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The GeneSTAT® System

Available in low-throughput, legacy, and high-throughput platforms, the GeneSTAT® System is a unique and disruptive test technology focused on infectious disease agents and antibiotic resistance.

Performance

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.

Efficiency

Short time to results and minimal hands-on time required.

Cost-Effectiveness

Low consumable cost provides pricing flexibility.

Reliability

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