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Press Release

Ignyta Announces Approval of an Investigational Device Exemption (IDE) for the Companion Diagnostic Assay to the STARTRK-2 Trial

Posted on: 31 Aug 16

Ignyta, Inc. (Nasdaq: RXDX),a biotechnology company focused on precision medicine in oncology, today 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.

About Trailblaze Pharos

The Trailblaze Pharos™ assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a next-generation sequencing (NGS) based assay 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 assay is intended to be used as an aid in selecting patients, including those who are treatment-naïve, with solid tumors that harbor a gene rearrangement in NTRK1/2/3, ROS1, or ALK, for whom enrollment in the STARTRK-2 study may be appropriate. A laboratory developed test (LDT) version of the Trailblaze Pharos assay was previously used to identify non-treatment-naïve patients with NTRK1/2/3, ROS1, or ALK gene rearrangements who might be eligible for the STARTRK-2 study.

About Entrectinib

Entrectinib is a novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1, or ALK. Entrectinib is the most potent Trk inhibitor in the clinic, without undesirable off-target activity, and the only Trk inhibitor with clinically demonstrated activity against primary and metastatic CNS disease. This product candidate is in a Phase 2 clinical trial called STARTRK-2, which is the second of the “Studies of Tumor Alterations Responsive to Targeting Receptor Kinases.” The trial is a global, multicenter, open label, potentially registration-enabling Phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib’s demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.

About Ignyta, Inc.

At Ignyta, we work tirelessly on behalf of cancer patients to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by companion diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular drivers of cancer and quickly advancing treatments to address them. This unique approach embraces even those patients with the rarest cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. We are blazing a new future for cancer patients with our pipeline of first-in-class and best-in-class precision medicines – with the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations.

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Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the Trailblaze Pharos assay resulting in enrollment of patients in Ignyta clinical trials and Ignyta’s ability to successfully conduct clinical trials for its product candidates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta’s plans to develop and commercialize its product candidates; the potential for final results of the ongoing clinical trials of entrectinib or other product candidates, or any future clinical trials of entrectinib or other product candidates, to differ from preliminary or expected results; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the potential for the company to fail to maintain the CAP accreditation and CLIA certification of its diagnostic laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent Quarterly Reports on Form 10-Q.

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Last updated on: 31/08/2016

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