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FDA Grants IDE Approval for Almac Diagnostic Services' CDx for Use in Cancer Drug Study

NEW YORK (GenomeWeb) – Turning Point Therapeutics and Almac Diagnostic Services today announced approval by the US Food and Drug Administration of an investigational device exemption for use of an Almac diagnostic assay to determine whether cancer patients are eligible to enroll in a Phase II clinical study.

The next-generation sequencing assay is intended for use in identifying patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors and will be used to determine if a patient is eligible to enroll in Turning Point's registrational Phase II portion of the global TRIDENT-1 clinical study.

Almac — based in Craigavon, UK and Durham, North Carolina — has been developing the NGS diagnostic on Archer Dx's Anchored Multiplex PCR (AMP) chemistry with the intention of submitting the assay for regulatory approval in the US and using it initially at Almac's CLIA-accredited laboratory in Durham to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

Athena Countouriotis, president and CEO of Turning Point, said in a statement that achieving the FDA approval with Almac moves it closer to starting a pivotal study for repotrectinib in the second half of 2019. "With a clear unmet medical need for therapies that target genomic alterations in different cancers, the diagnostic assay will provide clinical investigators with timely information to confirm the presence of the oncogenic drivers we continue to study in patients with advanced solid tumors," she said.

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3, or ALK molecular rearrangements.