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Almac NGS-Based CDx Gets CE Mark

NEW YORK (GenomeWeb) – Almac Diagnostic Services today announced that it has received CE marking for a next-generation sequencing-based diagnostic assay that will be used to determine molecular eligibility for enrolling patients in a pivotal Phase 2 portion of a cancer drug clinical trial.

The assay — which identifies patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors — will be used in Turning Point Therapeutics' TRIDENT-1 clinical study of repotrectinib (TPX-0005), an investigational, next-generation tyrosine kinase inhibitor being developed for the treatment of patients with advanced solid tumors harboring molecular rearrangements in the three genes.

Receipt of CE marking is further evidence of the utility of the test to support the European portion of the global clinical study, said Almac, which is based in Craigavon, UK and Durham, North Carolina.

The regulatory approval "provides quality assurance of the assay’s analytical performance and demonstrates that the product meets the essential requirements of the European In Vitro Diagnostic Directive 98/79/EC for its intended use," Stewart McWilliams, global VP of quality and regulatory affairs at Almac, said in a statement.

CE marking comes on the heels of the US Food and Drug Administration’s investigational device exemption approval of the assay.

Turning Point Therapeutics anticipates starting its TRIDENT-1 Phase II open-label, multi-cohort study in the second half of 2019.