US-based biotechnology company Ignyta has secured investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for its RNA-based companion diagnostic, next-generation sequencing (NGS) assay (Trailblaze Pharos).
The Trailblaze Pharos assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a next-generation sequencing (NGS) based assay which has been designed to detect fusions in the NTRK1/2/3, ROS1, or ALK genes in the RNA from formalin-fixed paraffin-embedded (FFPE) human solid tumour tissue.
It will assist in identifying patients for the Studies of Tumor Alterations Responsive to Targeting Receptor Kinases (STARTRK-2) study, including those who are treatment-naïve, with solid tumours that feature a gene rearrangement in NTRK1/2/3, ROS1, or ALK.
The Phase II STARTRK-2 trial will be conducted to test the company’s CNS-penetrant tyrosine kinase inhibitor, entrectinib to target tumours expressing NTRK1/2/3, ROS1, or ALK gene fusions.
Ignyta chairman and CEO 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 tumour 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."
Earlier, a laboratory developed test (LDT) version of the Trailblaze Pharos assay identified non-treatment-naïve patients with NTRK1/2/3, ROS1, or ALK gene rearrangements who was considered eligible for the STARTRK-2 study.