Ignyta Announces CLIA Certification Achieved By Its Diagnostic Laboratory

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.”