SOURCE: Rosetta Genomics, Ltd.

Rosetta Genomics, Ltd.

July 02, 2012 09:00 ET

Study Validating Rosetta Genomics' miRview lung Assay Published in Journal of Molecular Diagnostics

Assay Shown to Accurately Differentiate Between the Four Main Types of Lung Cancer

PHILADELPHIA, PA and REHOVOT, ISRAEL--(Marketwire - Jul 2, 2012) -  Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, announced that data from a study validating the Company's miRview® lung assay was published in the online edition of the Journal of Molecular Diagnostics in an article titled, "Classification of the Four Main Types of Lung Cancer Using a MicroRNA-Based Diagnostic Assay."  The abstract for this article can be accessed online at http://www.journals.elsevierhealth.com/periodicals/jmdi/article/S1525-1578%2812%2900125-0/abstract?source=aemf

The miRview® lung assay is based on the expression levels of eight microRNAs, measured using a sensitive quantitative RT-PCR platform. In this study, the assay was validated on an independent set of 451 samples, more than half of which were preoperative cytologic samples (fine-needle aspirations and bronchial brushings and washings). More than 90% of the samples were successfully processed with an overall accuracy of 94%. Similar performance was observed in both pathologic and cytologic samples, demonstrating the assays' ability to differentiate between four major types of lung cancer: squamous cell carcinoma, non-squamous non-small cell lung cancer, carcinoid, and small cell carcinoma.

The study noted that, "For patients with primary lung cancer, accurate determination of the tumor type significantly influences treatment decisions. However, techniques and methods for lung cancer typing lack standardization. In particular, owing to limited tumor sample amounts and the poor quality of some samples, the classification of primary lung cancers using small preoperative biopsy specimens presents a diagnostic challenge using current tools."

The study concluded that, "miRview® lung is a simple and reliable diagnostic assay that offers an accurate and standardized classification tool for primary lung cancer using pathologic and cytologic samples."

"We are very pleased to have these positive data on our miRview® lung assay published in this prestigious peer reviewed journal, particularly as it comes on the heels of our recent approval from the New York State Department of Health to test patient samples in the State. Now, miRview® lung is available for testing patient samples in all 50 states," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "The ongoing publication of positive data such as these further validate our microRNA diagnostic assays and platform, and are a testament to the potential of our powerful microRNA technology platform. Importantly, these peer-reviewed articles form the foundation of our scientific- and clinically-based educational and commercial efforts. This study marks the 35th peer-reviewed publication covering our work in the area of microRNAs, which we believe speaks to the robustness and breadth of our microRNA platform.

"New lung cancer treatments that are tumor specific require accurate sub-classification to optimize treatment strategies. Our miRview® lung assay, with its proven ability to differentiate four major sub-types of lung cancer, can provide a simple and reliable tool for clinicians in developing their treatment protocols. The National Cancer Institute estimates that there will be more than 226,000 new cases of lung cancer in the U.S. in 2012 making it the second most common cancer. In addition, as lung cancer is the primary cause of cancer-related death in both men and women in the U.S., we believe the use of this important cancer diagnostic will benefit physicians, patients and payers in efficiently and effectively managing this serious disease," 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 226,000 from miRview® lung. The Company's tests 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 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, 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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