Rosetta Genomics has launched two new fibroblast growth factor receptor 3 (FGFR3) gene mutation assays for bladder cancer at the ongoing American Urological Association Annual Meeting (AUA 2015) in New Orleans, Louisiana, US.
The first diagnostic monitoring assay will use urine samples to detect recurrences of FGFR3 positive low-grade bladder cancers, while the other will be used in conjunction with Ki67 expression for tissue-based prognostication at initial diagnosis of bladder cancer.
Both assays are expected to be used along with the company's FISH technology to provide highly sensitive and specific assays for all grades of bladder cancer.
The 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.
Rosetta Genomics president Kenneth Berlin said: "These promising assays are expected to help urologists better understand their patients' bladder cancer and improve their outcomes.
"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."
Multiple studies conducted earlier with the FGFR3 indicated that protein can detect a significant number of low-grade bladder tumours, as well as tumours in the upper urothelial tract from voided urine specimens.
FGFR3 may detect tumours that cannot be found by legacy detection methods. The FGFR3 mutation analysis is part of the company's PersonalizeDx product line and addresses a market opportunity of nearly $250m in the US.
Bladder cancer primarily arises from the epithelial lining of the urinary bladder, and is caused due to mutations of HRAS, KRAS2, RB1, and FGFR3 genes.
According to American Cancer Society, approximately 75,000 new cases of bladder cancer are diagnosed in the US every year, with 16,000 deaths.