SOURCE: Rosetta Genomics, Ltd.

Rosetta Genomics, Ltd.

May 25, 2012 10:28 ET

Study Validating miRview mets2 Published in The Oncologist

Demonstrates Ability to Accurately Identify Tumor Tissue Origin in Patients With Cancer of Unknown and Uncertain Primary

PHILADELPHIA, PA and REHOVOT, ISRAEL--(Marketwire - May 25, 2012) - Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that data from studies of miRview® mets² in patients with Cancer of Unknown and Uncertain Primary ("CUP") were published online in The Oncologist in an article titled, "A second generation microRNA-based assay for diagnosing tumor tissue origin: An improved microRNA-based mets assay." The study demonstrated the ability of the miRview® mets² assay to identify 42 tumor types with high accuracy and to maintain the same performance in samples from patients clinically diagnosed with CUP, showing an 88% concordance with the clinico-pathological evaluation of the patients. The article can be accessed online at www.ncbi.nlm.nih.gov/pubmed/22618571 and is expected to be published in the print edition of The Oncologist.

The article provides an in-depth description of the test, its development and its mechanism of action. In the study, the assay was first validated on 509 samples of known origin in a blinded manner and demonstrated 85% accuracy, with the vast majority of samples resulting in a single reported origin, which was accurate in 90% of the cases. The study then extended the validation to CUP, which is the most difficult diagnostic challenge for a test designed to identify tumor origin. The investigators performed validation of the assay on CUP cases, assessing the performance of the assay using clinico-pathologic evaluation, and demonstrated that the performance of the assay remains the same for these challenging cases. This high level of accuracy in identifying the tumor-of-origin were similar to the 92% concordance demonstrated in a study conducted in Greece and recently presented at the United States and Canadian Academy of Pathology.

According to the study author, Wolf C. Mueller, M.D., Department of Neuropathology, Ruprecht- Karls- University, Heidelberg, Germany, "Although immunohistochemistry markers are widely used and well characterized, they are unable to determine a definitive tissue of origin in over 30% of cases, and are highly subjective and dependent on many variables. It is therefore a substantial need to find complementary diagnostic tools for determining tissue of origin."

The study concluded that, "The ability of the [miRview® mets²] assay to identify 42 tumor types with high accuracy and to maintain the same performance in samples from patients clinically diagnosed with CUP, promises improved utility in the diagnosis of cancers of unknown/uncertain primary."

"There is a growing need for an assay that can accurately identify the tumor-of-origin in CUP patients as there are an estimated 180,000 to 220,000 CUP cases per year in the U.S. In addition to presenting a diagnostic challenge, these cases also present a clinical challenge since knowing the tumor tissue-of-origin is crucial for selecting optimal treatment," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "The identification of tumor origin is critical for patient management as many oncology treatments are based on knowledge of the specific tumor type, especially with the growing number of cytotoxic and targeted therapies shown to be effective against specific cancers. In addition, clinical trial enrollment criteria as well as reimbursement strategies are based on knowing the cancer's primary origin."

"We are pleased to have these positive data confirm the ability of miRview® mets² to identify the tumor-of-origin in real-world CUP patients with such a high level of accuracy. These data, in combination with our recent receipt of Medicare coverage for miRview mets², underscore the value our assays are delivering to physicians, payors and patients and form a strong foundation for the commercial adoption of miRview mets² in the marketplace," added Mr. Berlin.

"This is the fifth peer-reviewed publication relating to our miRview® mets2 assay which speaks to the strong underlying clinical and analytical data supporting these products' It is also the 34th peer-reviewed publication covering our work, including studies describing our commercial assays and their performance, as well as studies describing new microRNA diagnostic and therapeutic markers, discovery of novel microRNAs and reviews, which speaks to the robustness of our microRNA platform," concluded Mr. Berlin.

About miRview® Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets and miRview® mets² accurately identify the primary tumor type in primary and metastatic cancer including 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 or fatal internal bleeding and poor response to treatment for certain therapies. 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® mets and miRview® mets² test, 60,000 from miRview® squamous, 60,000 from miRview® meso, 54,000 from miRview® kidney and more than 1 million patients worldwide from miRview® lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the globe. 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 Genomics develops and commercializes a full range 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 and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visit www.rosettagenomics.com.

Forward-Looking Statements
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the commercial adoption of miRview mets² in the marketplace, 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 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; the ability to obtain a formal agreement for Medicare coverage and to maintain an equitable reimbursement valuation; 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, 2011 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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