HTG Molecular Diagnostics to Complete FDA Filing for Gene Assay

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HTG, a company that provides molecular profiling services, expects to complete submission of its premarket approval application to FDA for an in vitro gene assay by 2018.

HTG Molecular Diagnostics, a provider of instruments, reagents, and services for molecular profiling applications, announced on Sep. 11, 2017 that it expects to complete and file a fourth and final module in the second quarter of 2018 related to its premarket approval application (PMA) submission to FDA for its HTG EdgeSeq ALKPlus Assay. The company had submitted the first three modules of the PMA earlier for FDA review.

The assay is an in vitro diagnostic 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. This assay may aid the identification of patients eligible for ALK-targeted therapeutics, such as crizotinib, and is automated on the HTG EdgeSeq system using a next-generation sequencer for detection. 

“To date, FDA has completed its review of the first two of the three submitted modules and is currently reviewing the third module,” said TJ Johnson, CEO of HTG, in a company press release. “Following collaborative discussions with FDA, we have finalized plans to conduct a method comparison study needed to complete and file the fourth and final module. We anticipate completing this study in the first quarter of 2018 and submitting the final PMA module in the second quarter of 2018. Importantly, we believe our commercialization efforts with the HTG EdgeSeq ALKPlus Assay EU, our CE/IVD marked product in Europe, are going well, and we intend to launch the HTG EdgeSeq ALKPlus Assay in the US once we receive PMA approval.”


Source: HTG Molecular Diagnostics