Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Videos
Diagnostics
In Vitro Diagnostics
Return to: MDBR Home | Diagnostics | In Vitro Diagnostics

Ignyta gets FDA EAP status and CE mark for Trailblaze Pharos clinical trial assay

MDBR Staff Writer Published 16 November 2016

Biotechnology company Ignyta has secured CE mark approval and Expedited Access Pathway (EAP) status from the US Food and Drug Administration (FDA) for its Trailblaze Pharos companion diagnostic test.

The Trailblaze Pharos assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a next generation sequencing (NGS) based test 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 EAP status allows Ignyta to conduct more interactive discussions of the premarket approval application (PMA) for Trailblaze Pharos, which is the proposed companion diagnostic for entrectinib.

Entrectinib is the firm’s investigational and orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions.

The CE mark approval has been granted for the assay to be used in identifying patients who have solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins

It is provided as a no-cost test across the globe to determine eligibility for enrollment into the STARTRK-2 trial, a global phase 2 clinical basket study of entrectinib.

Trailblaze Pharos assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a next generation sequencing (NGS) based test 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.

Ignyta chairman and CEO Jonathan Lim said: “We are pleased to obtain both the EAP designation from the FDA and also CE marking for Ignyta’s Trailblaze Pharos assay.

“These important milestones exemplify our strong global commitment to help identify patients with actionable TRK, ROS1 and ALK fusions and to provide them a treatment option through the STARTRK-2 clinical trial of entrectinib.”