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.