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Rosetta Genomics and Warnex Medical Laboratories Announce Exclusive Distribution Agreement for Rosetta's microRNA-based Assays in Canada
  • Warnex will distribute Rosetta Genomics’ three recently launched miRview™ tests in Canada
  • Warnex is a life sciences company providing laboratory services to the pharmaceutical and healthcare industries
  • The miRview™ tests leverage proprietary microRNA technology developed by Rosetta Genomics, and measure the expression level of specific microRNA biomarkers in tumor samples.

REHOVOT, Israel & PHILADELPHIA & LAVAL, Quebec--(BUSINESS WIRE)--Aug. 10, 2009-- Rosetta Genomics, Ltd. (NASDQ:ROSG), the leading developer of microRNA-based molecular diagnostics, and Warnex Medical Laboratories, a division of Warnex Inc. (TSX:WNX), announced today they have signed an exclusive distribution agreement in Canada for three currently-available diagnostic tests. Under the terms of the agreement, Warnex will market Rosetta Genomics’ miRview™ tests. Samples will be sent from Canada to Rosetta Genomics’ Philadelphia-based CLIA-certified laboratory for analysis. The terms of the deal were not disclosed.

“We are excited to have a well established molecular diagnostic laboratory such as Warnex as our distribution partner in Canada," noted Ronen Tamir, Chief Commercialization Officer at Rosetta Genomics. “Canada is an important market, and this agreement is a significant step as we expand the market for our products in North America. This agreement joins our existing contracts with Prometheus Laboratories in the U.S., and with Teva Pharmaceuticals in Israel and Turkey. We continue in our efforts to expand our global distribution network to other parts of the world, and expect to have additional agreements in place in the near future.”

“We are pleased to add these new tests to our growing portfolio of pharmacogenetic tests,” said Mark Busgang, President & CEO of Warnex. “These tests offered by Rosetta Genomics will allow oncologists to accurately trace the origin of the tumor in the body and to better characterize the tissue type, which can lead to a more efficient chemotherapy treatment.”

The following tests will be distributed by Warnex:

  • miRview™ mets – This test can accurately identify the primary tumor site in patients presenting with metastatic cancer, as well in patients whose tumor has not been identified, and consequently been labeled Cancer of Unknown Primary (CUP). As metastases need to be treated according to their primary origin, accurate identification of the metastases’ primary origin can be critical for determining appropriate treatment. Current diagnostic methods to identify the origin of a metastasis include a wide range of costly, time consuming, and at times inefficient tests. miRview™ mets offers physicians a fast, accurate, and easy to interpret diagnosis of the predicted primary origin.
  • miRview™ squamous – Using a single microRNA, miRview™ squamous differentiates squamous from non-squamous, non-small cell lung cancer (NSCLC) patients. When administered targeted therapy, whether currently available or under development, patients with squamous cell carcinoma of the lung have demonstrated varying response patterns ranging from a high incidence of severe or fatal internal bleeding in the lungs to overall poor response to treatment. Current methods for differentiating squamous from non-squamous non-small cell lung cancer are not standardized, are difficult to reproduce, and have low accuracy. miRview squamous produces a single score which indicates whether a sample is squamous or non squamous NSCLC.
  • miRview™ meso - This test leverages microRNA’s high specificity as biomarkers to differentiate mesothelioma, a cancer connected to asbestos exposure, from other carcinomas in the lung. As mesothelioma patients require specific treatment regimens, accurately diagnosing mesothelioma is critical. Currently, there is no single diagnostic test that is entirely conclusive for this differentiation. In addition, pathological diagnosis may suffer from significant inter-observer variability, and in the absence of a single specific and reliable marker, mesothelioma can be difficult to identify from other cancers. miRview™ meso is a highly accurate test which may also assist physicians to rule out mesothelioma in patients diagnosed with adenocarcinoma in the lung who have been exposed to mesothelioma-related substances, primarily asbestos particles and heavy metals

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 Warnex

Warnex (www.warnex.ca) is a life sciences company devoted to protecting public health by providing laboratory services to the pharmaceutical and healthcare sectors. Warnex Analytical Services provides pharmaceutical and biotechnology companies with a variety of quality control services, including chemistry, chromatography, microbiology, method development and validation, and stability studies. Warnex Bioanalytical Services specializes in bioequivalence and bioavailability studies for clinical trials. Warnex Medical Laboratories provides specialized testing for the healthcare industry as well as pharmaceutical and central laboratory services. Warnex PRO-DNA Services offers DNA identification tests for paternity, maternity and other family relationships, as well as for immigration and forensic testing purposes. Warnex has three facilities located in Laval and Blainville, Quebec, and Thunder Bay, Ontario.

About Rosetta Genomics

Rosetta Genomics (Nasdaq:ROSG) 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 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 tools. The company’s first three microRNA-based tests, miRview™ squamous, miRview™ mets, and miRview™ meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of Wall Street Journal’s Technology Innovation Awards in the medical/biotech category.

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, 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, 2008 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.

Source: Rosetta Genomics, Ltd.

Rosetta Genomics Company Contact:
Ron Kamienchick
646-509-1893
investors@rosettagenomics.com
or
Investor Contacts:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com
or
Bruce Voss
310-691-7100
bvoss@lhai.com
or
Warnex Company Contacts:
Mark J. Busgang
President & CEO
450-663-6724 x 310
mbusgang@warnex.ca
or
Catherine Sartoros
Communications Specialist
450-663-6724 x 277
csartoros@warnex.ca