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Home » FDA Clears Genomic Assay for Cancer Trial
FDA Clears Genomic Assay for Cancer Trial
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September 1, 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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