DxNA, LLC develops and manufactures high value molecular diagnostic instruments/platforms and tests with an emphasis in the area of infectious diseases. The company’s primary focus is on bringing the benefits of molecular testing to under-served community hospitals and clinics so that diagnostic information is more readily and quickly available. Using this information in a timelier manner has been shown to impact clinical decision making, improve patient outcomes and lower treatment costs. To make molecular testing available to more patients, the company has developed the GeneSTAT® System™ as its first instrument system. This novel, patented and highly portable instrument is combined with a proprietary test cartridge to provide easy to use, rapid and affordable Real-Time PCR molecular testing capabilities that are ideal for low to moderate throughput locations. Examples of target markets for the GeneSTAT System include small to mid-sized community hospitals, clinics, and rural healthcare facilities where high cost & high volume instruments requiring specially trained laboratory technicians are not viable. There has been limited penetration of molecular diagnostics in these market segments to date largely due to the lack of appropriate instrument platforms able to meet their unique needs.
In December 2013 DxNA, LLC acquired a clinical molecular diagnostic test development company- to provide high value test content for use on the GeneSTAT instrument. Through this acquisition DxNA, LLC has acquired a number of novel, proprietary and clinically important diagnostic tests for infectious diseases. These GeneSTAT®.MDx™ tests are currently being implemented and optimized on the GeneSTAT system in preparation for regulatory clearances in the US and Europe. The first FDA cleared test is projected to be launched in the US in Q4-2017. It is anticipated that this combination of a novel high value instrument platform with novel high value tests will lead to a robust pipeline and provide a powerful value proposition in large, underserved markets that have not been well served by current molecular testing instruments.
In addition to clinical diagnostics, the unique characteristics of the GeneSTAT instrument system support molecular testing ANYWHERE, ANYTIME, by ANYONE. This makes the GeneSTAT an ideal platform for many other important markets such as: food safety, veterinary medicine and agriculture. The mobility, flexibility and ease of use are ideal for providing testing information rapidly at the point where it is needed to make critical decisions in all of these potential markets.
Using the GeneSTAT System, DxNA, LLC is poised to become a significant player in the low to moderate throughput molecular diagnostic market. The company is ISO:13485 certified and the GeneSTAT Instrument is CE marked allowing commercialization in the EU countries.