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
Strategic Clinical Tests — Meeting Unmet Needs
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.
Tactical Clinical Tests — Enabling Smaller Laboratories
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.
Tactical Non-clinical Tests — More Testing Applications
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
- 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.