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

November 15, 2016 7:08 AM EST

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Ignyta, Inc. (Nasdaq: RXDX) 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 NTRK1/2/3, ROS1, or ALK gene fusions.

The CE marking 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.

“We are pleased to obtain both the EAP designation from the FDA and also CE marking for Ignyta’s Trailblaze Pharos assay,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “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. They also demonstrate our commitment to an integrated Rx and Dx approach, working with regulatory agencies to develop robust diagnostic assays and new therapeutic options.”

The FDA EAP program is intended for medical devices that demonstrate the potential to address unmet medical needs for life threatening diseases or conditions, which is analogous to some features of the FDA’s expedited programs for drug reviews.

To achieve CE marking for the Trailblaze Pharos diagnostic assay, Ignyta’s test service demonstrated compliance with specific requirements and conforms to the current EU directive on in vitro diagnostic devices.

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