FDA approves Trailblaze Pharos RNA-based companion diagnostic for use with entrectinib in solid tumours - Ignyta

Ignyta has announced that the FDA has approved an investigational device exemption for Trailblaze Pharos RNA-based companion diagnostic, next-generation sequencing (NGS) assay. The Trailblaze Pharos assay is intended for use in identifying patients, including those who are treatment-na�ve, who have solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins, to determine eligibility for enrollment into the global STARTRK-2 trial, a Phase II study of entrectinib, a novel, orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1, or ALK gene fusions.

An IDE allows an investigational device, in this case the Trailblaze Pharos assay, to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application submission to FDA. An IDE application is approved only after direct review by the FDA on many aspects of the device validation and how clinical testing will be performed.

Comment:The Trailblaze Pharos assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a sequencing based assay 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. The assay is intended to be used as an aid in selecting patients, including those who are treatment-na�ve, with solid tumors that harbor a gene rearrangement in NTRK1/2/3, ROS1, or ALK, for whom enrollment in the STARTRK-2 study may be appropriate. A laboratory developed test (LDT) version of the Trailblaze Pharos assay was previously used to identify non-treatment-na�ve patients with NTRK1/2/3, ROS1, or ALK gene rearrangements who might be eligible for the STARTRK-2 study.