Ignyta Announces Accreditation of its Diagnostic Laboratory by College of American Pathologists

SAN DIEGO--()--Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced that its San Diego diagnostic laboratory has been accredited by the College of American Pathologists (CAP) based on results of a recent on-site inspection. This accreditation is awarded to facilities that meet the highest standards of quality in clinical laboratory services. With this recognition, Ignyta’s diagnostic laboratory joins the ranks of some of the most prominent clinical laboratories in the world.

“We are extremely proud that our in-house diagnostic laboratory has achieved CAP accreditation, further validating our commitment to provide the highest quality laboratory services as part of our focus on helping healthcare providers take better care of patients suffering from cancer,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “This milestone is consistent with our vision of becoming the world’s leading precision medicine company, with an integrated approach to ‘Rx/Dx’ in oncology. Furthermore, we believe our diagnostic laboratory provides us with a competitive advantage. For example, in our potentially-registration-enabling Phase 2 clinical trial of entrectinib, STARTRK-2, we are using our lab as the FDA-required central lab to confirm the results of local genetic patient screening for enrollment, as well as to perform central testing for clinical sites without the means for local genetic screening to identify patients with molecular alterations eligible for this clinical trial that would otherwise not have been identified.”

The U.S. Centers for Medicare & Medicaid Services (CMS) has approved CAP as an accreditation organization for clinical laboratories under CLIA (Clinical Laboratory Improvement Amendments). Ignyta had previously announced CLIA registration of its diagnostic laboratory, and CAP accreditation results in full CLIA certification for Ignyta’s diagnostic laboratory.

About Ignyta, Inc.

At Ignyta, we fight cancer – a formidable opponent that manifests as thousands of different molecularly defined diseases and takes away millions of lives globally, every year. In this fight, our Big Hairy Audacious Goal (BHAG) is not just to shrink tumors but to eradicate residual disease – the source of cancer relapse and recurrence – in precisely defined patient populations by 2030. We will work tirelessly to achieve this BHAG by pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. Our Rx efforts are focused on discovering, in-licensing or acquiring, then developing and commercializing, molecularly targeted therapies; cancer stem cell/dormant tumor cell targeted therapies; novel chemotherapies/cell cycle inhibitors; and cancer immunotherapies – four therapeutic cornerstones that, sequentially or in combination, are foundational for eradicating residual disease. Our Dx efforts aim to pair these product candidates with biomarker-based companion diagnostics that are designed to precisely identify, at the molecular level, the patients who are most likely to benefit from the monotherapies and polytherapies we develop. We believe that only through this integrated Rx/Dx approach can we succeed in this fight. For more information, please visit: www.ignyta.com.

Forward-Looking Statements

This press release contains forward-looking statements about Ignyta 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 CAP accreditation and operation of Ignyta’s in-house diagnostics laboratory, the ability to use this laboratory to enroll patients in Ignyta’s clinical trials and Ignyta’s ability to help healthcare providers care for cancer patients and become the world’s leading precision medicine company. 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 www.sec.gov, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent Quarterly Reports on Form 10-Q.

Contacts

Ignyta, Inc.
Jacob Chacko, M.D.
CFO
858-255-5959
jc@ignyta.com

Contacts

Ignyta, Inc.
Jacob Chacko, M.D.
CFO
858-255-5959
jc@ignyta.com