GeneSTAT Molecular Diagnostics, LLC (GMD) 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 emerging diseases and unique applications, 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 reduce treatment costs.
To make molecular testing available to more patients, the company developed its first instrument, the GeneSTAT® 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 and 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. Since then, GeneSTAT has created a 96-well test cartridge for simple and efficient molecular testing at higher volumes.
In October 2019, GMD 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. GeneSTAT’s first FDA-cleared test was the GeneSTAT.MDxCoccidioides (Valley Fever) molecular test, used with the GeneSTAT instrument. It is anticipated that this combination of a novel, high-value instrument platform with novel, high-value tests will enable GeneSTAT to provide markets of varying sizes with accurate and efficient molecular testing.
In addition to clinical diagnostics, GeneSTAT is an ideal platform for many other important markets such as: food safety, veterinary medicine and agriculture. Its mobility, flexibility and ease of use are ideal for providing rapid testing information at the point where it is most needed, to enable critical decisions in all these potential markets.
GeneSTAT is poised to become a significant player in the molecular diagnostic market. The company is ISO:13485 certified and the GeneSTAT Instrument is CE marked, allowing commercialization in the EU countries.