GeneSTATMolecularDiagnostics,LLC 435-635-5553

Molecular Testing: At the: Point of Need / Point of Care

GMD, LLC 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.  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. 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.

The GeneSTAT System is CE marked and FDA-Cleared for the GeneSTAT.MDx Coccidioides test (Valley Fever).  both clinical and surveillance tests are currently being implemented and optimized on the system in preparation for regulatory clearances in the US, Europe and the Pacific Rim.

  • 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
  • The closed cartridge system eliminates the effects of ambient conditions
  • Closed  cartridge eliminates PCR product contamination issues
  • High value, low cost system makes it highly accessible to many different clinical environments.
  • Profitable to hospital or clinic using current CPT codes
  • Short turn-around time to test results

  • Single test system means no waiting for complete batches to begin testing
  • Requires no highly trained technologist so can be run 24/7
  • Limited hands on requirement facilitates testing during lower staffing times
  • Short turn-around time to test results

  • Easy to run: 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
  • No molecular experience required (little or no laboratory experience required)