Press Releases


DxNA, LLC Announces the FDA Clearance of the GeneSTAT.MDx™ Coccidioides Test on the GeneSTAT® Analyzer
DxNA, LLC receives a de novo regulatory clearance by the FDA for the GeneSTAT.MDx™ Coccidioides Test on the GeneSTAT® Analyzer – the only FDA cleared molecular test for Valley Fever
DxNA, LLC and Gulf Bio Analytical Announce International Distribution Agreement
International distribution agreement is for DxNA’s GeneSTAT® System and HaFYS™ Pork DNA Detection Assay
DxNA, LLC Announces 510(K) Submission of the GeneSTAT® Analyzer and GeneSTAT® Coccidioides Assay
Precision test backed by expertise of Valley Fever Center for Excellence; incorporates technology developed by TGen.
DxNA,LLC announces the successful completion of multicenter clinical trials of the GeneSTAT® and the Valley Fever Assay
DxNA, LLC announces the successful completion of the GeneSTAT® and Pathogene® Valley Fever Assay multicenter clinical trial.
Advanced drug resistant staphylococcus detection technology licensed to DxNA,llc receives first patent approval.
DxNA,LLC announces the first patent approval for it’s exclusively licensed advanced drug resistant staph detection technology.
DxNA, LLC begins GeneSTAT® and Valley Fever Clinical Trials.
DxNA,LLC announces the commencement of GeneSTAT® and Valley Fever Assay multicenter clinical trials.
DxNA, LLC receives cartridge patent in China.
DxNA, LLC announces that it has received a patent in China for its Sample-to-Result molecular diagnostic test cartridge.
DxNA, LLC launches the HaFYS™ Porcine DNA Detection Assay on the GeneSTAT.
DxNA, LLC announces the launching of the GeneSTAT and HaFYS Porcine DNA Detection Assay at the 6th Penang International Halal Expo and Conference
DxNA, LLC announces the conclusion of the acquisition of PathoGene, LLC
DxNA, LLC has concluded the acquisition of PathoGene, LLC DxNA will implement PathoGene’s Valley Fever and Staphylococcus, among others, on their GeneSTAT system
DxNA, LLC announces new equity funding
DxNA has recieved $2.5 million in new equity funding. The funds will be used to proceded with the regulatory processes to obtain 510(k) clearance for DxNA’s Valley Fever and MRSA+ assays.
DxNA, LLC and PathoGene, LLC complete Staph MRSA+ Assay License Agreement and Sign Letter of Intent for Acquisition
DxNA, LLC and PathoGene, LLC have completed and signed the Staphylococcus Assay License Agreement and announce that a Letter of Intent for DxNA to acquire PathoGene has been agreed to and signed.
DxNA,LLC Acquires Exclusive Licence for PathoGene, LLC’s NextGen Staph-MRSA+ Assay
DxNA, LLC and PathoGene, LLC have signed a Licence Agreement term sheet that gives DxNA exclusive rights for the unit dose platform applications of PathoGene’s NextGen multiplexed Staphylococcus MRSA+ assay. The assay will run on DxNA’s real time PCR GeneSTAT analyzer
BSI America Issues DxNA, LLC an ISO 13485:2003 Recertification
DxNA efforts to comply with it’s Quality Management System is rewarded with an ISO 13485:2003 recertification.
DxNA, LLC Announces Enhancement to its GeneSTAT® System
DxNA, LLC with its ongoing, continuous improvement program, is pleased to announce an enhancement to its GeneSTAT® real time molecular diagnostic cartridge and analyzer system.
DxNA, LLC and Blue Rock Consulting in Beijing, China sign Consulting Agreement 
DxNA, LLC and Blue Rock Consulting announce the signing of a consulting agreement in which Blue Rock Consulting will assist DxNA, LLC with entry into the Chinese market with regards to their GeneSTAT® system.
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