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.

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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.

"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."

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.

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"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."

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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.