Study Validating Ability of microRNAs to Predict Progression of Bladder Cancer Published in British Journal of Urology

Study Validating Ability of microRNAs to Predict Progression of Bladder Cancer
            Published in British Journal of Urology International

PR Newswire

PHILADELPHIA and REHOVOT, Israel, Feb. 7, 2013

PHILADELPHIA and REHOVOT, Israel, Feb.7, 2013 /PRNewswire/ -- Rosetta
Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of
microRNA-based molecular diagnostics, today announced that data from a study
demonstrating the ability of microRNA expression to serve as a biomarker to
predict the progression of bladder urothelial carcinoma were published online
in the British Journal of Urology International, in an article entitled,
"Predicting progression of bladder urothelial carcinoma using microRNA
expression." The article can be accessed online at
http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2012.11748.x/abstract
and is expected to be published in the print edition of the British Journal of
Urology International.

In the study, formalin-fixed, paraffin-embedded samples of 108 non-muscle
invasive ("NMI") bladder carcinomas, and 29 muscle invasive tumors, were
collected and highly specific microRNA expression levels were measured by
Rosetta Genomics' microarray technology. Using micro-dissection, specific
tumor microRNAs were chosen to be included in the study in order to avoid
background contamination derived from surrounding tissue. The study found
that the expression level of one microRNA, miR-29c*, was significantly
under-expressed in tumors that progressed and could be used to stratify
bladder cancer patients into risk groups.

The study showed that significantly higher expression of miR-29c* was detected
in NMI bladder tumors that did not progress compared with lesions that did
progress. The lower expression of miR-29c* in patients that later progressed
was similar to the expression levels seen in patients with muscle invasive
disease.

Prediction of recurrence and progression is currently based upon clinical and
pathological factors such as: tumor grade, tumor stage, number of lesions,
tumor size, prior recurrence rate and presence of concomitant carcinoma
in-situ ("CIS"). These factors are not specific enough to predict progression
and approximately 50% of patients diagnosed as high risk in fact do not
progress within 3 years. The follow up on patients is expensive, and requires
invasive procedures that are uncomfortable for the patient and can lead to
complications.

Study author Prof. Ofer Nativ, M.D., Department of Urology, Bnei Zion Medical
Center in Haifa, Israel, noted, "Despite the utilization of clinical and
pathological factors, the ability to assess patient prognosis is not
satisfactory, partially due to the subjectivity of grading and staging that
causes relatively high inter-observer variability. Since follow-up and
treatment regimens depend on prognosis, there is a need for more accurate
stratification to increase the predictive values of risk groups. With a
reliable diagnostic test for progression, suitable treatment could be tailored
to each patient. This study showed that microRNA can be useful biomarkers for
prognosis in patients with urothelial carcinoma and that the expression levels
of several microRNAs, including miR-29c, identified high- and low-risk groups.
These biomarkers show promise for stratification of bladder cancer patients."

"This publication adds to the growing body of clinical data demonstrating the
utility of microRNA expression for predicting progression of disease, and for
stratification of patients with bladder cancer," stated Kenneth A. Berlin,
President and CEO of Rosetta Genomics. "According to the American Cancer
Society, urothelial cancer of the bladder is the fourth most common cancer in
men in the Western world. New treatment options in oncology make it more
important than ever to know the potential risk of disease progression. Our
proprietary microRNA technology, with its predictive value, may have a
significant impact on treatment and follow-up care for individual patients."

About Bladder Cancer
Bladder cancer begins when normal cells in the bladder lining, most commonly,
urothelial cells, change and grow uncontrollably, forming a mass called a
tumor. Most bladder cancers are transitional cell carcinomas (cancer that
begins in cells that normally make up the inner lining of the bladder). Other
types include squamous cell carcinoma (cancer that begins in thin, flat cells)
and adenocarcinoma (cancer that begins in cells that make and release mucus
and other fluids). The cells that form squamous cell carcinoma and
adenocarcinoma develop in the inner lining of the bladder as a result of
chronic irritation and inflammation. Bladder cancer may be described as
noninvasive, non-muscle-invasive, or muscle-invasive. Both noninvasive and
non-muscle-invasive bladder cancers have the possibility of spreading into the
bladder muscle or to other parts of the body. Additionally, all cell types of
bladder cancer can metastasize (spread) beyond the bladder.

According to the National Cancer Institute, it is estimated that 73,510 men
and women (55,600 men and 17,910 women) will be diagnosed with and 14,880 men
and women will die of cancer of the urinary bladder in 2012.

About miRview^® Products
miRview^® are a series of microRNA-based diagnostic products offered by
Rosetta Genomics. miRview^® mets² accurately identifies the primary tumor type
in primary and metastatic cancer including CUP. miRview^®meso diagnoses
mesothelioma, a cancer connected to asbestos exposure. miRview^® lung
accurately identifies the four main subtypes of lung cancer using small
amounts of tumor cells. miRview^® kidney accurately classifies the four most
common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC,
chromophobe RCC and oncocytoma. miRview^® tests are designed to provide
objective diagnostic data; it is the treating physician's responsibility to
diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta
Genomics estimates that 200,000 patients a year may benefit from the miRview^®
mets² test, 60,000 from miRview^®meso, 54,000 from miRview^® kidney and
226,000 patients from miRview^® lung. The Company's assays are offered
directly by Rosetta Genomics in the U.S., and through distributors around the
world. For more information, please visit www.mirviewdx.com. Parties
interested in ordering the test 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.
Rosetta's miRview® product line is commercially available through its
Philadelphia-based CAP-accredited, CLIA-certified lab. Frost & Sullivan
recognized Rosetta Genomics with the 2012 North American Next Generation
Diagnostics Entrepreneurial Company of the Year Award.

Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future expectations,
plans and prospects, including without limitation, statements relating to
Rosetta's strategic plan, the market acceptance of Rosetta'smiRview^® assays,
particularly miRview^® mets^2,Rosetta's capitalization of its microRNA
platform and Rosetta's development of personalized medicine products
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, 2011 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 Contact:      Investor Contacts:
Rosetta Genomics       LHA
Ken Berlin, President & CEO Anne Marie Fields
(215) 382-9000, ext. 326           (212) 838-3777
investors@rosettagenomics.com      afields@lhai.com
                                                 or
                                                 Bruce Voss
                                                 (310) 691-7100
                                                 bvoss@lhai.com

SOURCE Rosetta Genomics Ltd.
 
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