Recent internal and external studies prove laboratory value and potential clinical value.
Ease of Use
Minimal expertise is required to operate with 24/7 actionable results.
Short time to results and minimal hands-on time required.
Low consumable cost provides pricing flexibility.
Rugged design with minimal maintenance required.
Recent Studies Prove Our System
- GeneSTAT / assay performance: peer-reviewed journal, FDA clearance
- Robustness of instrument and assay design / development capabilities
- Improved lab workflow
Verified Performance and Robustness
- Risk analysis = verified design
- Sensitivity, 100%; specificity 99.6%
- Precision repeatability: 87.5% — 100%
- Reproducibility: multiple GeneSTATs, cartridge lots and technologists — 100% across all
- LOD studies: 10 GEq/ml
- Microorganism interference: none
- Cross reactivity: none = robust probe and primer design
- Interfering substances: none
- Carryover cross-contamination: none, by design
- Shelf life: 6 months to 18 months at ambient temperature
- Firmware / software trace verified as per FDA requirements
- External multicenter blinded study proves GeneSTAT System performance