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DxNA  
 分子診斷公司

DxNA, llc., is a molecular diagnostic company that focuses on simple, rapid and affordable real time PCR technology for users such as clinics, small to medium sized hospitals, doctors’ offices, and others with a need for low throughput or portable PCR diagnostics. To fulfill this objective, DxNA has successfully developed its GeneSTAT? analyzer and its multiplexed test cartridge system. Patents have already been secured for the analyzer, and patents are pending for the proprietary test cartridge. Validation studies were successfully completed by independent laboratories comparing GeneSTAT? assays for 2009 A/H1N1 Influenza and 2010 A/H5N1 influenza. These studies showed the GeneSTAT? system to be comparable in both sensitivity and specificity to the “gold standard” of high throughput lab based PCR systems.

Following the FDA requirements for the manufacturing of medical devices, the company has successfully completed the design and development phase as well as the internal verification of the GeneSTAT platform. DxNA is fully compliant with the Quality System Regulations, has achieved ISO 13485:2003 certification, and has also received notice of the GeneSTAT? analyzer CE mark registration.

DxNA does the final assembly and calibration of the GeneSTAT? analyzer in-house and manufactures the test cartridge assays at its St. George Utah facility.

We are now focused on obtaining FDA 510(k) clearance for the GeneSTAT? analyzer and accompanying assay test cartridges.

History
DxNA, LLC., was established in 2008 as the successor company of Dx Nucleic Analytics, LLC., which was founded in 2005. The Company developed, manufactures, and markets a proprietary Real Time - PCR molecular diagnostic platform under the trademark GeneSTAT?. The platform is comprised of an analyzer and single-use test cartridge.