Company Update (NASDAQ:RXDX): Ignyta Inc Announces Approval of an Investigational Device Exemption (IDE) for the Companion Diagnostic Assay to the STARTRK-2 Trial


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. (Original Source)

Shares of Ignyta are up nearly 7% to $6.00 in pre-market trading. RXDX has a 1-year high of $18.19 and a 1-year low of $4.63. The stock’s 50-day moving average is $5.65 and its 200-day moving average is $6.39.

On the ratings front, Ignyta has been the subject of a number of recent research reports. In a report issued on August 16, J.P. Morgan analyst Anupam Rama maintained a Buy rating on RXDX, with a price target of $15, which represents a potential upside of 168.3% from where the stock is currently trading. Separately, on August 9, Jefferies Co.’s Gena Wang reiterated a Buy rating on the stock and has a price target of $20.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Anupam Rama and Gena Wang have a total average return of 0.6% and -9.2% respectively. Rama has a success rate of 52% and is ranked #2275 out of 4129 analysts, while Wang has a success rate of 34% and is ranked #3864.

The street is mostly Bullish on RXDX stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $13.00, which represents a potential upside of 132.6% from where the stock is currently trading.

Ignyta, Inc. is a precision oncology biotechnology company. It engages in the discovering, acquiring, developing and commercializing targeted new drugs for cancer patients. Currently, the company’s development plans focus on two product candidates: entrectinib, a tyrosine kinase inhibitor directed to the Trk family tyrosine kinase receptors ROS1 and ALK proteins, which is in two Phase I/II clinical studies in molecularly defined patient populations for the treatment of solid tumors; and RXDX-103, a development program targeting the cell division cycle 7-related, or CDC7, protein kinase. 


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