January 2, 2014
Saint George, UT
DxNA, LLC announced today the completion of their acquisition of PathoGene, LLC. PathoGene’s founders are the developers of molecular diagnostic tests for infectious diseases such as Valley Fever and drug resistant forms of Staphylococcus, including MRSA, among others..
As a result of this acquisition, DxNA will be implementing these PathoGene tests on its leading edge testing platform, the GeneSTAT® System, along with other tests developed at DxNA. The GeneSTAT® System is a proprietary rapid real-time PCR analyzer and cartridge system that is designed to be a simple, point of use system. The analyzer was CE-marked in 2011.
DxNA plans to take both the Valley Fever test and the Staphylococcus test through the FDA 510(k) regulatory process in 2014. In addition they will be moving the Staphylococcus test through the CE marking process in 2014, as well.
“Our acquisition of PathoGene represents a significant milestone towards differentiating DxNA in both the US and the EU clinical diagnostic markets. Both their Valley Fever test and their Staphylococcus test represent a significant technical advance over currently available diagnostic tests for these infections. When we implement them on the GeneSTAT platform, they will represent a highly differentiated, as well as, a high value offering to the clinical diagnostic market,” reports David Taus, CEO of DxNA,llc.
“The acquisition of PathoGene by DxNA represents a tremendous opportunity to bring current and future PathoGene assays to the clinical market on a platform that we believe will be an important tool in bringing the advantages of molecular testing to smaller community hospitals and closer to the patient, improving the timeliness of diagnostic driven decisions, “stated Todd Snowden, CEO of PathoGene.
Due to the lack of a rapid and accurate diagnostic test, Valley Fever is often misdiagnosed as pneumonia or not diagnosed until after an extended period of illness. This leads to more severe complications and higher treatment costs. With the increase in population and exposure to the Valley Fever fungus in endemic areas of the country, having a rapid, accurate, FDA-cleared assay on an easy-to-use platform will provide a key diagnostic tool for clinicians in making a differential diagnosis in patients who present with symptoms that are consistent with a number of respiratory conditions. This in turn will provide a definitive laboratory test result leading to an accurate diagnosis so that appropriate treatment can be prescribed from the onset of illness.
While MRSA is the most commonly discussed drug resistant form of Staphylococcus, it is actually the other drug resistant Staphylococcal infections that are more commonly found in the hospital environment. This is particularly true of infections associated with medical devices, surgical sites, and skin and soft tissue. Unlike other currently available tests that exclusively identify MRSA alone, the PathoGene MRSA+ test rapidly identifies and differentiates these other more common drug resistant Staphylococcal infections. This information is key to initiating the most effective treatment for these infections and to minimizing treatment costs. When implemented on the GeneSTAT system the test will identify and differentiate between both drug resistant and non-drug resistant Staphylococcus strains in about 1 hour, facilitating early and effective treatment.
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.