CE IVD
|
| Technology | Digital PCR |
| System | Validated on the Bio-Rad QXDx™/QX200™ ddPCR™ system |
| Sample type | cfDNA derived from plasma samples |
| Kit sizes available | 25 samples or 100 samples |
Limit of Blank (LoB) and Limit of Detection (LoD) at maximum loading and with 95% confidence interval
| 95% CI | Limit of Blank | Limit of Detection |
| SAGAsafe® EGFR T790M test | 0.0010% MAF | 0.0037% MAF |
This product is not commercially available in all countries.