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
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.