Ignyta Announces the Release for Clinical Use of a Proprietary NGS Clinical Trial Assay to Support Its STARTRK Clinical Studies

On June 30, 2015 Ignyta reported the release for clinical use of its first clinical trial assay to support patient identification and enrollment into its STARTRK ("Studies of Tumor Alterations Responsive to Targeting Receptor Kinases") clinical development program for entrectinib (Press release, Ignyta, JUN 30, 2015, View Source [SID:1234506011]). Entrectinib is the company’s proprietary oral tyrosine kinase inhibitor, targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK.

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"A key tenet of Ignyta’s vision to be a leading precision oncology company is our ability to seamlessly integrate Rx with Dx to detect appropriate cancer patients to treat with highly targeted agents," said Jonathan Lim, M.D., Ignyta’s Chairman and Chief Executive Officer. "Today we have taken a major step toward achieving that vision by releasing for clinical use Ignyta’s first clinical trial assay, which was co-developed with ArcherDx and validated within Ignyta’s own diagnostic labs. Ignyta’s CLIA-registered, QSR-compliant diagnostic lab in San Diego will utilize this assay in acting as the central testing lab for patient screening for the STARTRK-2 study."

STARTRK-2 is a global Phase 2 study that will further evaluate the safety and efficacy of entrectinib, and the design was recently summarized at Ignyta’s Management Presentation during the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference.

The NGS-based clinical trial assay will initially be performed only to identify potential patients for clinical trial enrollment and will not be offered for commercial use.