TUCSON, AZ -- (Marketwired) -- 07/02/13 -- HTG Molecular Diagnostics, today announced the availability of two new multiplexed assays for drug and oncology research, coinciding with the successful completion of the first wave of installations of its MDEA award-winning HTG Edge System. The newly-released 47-gene HTG Edge DMPK Assay enables researchers to characterize drug metabolism in pre-clinical studies in accordance with FDA guidance in a rapid, standardized and fully automated format. The company also released the HTG Edge TOA Assay which measures the expression levels of 32 of the most commonly assayed oncogenes in fresh or fixed biological specimens, allowing researchers to obtain insights across multiple cancer pathways simultaneously.
"Multiplexed RNA testing is extremely difficult to do with existing technologies, especially in clinical sample types such as fixed tissues. This issue is best demonstrated today in that the majority of RNA based diagnostics are done in centralized high complexity labs resulting in very expensive tests and long turnaround times for patients. HTG Molecular's mission is to make RNA testing simple, fast and cost effective so all labs can perform this type of testing in a routine manner, resulting in lower costs to our healthcare system and vastly improved turnaround time for doctors and patients," commented TJ Johnson, HTG Molecular Chief Executive Officer. "The HTG Edge System and chemistry were specifically developed to enable a 'walkaway' level of automation that fits seamlessly into standard molecular lab workflows. We are very encouraged by customer response to the HTG Edge System, and the majority of our initial production run has already been allocated."
John Lubniewski, HTG Molecular Chief Business Officer, stated, "The HTG Edge System's architecture will allow a continuous expansion of applications, menu and features with a multi-year roadmap already planned and prioritized. We have held discussions with the FDA as we prepare for our initial submission later this year, and plan CE-marking and Canadian registration prior to 2014."
ABOUT HTG MOLECULAR DIAGNOSTICS:
HTG Molecular Diagnostics is a privately held company providing products for miRNA, and mRNA measurement for translational research/medicine and molecular diagnostics. The company's qNPA molecular technology platform is well-suited for reliably detecting changes in gene expression levels; especially from formalin-fixed, paraffin-embedded (FFPE) tissue and other biological sample types. Additional information is available at www.htgmolecular.com.
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HTG Molecular Diagnostics
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