GeneSTATMolecularDiagnostics,LLC 435-635-5553 info@genestatmdx.com

Press Releases

12/06/2017
GeneTec, LLC Announces the FDA Clearance of the GeneSTAT.MDx™ Coccidioides Test on the GeneSTAT® Analyzer
GeneTec, 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
08/07/2017
GeneTec, LLC and Gulf Bio Analytical Announce International Distribution Agreement
International distribution agreement is for GeneTec’s GeneSTAT® System and HaFYS™ Pork DNA Detection Assay
07/10/2017
GeneTec, 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.
08/13/2016
GeneTec,LLC announces the successful completion of multicenter clinical trials of the GeneSTAT® and the Valley Fever Assay
GeneTec, LLC announces the successful completion of the GeneSTAT® and Pathogene® Valley Fever Assay multicenter clinical trial.
07/07/2016
Advanced drug resistant staphylococcus detection technology licensed to GeneTec,llc receives first patent approval.
GeneTec,LLC announces the first patent approval for it’s exclusively licensed advanced drug resistant staph detection technology.
08/13/2015
GeneTec, LLC begins GeneSTAT® and Valley Fever Clinical Trials.
GeneTec,LLC announces the commencement of GeneSTAT® and Valley Fever Assay multicenter clinical trials.
05/25/2015
GeneTec, LLC receives cartridge patent in China.
GeneTec, LLC announces that it has received a patent in China for its Sample-to-Result molecular diagnostic test cartridge.
02/11/2015
GeneTec, LLC launches the HaFYS™ Porcine DNA Detection Assay on the GeneSTAT.
GeneTec, LLC announces the launching of the GeneSTAT and HaFYS Porcine DNA Detection Assay at the 6th Penang International Halal Expo and Conference
01/02/2014
GeneTec, LLC announces the conclusion of the acquisition of PathoGene, LLC
GeneTec, LLC has concluded the acquisition of PathoGene, LLC GeneTec will implement PathoGene’s Valley Fever and Staphylococcus, among others, on their GeneSTAT system
11/19/2013
GeneTec, LLC announces new equity funding
GeneTec 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 GeneTec’s Valley Fever and MRSA+ assays.
7/15/2013
GeneTec, LLC and PathoGene, LLC complete Staph MRSA+ Assay License Agreement and Sign Letter of Intent for Acquisition
GeneTec, LLC and PathoGene, LLC have completed and signed the Staphylococcus Assay License Agreement and announce that a Letter of Intent for GeneTec to acquire PathoGene has been agreed to and signed.
5/8/2013
GeneTec,LLC Acquires Exclusive Licence for PathoGene, LLC’s NextGen Staph-MRSA+ Assay
GeneTec, LLC and PathoGene, LLC have signed a Licence Agreement term sheet that gives GeneTec exclusive rights for the unit dose platform applications of PathoGene’s NextGen multiplexed Staphylococcus MRSA+ assay. The assay will run on GeneTec’s real time PCR GeneSTAT analyzer
3/21/2013
BSI America Issues GeneTec, LLC an ISO 13485:2003 Recertification
GeneTec efforts to comply with it’s Quality Management System is rewarded with an ISO 13485:2003 recertification.
1/04/2013
GeneTec, LLC Announces Enhancement to its GeneSTAT® System
GeneTec, LLC with its ongoing, continuous improvement program, is pleased to announce an enhancement to its GeneSTAT® real time molecular diagnostic cartridge and analyzer system.
6/16/2012
GeneTec, LLC and Blue Rock Consulting in Beijing, China sign Consulting Agreement 
GeneTec, LLC and Blue Rock Consulting announce the signing of a consulting agreement in which Blue Rock Consulting will assist GeneTec, LLC with entry into the Chinese market with regards to their GeneSTAT® system.