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FDA Grants Conditional IDE Approval of Signal Genetics' MyPRS

NEW YORK (GenomeWeb) – Signal Genetics today announced conditional approval from the US Food and Drug Administration for its Myeloma Prognostic Risk Signature genetic test for use as entry criteria for a clinical trial to treat high-risk multiple myeloma patients.

The clinical trial will be sponsored by the University of Arkansas for Medical Sciences. Additionally, the FDA required and subsequently conditionally approved an investigational drug exemption for Signal's test in conjunction with an investigational new drug filed by UAMS for a Phase II trial, designed to improve the clinical outcomes of newly diagnosed multiple myeloma patients with gene expression profiling (GEP)-defined high-risk disease. 

The trial will evaluate the safety and efficacy of UAMS' investigational treatment regimen. MyPRS will be used to qualify patients who are considered to have GEP-defined high-risk multiple myeloma. The investigation will take place in a single US site. UAMS is required to provide to the FDA additional information during the next 45 days, though it is allowed to begin enrollment for the trial based upon MyPRS after UAMS has received institutional review board approval and has submitted certification of the IRB approval to the FDA, Signal said. 

According to Signal President and CEO Samuel Riccitelli, the FDA's conditional approval "brings us a step closer to our goal of gaining companion diagnostic status for MyPRS," he said in a statement. 

MyPRS is a microarray-based gene expression profiling assay that predicts the risk of early relapse and enables physicians to stratify their patients and treatment options and to identify genomic alterations that may affect the choice of therapies.