Rosetta Genomics Launches Two Assays for Bladder Cancer
May 14 2015 - 8:48AM
Business Wire
FGFR3 biomarker assays for disease monitoring
and predicting patient outcomes using both urine- and tissue-based
testing
Rosetta Genomics Ltd. (NASDAQ: ROSG), 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.”
About Bladder Cancer
Some 75,000 new cases of bladder cancer are diagnosed in the
U.S. every year, according to the American Cancer Society, with
approximately 16,000 deaths. Most patients with clinically
localized bladder cancer (stages 0-2) can be treated successfully
with surgery and chemotherapy. Nine in ten patients with stage 1
bladder cancer live five years or longer and more than 500,000
people in the U.S. are bladder cancer survivors.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic
testing services offered by Rosetta Genomics. The Rosetta Cancer
Origin Test™ can accurately identify the primary tumor type in
primary and metastatic cancer including cancer of unknown or
uncertain primary (CUP). The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately
classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and
oncocytoma. Rosetta’s assays are designed to provide objective
diagnostic data. In the U.S. alone, Rosetta Genomics estimates that
200,000 patients a year may benefit from the Rosetta Cancer Origin
Test™, 62,000 from the Rosetta Kidney Cancer Test™ and 222,000
patients from the Rosetta Lung Cancer Test™. The Company’s assays
are offered directly by Rosetta Genomics in the U.S., and through
distributors around the world. In addition to its proprietary
products, the Company markets the Rosetta Genomics PGxOne™ and EGFR
and KRAS tests for Admera Health. With the recent acquisition of
PersonalizeDx, the company now offers a broader menu of molecular
and other assays for lung, bladder, prostate and breast cancer
patients. For more information, please visit
www.rosettagenomics.com. Parties interested in ordering any of
these tests can contact Rosetta Genomics at (215) 382-9000 ext.
309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of
microRNA-based molecular diagnostics. Founded in 2000, Rosetta’s
integrative research platform combining bioinformatics and
state-of-the-art laboratory processes has led to the discovery of
hundreds of biologically validated novel human microRNAs. Building
on its strong patent position and proprietary platform
technologies, Rosetta is working on the application of these
technologies in the development and commercialization of a full
range of microRNA-based diagnostic tools. PersonalizeDx’s core
FISH, IHC and PCR-based testing capabilities and partnerships in
oncology and urology provide additional content and platforms that
complement the Rosetta offerings. Rosetta’s and PersonalizeDx’s
cancer testing services are commercially available through the
Philadelphia, PA- and Lake Forest, CA-based CAP-accredited,
CLIA-certified labs, respectively.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including without
limitation, statements relating to the commercial and
market opportunities for Rosetta's FGFR3 mutation analysis tests,
Rosetta's FGFR3 mutation analysis tests detecting tumors that
conventional detection methods miss, Rosetta's FGFR3 mutation
analysis tests improving patients' outcomes, Rosetta's development
and launch of a microRNA-based assay for bladder cancer risk
and the possibilities for Rosetta's expanding its product
offerings and/or clinical pipeline, constitute forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by these forward-looking
statements as a result of various important factors, including
those risks more fully discussed in the "Risk Factors" section of
Rosetta’s Annual Report on Form 20-F for the year ended December
31, 2014 as filed with the SEC. In addition, any
forward-looking statements represent Rosetta’s views only as of the
date of this release and should not be relied upon as representing
its views as of any subsequent date. Rosetta does not assume any
obligation to update any forward-looking statements unless required
by law.
Company:Rosetta GenomicsKen Berlin, 609-419-9003President
& CEOinvestors@rosettagenomics.comorInvestor:LHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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