Ignyta has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Trailblaze Pharos RNA-based companion diagnostic and next-generation sequencing (NGS) assay.
The approval has been granted to identify patients, including those who are treatment-naïve and who have solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins.
The assay will be used for the qualitative detection of fusions in the NTRK1/2/3, ROS1, or ALK genes in the RNA from formalin-fixed paraffin-embedded (FFPE) human solid tumor tissue.
It will help to determine eligibility for enrollment into the global STARTRK-2 trial, a Phase 2 study of entrectinib.
Entrectinib is a novel and orally available CNS-penetrant tyrosine kinase inhibitor, which targets targeting tumors that harbor NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1, or ALK gene fusions.
Earlier, Trailblaze Pharos assay’s laboratory developed test (LDT) version has been used to identify non-treatment-naïve patients with NTRK1/2/3, ROS1, or ALK gene rearrangements who might be eligible for the STARTRK-2 study.
Ignyta chairman and CEO Dr Jonathan Lim said: "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.
"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."