The GeneSTAT® System
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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.

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.
High Performance UI
Low consumable cost provides pricing flexibility.
Rugged design with minimal maintenance required.

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

Recent Studies Prove Our System

  • GeneSTAT / assay performance: peer-reviewed journal, FDA clearance
  • Robustness of instrument and assay design / development capabilities
  • Improved lab workflow

Low-Throughput (Point of Care)

GeneSTAT Molecular Diagnostics, LLC (GMD) has developed a low-throughput, patented, and novel Real-Time PCR system that brings the benefits of molecular testing technology to underserved small to mid-sized community hospitals, physician clinics and rural healthcare facilities where the cost or complexity of other systems has not traditionally been viable. Appropriate for diverse environments, the low-throughput GeneSTAT Instrument employs a simple, single test format using real-time PCR technology for testing functions, in an instrument with a small footprint with just 4 moving parts.

The GeneSTAT® System puts these testing capabilities closer to the provider and patient who needs results quickly, while providing the diagnostic performance seen with larger more complex and costly laboratory molecular testing systems. For situations where a higher testing capacity is desired, multiple instruments can be combined and operated off a single laptop computer. The results from testing can be read either on the instrument itself or on the attached laptop computer.

The Instrument platform and the test cartridge each are critical aspects of the GeneSTAT System’s ability to provide testing at the point of need, with minimal laboratory training or experience necessary.

Accessible to Underserved Areas

  • Cartridges with lyophilized reagents have no special storage requirements
  • The GeneSTAT instrument platform is simple in design providing for durability and portability
  • Operation of the GeneSTAT requires no specially trained molecular lab technologist (little or no laboratory experience required)
  • Single test system means no waiting for complete batches to begin testing
  • The closed cartridge system eliminates the effects of ambient conditions
  • Closed cartridge eliminates PCR product contamination issues
  • High value, low cost system is highly accessible to many different clinical environments
  • Profitable to hospital or clinic using current CPT codes
  • Short turn-around time to test results

Easy to Use

  • Patented single-use cartridge contains all necessary reagents for detecting DNA/RNA targets
  • Requires no highly trained technologist, so can be run 24/7
  • Limited hands-on requirement facilitates testing during lower staffing times
  • Complexity of instrument and cartridge procedurally meets CLIA waived requirements
  • RFID tag (not the operator) provides all testing information to the instrument
  • Minimal maintenance with no user calibration needed

Contact us to learn more about how the GeneSTAT System may meet your needs.