GenestatMolecularDiagnostics,LLC 435-635-5553 info@genestatmdx.com

Pipeline of Tests

The GeneSTAT Pipeline of Tests 

The GeneSTAT Molecular Diagnostics (GMD) ongoing development strategy consists of three programs, with pipeline development focused on infectious disease: 

  • Strategic Clinical Tests
  • Tactical Clinical Tests
  • Tactical Non-clinical Tests
Meeting Unmet Needs
Strategic Clinical Tests
Our Strategic Clinical Tests will be designed to address a clinical condition where there is currently no effective, rapid diagnostic test and there is a clear unmet need. These unique, high value tests will be targeted at indications where point-of-demand testing or decentralized testing can deliver high clinical value at an attractive price point. Our acquisition of intellectual property provides proprietary content that enables a competitive advantage. GMD’s assays for SARS-CoV-2 (COVID-19), Valley Fever, MRSA⁺ and Influenza all fall into this category.
Enabling Smaller Laboratories
Tactical Clinical Tests
These Tactical Clinical Tests are tests that GMD implements on the GeneSTAT® platform to enable smaller laboratories without access to other molecular instruments to offer a broader menu of tests — a key decision factor in instrument acquisition. These tests may or may not be novel, but provide additional value to the platform for smaller laboratories or clinics and support GMD’s proposition of decentralized testing. This will generate additional revenue from each instrument placement, while requiring lower development costs.

More Testing Applications
Tactical Non-clinical Tests
Tactical Non-clinical tests are GMD opportunities that arise from the unique capabilities and characteristics of the GeneSTAT System, which allow it to meet the demand of markets where the instrument needs to go where the testing is being performed. The GeneSTAT can be applied to a variety of market segments, including:
• Human disease surveillance
• Veterinary medicine
• Agriculture
• Food safety
• Food adulteration testing 

These opportunities will be accomplished either through internal development or through a series of Developmental Partner Programs where partners license the technology, fund the development program, and are responsible for the sales channel.

Assays currently under development include: 

MRSA+
This assay is being developed to identify and differentiate resistant and non-resistant strains of Staphylococcus, including MRSA and Coagulase Negative Staphylococcus (CNS). Staphylococcus infections are the most common hospital-acquired or associated infections (HAI). Most of the focus over the past few years has been on MRSA. However, in terms of incidence and total cost, strains of Staphylococcus other than MRSA are a much more common problem.

MERS
MERS is part of the same family of Coronaviruses as COVID-19. Like COVID-19, some laboratory-confirmed cases of MERS-CoV infection are reported as asymptomatic, meaning that they do not have any clinical symptoms, yet they are positive for MERS-CoV infection following a laboratory test. Although most human cases of MERS-CoV infections have been attributed to human-to-human infections, current scientific evidence suggests that dromedary camels are a major reservoir host for MERS-CoV and an animal source of MERS infection in humans.