Signal Genetics receives conditional approval of investigational device exemption

Feb. 2, 2015

Signal Genetics, Inc., a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, recently announced the U.S. Federal Drug Administration (FDA) conditionally approved its proprietary prognostic genetic test, MyPRS (Myeloma Prognostic Risk Signature), for use as entry criteria for an upcoming clinical trial to treat high-risk multiple myeloma (MM) patients sponsored by the University of Arkansas for Medical Sciences (UAMS).

The FDA required and subsequently conditionally approved an investigational drug exemption (IDE) for Signal's prognostic test in conjunction with an investigational new drug (IND) filed by UAMS for its “2012-02 Total Therapy 5B: A Phase II Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (AS-CR) By Applying Non-Host-Exhausting and Timely Dose-Reduced MEL-80-CFZ-TD-PACE Transplant(s) with Interspersed MEL-20-CFZ-TD-PACE with CFZ-RD and CFZ-D Maintenance” designed to improve clinical outcomes of newly diagnosed MM patients with gene expression profiling (GEP) defined high-risk disease.

The Phase II trial will assess safety and efficacy for the investigational treatment regimen, using MyPRS to qualify which patients are considered to have GEP defined high risk MM. The investigation is limited to a single testing site in the United States and 45 subjects enrolled (approximately 60 subjects screened and 14 subjects enrolled per year). The conditional approval requires UAMS to provide the FDA with further information over the next 45 days; however, UAMS is allowed to begin enrollment of the trial based upon MyPRS immediately after UAMS has obtained institutional review board (IRB) approval and submitted certification of IRB approval to FDA.

Learn more about the MyPRS on the Signal Genetics website