By Ron Shinkman, Editor, Laboratory Industry Report
Rosetta Genomics has announced two new molecular tests for detecting bladder cancer.
Both urine-based tests focus on mutations within the FGFR3 gene. One test performs monitoring in order to determine if there have been recurrences of a prior bladder cancer. The other works in conjunction with the Ki67 expression of FGFR3 to provide a prognosis and potential treatment pathways for a patient initially diagnosed with bladder cancer. Both tests are being used in conjunction with FISH technology to improve sensitivity.
About 74,000 new cases of bladder cancer are diagnosed in the U.S. every year. About 16,000 patients die from the disease annually. The five-year survival rates when caught early in the progress of the disease are nearly 100 percent, but it drops steadily after the first stage of progression.
The New Jersey-based Rosetta will market the new assays under its PersonalizeDX product line. The company had previously developed molecular tests for the detection and evaluation of lung cancer and kidney cancer.
“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,” said Kenneth A. Berlin, Rosetta Genomics’ chief executive officer, in a statement. “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.”