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HTG Molecular Diagnostics Provides Regulatory Update for its HTG EdgeSeq ALKPlus Assay

TUCSON, Ariz., Sept. 11, 2017 (GLOBE NEWSWIRE) – HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents and services for molecular profiling applications, today announced that it expects to complete and file the fourth and final module related to the premarket approval application (PMA) submission for its HTG EdgeSeq ALKPlus Assay in the second quarter of 2018. The first three modules of the PMA have already been submitted to the U.S. Food and Drug Administration (FDA) for review.

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HTG Molecular Diagnostics Obtains CE Mark for its HTG EdgeSeq ALKPlus Assay EU

TUCSON, Ariz., March 22, 2017 (GLOBE NEWSWIRE) – HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents, and services for molecular profiling applications, today announced that it has obtained CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU.

The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay intended to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer (NSCLC). The assay may be used to aid in the identification of patients eligible for treatment with ALK-targeted therapeutics, such as crizotinib, and is automated on the HTG EdgeSeq system using a next-generation sequencer for detection.

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HTG Molecular Diagnostics Completes Module Three Filing for HTG EdgeSeq ALKPlus Assay PMA

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.

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Page last updated July 23, 2020