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Ignyta CDx Receives FDA Investigational Device Exemption

NEW YORK (GenomeWeb) – Biotechnology company Ignyta announced today that it has received an investigational device exemption (IDE) from the US Food and Drug Administration for its RNA-based companion diagnostic Trailblaze Pharos.

The diagnostic is a next-generation sequencing-based assay and will be used to identify patients with solid tumors with NTRK1, NTRK2, NTRK3, ROS1, or ALK gene rearrangements leading to fusion proteins. Ignyta plans to enroll such patients into its global STARTRK-2 trial, a Phase II study of an investigational drug the company is developing called entrectinib. The therapy is a CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1, NTRK2, NTRK3 gene fusions encoding TrkA, TrkB, or TrkC, or tumors with ROS1 or ALK gene fusions.

The IDE will allow the company to use the Trailblaze Pharos assay in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application submission to the FDA for entrectinib.

"We are pleased to have been granted this IDE approval for our investigational companion diagnostic assay, as it allows us to screen potential patients for STARTRK-2 who might not otherwise have access to tumor profiling for these fusions and therefore may never have been identified," said Ignyta Chairman and CEO Jonathan Lim in a statement. "We look forward to continuing to work with the FDA on developing and providing a robust assay to help physicians identify cancer patients who may be eligible for our clinical studies."