The investment dollars will be used to complete the regulatory processes for the FDA 510(k) clearance of a Valley Fever (Coccidioidomycosis) assay on the GeneSTAT® system. The funding will also be used to initiate the regulatory processes for FDA 510(K) clearance and EEA CE-marking of a next-generation Staphylococcus Diagnostic Test the company calls its MRSA+ Assay.
The GeneSTAT® system is a rapid real-time PCR analyzer and cartridge system that is designed to be a simple to use, point of care system. The system has previously been validated for a CE-mark, which was obtained in 2011.
Valley Fever, called “A Silent Epidemic” by the CDC in a June 2013 article, is endemic to parts of California, Nevada, Utah, New Mexico, and Texas and the entire state of Arizona. As populations in those area increase and as more people travel through those areas, the exposure to and the risk of a significant number of infections is increasing each year. There are currently no FDA cleared PCR-based assays for diagnosing this disease that can be debilitating. Clearing this assay on a rapid, cost effective, point of care device will give the medical practitioner the option to quickly diagnose the symptomatic patient and prescribe appropriate monitoring and treatment before the disease reaches a debilitating stage.
The MRSA+ Assay, as previously mentioned, is a next generation Staphylococcus - assay that will detect and differentiate both Staphylococcus aureus and Coagulase Negative Staphylococcus in a sample and also detect which, if either, has the Methicillin resistant mec-A gene. On the GeneSTAT system this assay will, in about an hour, identify and differentiate infections caused by antibiotic resistant and/or non-resistant types of Staphylococcus thus providing information to the medical practitioner that is critical to treatment decisions that can save lives. This assay, upon regulatory clearance, is expected to be marketed in the United States as well as the EU.
“This funding is allowing us to press forward on the path we have been mapping out since we acquired the rights to both of these assays. This is an exciting time for DxNA, bringing us closer to entering the US and EU diagnostic markets with what we feel are ground breaking and distinguishing products.” says David Taus, CEO of DxNA, llc.
DxNA is a privately held company located in St. George Utah. It is a molecular diagnostics company that develops and distributes portable, fully-integrated systems and tests for infectious disease in the medical, agricultural, food safety, and biosecurity markets. The Company's systems and technologies enable rapid and precise molecular testing to take place on-site by allowing for otherwise complex laboratory procedures to be performed almost anywhere.
DxNA’s patented GeneSTAT® portable Real Time PCR molecular diagnostic testing system will allow individuals with minimal training to conduct accurate real-time diagnostic testing in virtually any location including laboratories, clinics, physician offices, emergency rooms or field settings. Designed with economy in mind, GeneSTAT is inherently less costly than the real time PCR systems typical of clinical laboratories.