Ignyta (RXDX) Receivs FDA Approval of IDE for Trailblaze Pharos Assay
- Wall Street falls with financials, other post-election gainers
- The FTC Confirms Antitrust Charges Against Qualcomm (QCOM) for Monopolizing Semiconductor Device Used in Cell Phones
- United Airlines (UAL) Tops Q4 EPS by 5c
- Obama shortens sentence of Manning, who gave secrets to WikiLeaks
- After-Hours Stock Movers 01/17: (SHLO) Higher; (GIMO) (AFAM) (CSX) Lower (more...)
Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here.
Ignyta, Inc. (Nasdaq: RXDX) announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its RNA-based companion diagnostic, next-generation sequencing (NGS) assay (Trailblaze Pharos™). The Trailblaze Pharos assay is intended for use in identifying patients, including those who are treatment-naïve, who have solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins, to determine eligibility for enrollment into the global STARTRK-2 trial, a Phase 2 study of entrectinib, a novel, orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1, or ALK gene fusions.
“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 tumor profiling for these fusions and therefore may never have been identified,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “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.”
An IDE allows an investigational device, in this case the Trailblaze Pharos assay, to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application submission to FDA. An IDE application is approved only after direct review by the FDA on many aspects of the device validation and how clinical testing will be performed.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Jazz Pharmaceuticals (JAZZ) Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating Defibrotide for Prevention of VOD
- Caesars Entertainment (CZR) Announces Confirmation of CEOC's Plan of Reorganization
- Neurocrine Biosciences (NBIX) Reports Results from Phase II Clinical Study of VMAT2 Inhibitor INGREZZA
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!