HTG Molecular Diagnostics Completes Module Three Filing for HTG EdgeSeq ALKPlus Assay PMA
January 05, 2017 at 09:01 pm
HTG Molecular Diagnostics, Inc. 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.