Rosetta Genomics Launches Two Assays for Bladder Cancer

Rosetta Genomics Ltd.

, a leading developer and provider of microRNA-based molecular and other diagnostics, announces that the Company will commercially introduce two FGFR3 gene mutation assays; one for diagnostic monitoring using urine samples to detect recurrences of FGFR3-positive low-grade bladder cancers, and the other in conjunction with Ki67 expression for tissue-based prognostication at initial diagnosis of bladder cancer. Both assays will be introduced at the American Urological Association Annual Meeting (AUA 2015) taking place from May 15-19, 2015 in New Orleans. FGFR3 mutation analysis identifies low-grade bladder cancer in both urine- and tissue-based specimens to help urologists better manage patients through improved prognostication and non-invasive recurrence monitoring in urine samples. These assays are used in conjunction with the Company's leading FISH technology to provide highly sensitive and specific assays for all grades of bladder cancer. Multiple prior studies have shown that FGFR3 has the ability to detect a significant number of low-grade bladder tumors as well as tumors in the upper urothelial tract from voided urine specimens. Therefore, FGFR3 may detect tumors that conventional detection methods miss. The FGFR3 mutation analysis is part of the PersonalizeDx product line and addresses a market opportunity of approximately $250 million in the U.S. PersonalizeDx, a Rosetta Genomics company, was acquired by Rosetta Genomics last month. "We are delighted to be initially launching our FGFR3 mutation analysis testing for bladder cancer at AUA 2015 among an audience of the country's leading urologists who diagnose and treat bladder cancer daily. These promising assays are expected to help urologists better understand their patients' bladder cancer and improve their outcomes," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "In addition to FGFR3 in bladder cancer, we are developing a microRNA-based assay for bladder cancer risk of invasiveness. We have completed two studies with this assay and expect to begin additional studies for this indication by the end of the year. We believe these offerings create a broader commercial footprint and expanded product offering in urological oncology diagnostics with numerous products to address unmet needs in bladder, prostate and kidney cancer."