Terms of the agreement include upfront and milestone payments as well as ongoing royalties. In addition to the License Agreement, the two companies have agreed to a Letter of Intent under which DxNA would acquire PathoGene. This transaction is expected to occur in the next 6 months, contingent on satisfactory completion of due diligence and other contingencies. Financial terms contained in the LOI were not disclosed.
Pathogene’s next generation Staphylococcus assay is clearly differentiated from current commercially available MRSA assays in that it provides rapid identification and drug resistance information for Staphylococcus infections, one of the most common hospital acquired infections. In combination with the GeneSTAT platform, this capability can be delivered to almost any healthcare setting due to its portability and “point of care” design. “In addition to testing for MRSA, Pathogene’s assay also detects multi-drug resistant Coagulase Negative Staphylococcus strains, which are actually much more common infections than MRSA. This is a significant step forward compared to current diagnostic methods and allows the assay to rapidly identify and differentiate three of the most common pathogens of hospital acquired infections – surgical site infections, medical device infections and skin and soft tissue infections – in a single multiplexed assay. This provides information to physicians in about an hour that is critical to treatment decisions that save lives, improve patient outcomes and reduce treatment costs.” said Todd Snowden, PathoGene President and CEO.
”Pathogene’s novel approach with this Staph assay provides rapid clinical answers that impact patient care, costs and outcomes making the assay an ideal complement to our GeneSTAT platform. The use of the assay for diagnostics represents a combined $650M market opportunity in the US and the EU”, said David Taus, DxNA President and CEO.
DxNA’s Real Time PCR GeneSTAT platform for molecular diagnostic infectious disease testing is uniquely postioned to meet the on-site Staph diagnostic testing needs of Hospitals, Point of Care, Long Term Care and Urgent Care Centers. The GeneSTAT analyzer with the Staph multiplexed test cartridge provides the performance, ease of use, speed, portability and economics required for Staph diagnostic testing to be broadly adopted in these clinical settings.
DxNA LLC is a privately owned Limited Liability Company located in St. George, Utah. DxNA develops and commercially manufactures molecular-based diagnostic assays formatted in a unique and proprietary test cartridge designed for analysis by its proprietary GeneSTAT® analyzer. The test cartridges, together with the GeneSTAT analyzer make up DxNA’s proprietary GeneSTAT® Platform. The current assays are both DNA- and/or RNA-based “multiplexed” tests for “real time” detection of infectious disease agents in humans, and animals or of biological contaminants in the environment. DxNA combines proprietary intellectual property with industry proven technology into the GeneSTAT Platform that the Company believes to be unique in the industry. The GeneSTAT offers unmatched simplicity and control in the processing of specimens. The Platform is comprised of an analyzer and a single-use test cartridge, and can be run with minimal training in either laboratory or field settings accepting a number of specimen types.