Accurate Identification of Tumor Origin Using MicroRNAs is Published by Rosetta Genomics Ltd.'s Scientists and Collaborators in Nature Biotechnology

Published: Mar 24, 2008

REHOVOT, Israel and JERSEY CITY, New Jersey, March 24 /PRNewswire-FirstCall/ -- Rosetta Genomics, Ltd. , announced today that the results of a research study, conducted by its scientists and collaborators and describing the use of microRNAs in accurately identifying tumor origin, have been published in Nature Biotechnology. . The study findings demonstrate microRNAs' significant potential to act as effective biomarkers that may be applied in a diagnostic test designed to identify the primary tumor site in patients with cancer of unknown primary (CUP). Rosetta Genomics is currently developing a technology that will be the basis of a CUP diagnostic tests that will be submitted by a CLIA certified lab in the US in 2008..

"Accurately identifying the origin of a metastasis in CUP patients can be critical for determining appropriate treatment, and currently presents a true unmet diagnostic need for patients and physicians," said Amir Avniel, President and CEO of Rosetta Genomics. "This research demonstrates the tremendous potential of microRNAs as effective biomarkers, and is a significant step towards the development of the first microRNA-based diagnostic tests."

Each year approximately 70,000 patients in the United States are diagnosed with CUP. A patient typically is diagnosed with CUP only after undergoing a wide range of tests, including various imaging tests such as x-ray, CT, MRI, and PET, which have failed to identify the origin of the cancer. Accurately identifying the origin of a metastasis can be critical in guiding treatment decisions.

The study results published in Nature Biotechnology describe the development and test validation of microRNA expression profiles for identification of tumor origin. Rosetta Genomics' scientists measured microRNA expression in RNA extracted from hundreds of formalin-fixed, paraffin-embedded (FFPE) samples from more than 20 different known primary tumor tissues and metastases. These results were used to build a classifier which assigns a primary site to a cancer sample based on the microRNA expression in the sample. The paper demonstrates, based on a blinded test set, that the overall sensitivity of this classifier is approximately 85%, with two-thirds of the samples being classified with high-confidence, reaching accuracy exceeding 90% and specificity of 99%.

"The recognition of our research work by a leading, peer-reviewed journal like Nature Biotechnology is truly exciting," noted Dr. Dalia Cohen, Chief Scientific Officer of Rosetta Genomics. "As a leader in the microRNA field, Rosetta Genomics continues to advance and develop microRNA-based technologies that can potentially be applied in a wide range of diagnostics and therapeutics."

The paper, "MicroRNAs accurately identify cancer tissue origin" will be available on Nature Biotechnology's website on Sunday, March 23rd, and will also appear in the April 2008 Volume 26 No 4 edition of the publication.

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 Rosetta Genomics

Rosetta Genomics 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 to develop 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 CLIA-certified 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, and the potential of microRNAs in the diagnosis and treatment of disease 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 and develop 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.

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