Molecular Pathology Laboratory Submits Diagnostic Lung Cancer Test For Nys Approval

The laboratory-developed test is designed to differentiate squamous from non-squamous non-small cell lung cancer (NSCLC), classifying squamous cell carcinoma of the lung with sensitivity of 96 percent and specificity of 90 percent Accurate diagnosis is important for guiding treatment. Bevacizumab(1) therapy for non-squamous NSCLC, includes a warning about potential higher rates of severe or fatal hemorrhage in patients with squamous NSCLC histology. Once approved by the New York State Department of Health, the test will be available nationwide through Columbia University Medical Center’s Molecular Pathology Laboratory, which developed and validated the test.

Rehovot, Israel; Jersey City, New Jersey, New York (April 3, 2008) – Rosetta Genomics, Ltd. (NASDQ: ROSG) and Columbia University Medical Center (CUMC) announced today that the first molecular test based on Rosetta Genomics’ proprietary microRNA technology, developed by CUMC, has been submitted for approval by the New York State Department of Health. The test is designed to differentiate squamous from non-squamous NSCLC and is the first to use this technology to successfully classify two distinct types of the most common form of lung cancer.

Once approved by New York State Department of Health, the test will be made available nationwide through Columbia University Medical Center’s High Complexity Molecular Pathology Laboratory, a laboratory licensed to use nucleic acids for better diagnosis of various cancers, which is part of the Department of Pathology and Cell Biology at CUMC.

“With advancements toward more targeted therapies for cancer, there is a growing need for better diagnostics,” said Amir Avniel, President and CEO of Rosetta Genomics.

The test, performed on a sample of the patient’s tumor and validated by Columbia University Medical Center, classifies squamous cell carcinoma of the lung with specificity of 90 percent and sensitivity of 96 percent. This is the first test utilizing microRNAs’ unique sensitivity and specificity as biomarkers that may offer a standardized and objective method for cancer classification.

The genetic classification can be especially important for selecting proper treatment as therapies have been shown to act differently depending on cancer type, such as the case between squamous (scalelike) and non-squamous non-small cell lung cancer (NSCLC). Approximately 185,000 people are diagnosed with either squamous or non-squamous NSCLC each year in the United States.

“The importance of accurately differentiating squamous cell from non-squamous NSCLC has recently been an issue of great interest and is gaining importance as new targeted therapies for NSCLC enter the market or proceed to late stages of development,” said Dr. Dalia Cohen, chief scientific officer of Rosetta Genomics. “This is a great advancement in terms of physicians’ ability to better treat patients with targeted therapies, which are currently highly effective in some patients while being less effective and sometimes harmful for others.”

“We are excited to have performed the validation of the first diagnostic test based on microRNAs, and believe this endeavor is an important next step in bringing better diagnostics to patients and physicians,” noted Dr. Mahesh Mansukhani, director of the Molecular Pathology Laboratory at Columbia University Medical Center, who has led the validation process and submission of the test to the New York State Department of Health for approval. “Using a single microRNA biomarker, the test demonstrates high sensitivity and specificity, for squamous differentiation. Once approved, we will be pleased to offer this test through our pathology laboratory nationwide to doctors and patients as an objective aid in the classification of NSCLC. “

Data presented in peer reviewed publications has shown that two blinded expert observers, when asked to give an independent histological classification of NSCLC agreed only 74.7 percent of the time. Furthermore, sensitivity for squamous cell carcinoma was only 70.9 percent (2). A second study (3) looking at classification of squamous cell carcinoma showed that 40 percent of samples diagnosed as squamous cell lung cancer at regional labs were later reclassified as other lung cancers at central labs.

The ability of physicians to accurately differentiate squamous (scalelike) from non-squamous NSCLC is an important treatment guide. Bevacizumab (1), an angiogenesis inhibitor and an important new modality of therapy for non-squamous NSCLC, includes a black-box warning about substantially higher rates of severe or fatal hemorrhage among patients with squamous NSCLC histology compared with non-squamous NSCLC.

Currently, an estimated 60,000 patients per year are potential candidates for targeted therapy with Avastin™, a market available angiogenesis inhibitor, in the United States.

Rosetta Genomics expects two additional tests based on its microRNA technology to be validated and submitted for regulatory approval during the second half of 2008 by laboratories in the United States. One test is designed to differentiate mesothelioma, an asbestos-associated cancer that develops in the pleura, from adenocarcinomas that either arise in the lung or spread to the lung and pleura from other sites. Another test is designed to identify the origin of a metastasis in patients presenting with cancer of unknown primary (CUP) origin.

About microRNAs MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases. In addition, microRNAs have been shown to have different expression in various pathological conditions. As a result, these differences may provide for a novel diagnostic strategy for many diseases.

About the CUMC Molecular Pathology Laboratory: The Columbia University Medical Center Molecular Pathology Laboratory is a high complexity molecular pathology laboratory that provides nucleic acid-based testing in the fields of molecular oncology and molecular genetics, with New York state permits in the categories of genetic testing, molecular oncology, molecular and cellular tumor markers; and virology general, virology limited to molecular techniques - currently performing over 30,000 tests per year in these categories. The laboratory is a component of the Department of Pathology and Cell Biology of Columbia University Medical Center, a national leader in diagnostics and research on disease.

About Columbia University Medical Center Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions.

About Rosetta Genomics Rosetta Genomics (Nasdaq: ROSG) is a leader in the field of microRNA. 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 IP 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 and therapeutic tools, focusing primarily on cancer and various women’s health indications. The company expects that the first microRNA diagnostic tests applying its technology will be launched by licensed clinical laboratories in the United States in 2008.

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 the expected timing of submission for approval and launch of diagnostic tests using our microRNA technology 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 is unproven and may never lead to marketable products or services; Rosetta’s ability to fund and the results of further pre-clinical and clinical trials; Rosetta’s ability to obtain, maintain and protect the intellectual property utilized by Rosetta’s products; Rosetta’s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta’s 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, all of which are in early stages of development; 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, 2006 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.

(1)Avastin™, a registered trademark of Genentech, Inc.

(2) Field RW, Smith BJ, Platz CE, Robinson RA, Neuberger JS, Brus CP, et al. Lung cancer histologic type in the Surveillance, epidemiology, and end results registry versus independent review. J Natl Cancer Inst 2004;96:1105—7

(3) Andreas Stang ,Hermann Pohlabeln , Klaus M.Muller ,Ingeborg Jahn , Klaus Giersiepen, Karl-Heinz Jockel Diagnostic agreement in the histopathological evaluation of lung cancer tissue in a population-based case-control study. Lung Cancer (2006) 52 ,29 —36


Categories, NSCLC, Rosetta Genomics, United States