FDAnews Device Daily Bulletin

FDA Clears Genomic Assay for Cancer Trial

Sept. 2, 2016

The FDA approved an investigational device exemption for Ignyta’s Trailblaze Pharos assay for use in identifying patients, including those who are treatment-naïve, with solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins.

The RNA-based companion diagnostic will be used to determine enrollment eligibility for the STARTRK-2 trial, a global Phase II study evaluating entrectinib in multiple tumors.

A laboratory-developed test version was previously used to identify non-treatment-naïve patients who might be eligible for the study. — Conor Hale

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