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Rosetta to Debut Array-Based Cancer-of-Unknown-Primary Test in H2

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By Justin Petrone

Rosetta Genomics will introduce its first microarray-based diagnostic — a test to identify cancers of unknown primary origin — through its Clinical Laboratory Improvement Acts-compliant facility in Philadelphia during the second half of the year, according to the firm's highest official.

President and CEO Kenneth Berlin said recently that the next-generation version of Rosetta's miRview Mets test will run on an array platform, and that the firm's CLIA lab was recently upgraded to include a microarray room to process the test.

Originally launched on a qRT-PCR platform, miRview Mets enables users to determine the source of cancers of unknown primary origin by profiling microRNA expression. Berlin said that the current test includes 25 tumor types that can be identified, but that the next-generation test will have close to 50.

Berlin made his comments March 16 at the Roth OC Growth Stock conference held in Dana Point, Calif. His presentation was webcast.

According to Berlin, the shift from qRT-PCR to microarray will allow Rosetta to "run more microRNA biomarkers," and is beneficial in terms of "certain royalty obligations that we currently have on the PCR platform."

Rosetta has "already identified the biomarker candidates" for the new miRview Mets, and is "about to exit discovery and go into development," Berlin added. The test will be commercialized in the US by Prometheus Laboratories.

Under the agreement with Prometheus, signed last year, the testing lab has the exclusive rights to commercialize miRview Mets and two other Rosetta tests in the US: miRview squamous, which can differentiate squamous from non-squamous non-small cell lung cancer, and miRview meso, which can differentiate mesothelioma, a cancer connected to asbestos exposure, from other carcinomas in the lung and pleura.

Rehovot, Israel-based Rosetta has similar agreements with other companies that will commercialize miRview Mets. Warnex Medical Labs distributes Rosetta's tests in Canada; Teva Israel distributes the firm's tests in Israel and Turkey; Super Religare Labs covers India, United Arab Emirates, Qatar, and Saudi Arabia; AXA Diagnostics distributes in Italy; and Genetic Technology distributes Rosetta's tests in Australia, New Zealand, and Singapore.

According to Berlin, the market potential for miRview Mets is "greater than 300,000 patients" worldwide. During his talk Berlin discussed two more tests in the company’s pipeline: the miRview Bladder test, which is designed to predict the risk of superficial bladder cancer becoming invasive, and miRview FNA, a fine needle aspirate test to classify non-small cell lung cancer as either squamous or non-squamous. Both tests should launch by the end of 2011, Berlin said.

It is unclear on what platform the other new tests will run. Rosetta did not provide comment in time for this publication.

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