TUCSON, Ariz., Jan. 05, 2017 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (“HTG”), a provider of instruments and reagents for molecular profiling applications, today announced that it has submitted to the FDA the third of four expected modules for the Company’s Pre-Market Approval (PMA) application for the HTG EdgeSeq ALKPlus Assay to be used as a companion diagnostic for Crizotinib.
The third PMA module included data from analytical performance studies completed at HTG along with inter-lab reproducibility study data completed at three trial sites.
“We are very pleased to meet this milestone for the HTG EdgeSeq ALKPlus Assay PMA submission,” stated TJ Johnson, President and CEO of HTG Molecular Diagnostics. “This module three submission was a significant undertaking for the HTG team, and we are now fully focused on completing the fourth and final PMA module early in 2017.”
Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013 the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG's proprietary nuclease protection chemistry. HTG’s product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.
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CONTACT: Contact: Westwicke Partners Jamar Ismail Phone: 415-513-1282 Email: firstname.lastname@example.org TJ Johnson President / CEO HTG Molecular Diagnostics Phone: 520-547-2827 x130 Email: email@example.com