SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced that its San Diego diagnostic laboratory successfully passed the State of California survey for CLIA (Clinical Laboratory Improvement Amendments) certification. The State of California inspector granted Ignyta permission to begin offering molecular diagnostic services to patients, including those in the company’s clinical trials.
“Achieving CLIA certification of an in-house diagnostic laboratory is an exceptionally rare event for a therapeutically focused biotechnology company – and a landmark milestone for Ignyta, where we believe an integrated Rx/Dx approach provides us with the best means of serving our patients in precision oncology,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “We can now use our CLIA lab to screen patients for enrollment in clinical trials of RXDX-101, as well as any future clinical-stage product candidates, and to perform commercial companion diagnostic testing should RXDX-101 or any of our other product candidates receive FDA approval. I would like to commend our diagnostics team on accomplishing this, especially within such a rapid timeframe to be able to support the Phase IIa portion of our STARTRK-1 clinical trial.”
About Ignyta, Inc.
Ignyta, Inc., located in San Diego, California, is a precision oncology biotechnology company pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. The company’s goal with this Rx/Dx approach is to discover, develop and commercialize new drugs that target activated cancer genes and pathways for the customized treatment of cancer. It aims to achieve this goal by pairing each of its product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients who are most likely to benefit from the precisely targeted drugs the company develops. For more information, please visit: www.ignyta.com.
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 company’s use of its CLIA-certified laboratory, including to support its clinical trials; the potential for RXDX-101 or any other product candidate to receive FDA approval; and the potential for the CLIA-certified laboratory to successfully serve cancer patients. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the potential for the company to fail to maintain the CLIA certification of its diagnostic laboratory or to fail to achieve full CLIA registration of such laboratory; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; regulatory developments in the United States and foreign countries; Ignyta’s ability to develop, 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 Phase I/II clinical trials of RXDX-101, or any future clinical trials, to differ from preliminary results; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates, including reliance on Nerviano for the prosecution and maintenance of certain key intellectual property for all of Ignyta’s in-licensed product candidates; 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, 2013 and subsequent Quarterly Reports on Form 10-Q.