Ignyta (RXDX) Receives EAP Designation, CE Mark for Trailblaze Pharos Diagnostic Test Service

Ignyta, Inc. announced that it has received Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration (FDA) and also “European Conformity” (CE) marking for its Trailblaze Pharos companion diagnostic test service. The EAP designation enables Ignyta and FDA to have more interactive discussions of the premarket approval application (PMA) for Trailblaze Pharos, which is the proposed companion diagnostic for entrectinib, the company’s investigational, orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3ROS1, or ALK gene fusions.

The CE marking certification signifies that Trailblaze Pharos conforms to the European Union (EU) Product Directives, and allows Trailblaze Pharos to be marketed throughout the European Economic Area. The Trailblaze Pharos assay is intended for use in identifying patients who have solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins, and is offered globally as a no-cost test to determine eligibility for enrollment into the STARTRK-2 trial, a global phase 2 clinical basket study of entrectinib.