Warnex Will Distribute Rosetta's Assays in Canada

Under the terms of the agreement, Warnex will market Rosetta Genomics' miRview diagnostic tests. Samples will be sent from Canada to Rosetta Genomics' Philadelphia-based (PA, USA) Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for analysis. Terms of the deal were not disclosed.

The tests leverage microRNA technology developed by Rosetta Genomics, and measure the expression level of specific microRNA biomarkers in tumor samples. The assays include miRview mets, which accurately identifies the primary tumor site in patients presenting with metastatic cancer--called Cancer of Unknown Primary (CUP)--as well in patients whose tumor has not been identified. Accurate identification of the metastases' primary origin is critical for determining appropriate treatment. miRview mets offers physicians a fast, accurate, and easy-to-interpret diagnosis of the predicted primary origin. Current diagnostic methods to identify the origin of a metastasis include a wide range of costly, time-consuming, and sometimes inefficient tests.

The second assay is miRview squamous, which uses a single microRNA to differentiate squamous from nonsquamous nonsmall cell lung cancer (NSCLC) patients. 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. Traditional methods for recognizing differences between the different lung cancers are not standardized, difficult to reproduce, and have poor accuracy.

miRview meso, the third assay is a highly accurate test developed to help physicians rule out mesothelioma in patients diagnosed with adenocarcinoma in the lung, who have been exposed to substances like asbestos particles and heavy metals. Because 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.

Ronen Tamir, CCO at Rosetta Genomics noted, "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 United States], 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."

Rosetta Genomics is a developer of microRNA-based molecular diagnostics. The company's integrative research platform combines bioinformatics and laboratory processes that have led to the discovery of hundreds of biologically validated novel human microRNAs. The company is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. Rosetta Genomics was the 2008 winner of Wall Street Journal's Technology Innovation Awards in the medical/biotech category.

Warnex is a life sciences company devoted to protecting public health by providing laboratory services to the healthcare sector. Warnex Analytical Services provides biotechnology and pharmaceutic companies with a variety of quality control services, including chemistry, chromatography, microbiology, method development and validation, and stability studies.

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