SOURCE: Rosetta Genomics, Ltd.

Rosetta Genomics, Ltd.

September 27, 2010 14:09 ET

New Data Published in "The Journal of Molecular Diagnostics" Demonstrate Rosetta Genomics' miRview meso is a Highly Sensitive Test for Differentiating Mesothelioma From Carcinomas in the Lung or Pleura

Accurate Identification Is Critical to Treatment Decisions and May Have Legal Implications for Asbestos-Related Mesothelioma

REHOVOT, ISRAEL and PHILADELPHIA, PA--(Marketwire - September 27, 2010) -  Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that a peer reviewed article entitled "A diagnostic assay based on microRNA expression accurately identifies malignant pleural mesothelioma" appears in the online version of The Journal of Molecular Diagnostics. The study demonstrates the ability of the Company's miRview™ meso test to accurately differentiate malignant pleural mesothelioma (MPM) from primary and metastatic carcinomas in the lung and pleura. The study is available online at http://jmd.amjpathol.org/cgi/content/abstract/jmoldx.2010.090169v1

The study included formalin-fixed, paraffin-embedded (FFPE) samples that were explored using microRNA microarrays to identify potential biomarkers. Based on these data, a qRT-PCR platform was utilized to verify findings and develop a diagnostic assay. The clinical validation of this diagnostic assay was performed on 68 samples from the lung and pleura and achieved a sensitivity of 100% and a specificity of 94%.

"Differentiating MPM from primary and metastatic carcinoma in the lung and pleura can be challenging for pathologists, even with the use of immunohistochemistry," noted Tina Edmonston, M.D., Medical Director and Head of Clinical Laboratory at Rosetta Genomics. "There is no single immunohistochemical marker that distinguishes between MPM and various carcinomas that may be in the differential diagnosis. Moreover, the choice of markers, as well as interpretation of the results in equivocal cases can be subjective."

"Malignant pleural mesothelioma is a very aggressive solid malignant tumor of the pleura that leads to a severe, clinically-symptomatic disease with very poor prognosis. Accurately distinguishing MPM from other carcinomas affecting the lung and pleura is important, as it guides treatment decisions, particularly for the newer immunomodulating and targeted therapeutics on the market and in development," added Dr. Edmonston.

"We are especially pleased that these positive data underscore the accuracy of our miRview meso test and its ability to rule out MPM so that clinicians might access the most appropriate treatment options. The largest risk factor for developing MPM is exposure to asbestos, which has a characteristic 20- to 50-year latency between exposure and the development of the malignancy. The widespread use of asbestos from the 1940s through the 1970s in the U.S. and Europe is now resulting in a growing number of cases of MPM," commented Kenneth A. Berlin, President and CEO of Rosetta Genomics. "Even though asbestos is no longer used today, there are many workers who are exposed to asbestos, such as demolition and construction workers, first responders, auto mechanics, shipyard workers, plumbers and others. Consequently, whenever a mass in the lung is presented in a member of this group, the physician usually needs to rule out MPM. There are an estimated 60,000 such cases in the U.S. and an additional 300,000 such cases outside the U.S. This study shows that our miRview meso test can distinguish MPM from carcinomas in the lung and pleura objectively and with a very high level of accuracy."

About microRNAs
MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. The unique advantage of microRNAs as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle aspirate (FNA) cell blocks. It has been suggested that their small size (19 to 21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit www.rosettagenomics.com.

About miRview™ Products
miRview™ are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview™ mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary (CUP). miRview™ squamous accurately identifies the squamous subtype of non small cell lung cancer, which carries an increased risk of severe of fatal internal bleeding and poor response to treatment for certain therapies. miRview™ meso diagnoses mesothelioma, a cancer connected to asbestos exposure. 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 US alone, over 100,000 patients a year may benefit from the miRview™ mets test, 60,000 from miRview™ squamous, and 60,000 from miRview™ meso, with similar numbers of patients outside the US. The company's tests are now being offered through distributors around the globe. For more information, please visit www.mirviewdx.com.

About Rosetta Genomics
Rosetta Genomics is a leading developer of microRNA-based molecular diagnostics. Founded in 2000, the company'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 Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. The company's first three microRNA-based tests, miRview™ squamous, miRview™ mets and miRview™ meso, are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visit www.rosettagenomics.com.

Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, the potential of microRNAs in the diagnosis and treatment of disease, and Rosetta's expected expansion of its global distribution network 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 risks related to: Rosetta's approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta's ability to obtain, maintain and protect its intellectual property; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's need and ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta's ability to successfully develop its candidate tools, products and services; Rosetta's ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta's technology; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; and Rosetta's short operating history; as well as 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, 2009 as filed with the Securities and Exchange Commission. 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.

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