The DxNA LLC pipeline strategy consists of three programs: Strategic Clinical Tests; Tactical Clinical Tests; and Tactical Non-clinical tests. Pipeline development will concentrate on the infectious diseases area.
Strategic Clinical Tests are those tests that 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. The PathoGene acquisition provides proprietary content that enables a competitive advantage. DxNA’s projected first three assays Valley Fever, Influenza and Drug Resistant Staph (MRSA/MRCoNS) all fall in this category.
Tactical Clinical Tests are tests that DxNA implements on the 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 DxNA’s decentralized testing proposition. This will generate additional revenue from each instrument placement while requiring lower development costs.
Tactical Non-clinical Tests are DxNA opportunities that arise from the unique capabilities and characteristics of the GeneSTAT System that meet the needs 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 and food adulteration testing. These opportunities will be either accomplished 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.