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With Second-Gen Test Menu in Place, Rosetta Genomics Sets Sights on Third-Gen Pipeline

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By Bernadette Toner

Less than a week after disclosing details of five second-generation assays that it plans to launch before the end of next year, Rosetta Genomics said that it is working on 10 additional projects that it said will bolster its product pipeline beyond that date.

At the Rodman & Renshaw Healthcare conference in New York this week, Rosetta Genomics CEO Kenneth Berlin said that the company currently has 10 third-generation projects in its discovery pipeline "that are either underway or under evaluation."

Unlike the three tests that the company currently has on the market and the five "Gen 2" tests that it plans to launch by the end of 2011, the "Gen 3" assays will not be focused on oncology. They will also not rely on tissue samples, but will instead be based on various body fluids, Berlin said.

Rosetta's product portfolio currently includes miRview Meso, which is designed to differentiate lung cancer from mesothelioma; miRview Mets, which is meant to determine the source of cancers of unknown primary origin; and miRview Squamous, which aims to differentiate squamous from non-squamous non-small cell lung cancer.

The company's second-generation pipeline, which it outlined during its second-quarter earnings call last week (GSN 9/9/2010), includes five tests: miRview Bladder, designed to assess the risk of superficial bladder cancer becoming invasive; miRview Lung, an enhanced version of miRview Squamous that is meant to distinguish between neuroendocrine and non-small cell lung cancer and to sub-classify non-small cell lung cancer patients into squamous and non-squamous subtypes; miRview Mets2, an expanded version of miRview Mets that includes more than 40 cancer types; miRview Kidney, aimed at identifying clear cell, papillary, and chromophobe renal-cell carcinoma and benign kidney tumors; and miRview Meso Prognostic, designed to sub-classify mesothelioma patients based on their prognosis.

This week, Berlin reiterated Rosetta's goal to launch all five Gen 2 tests before the end of next year, with the caveat that the US Food and Drug Administration's plan to change how it regulates laboratory-developed tests could impact the timeline.

He said that Rosetta expects to launch the miRvew Mets2 test outside the US before the end of the year, while the lung and kidney assays are slated for a Q2 2011 launch and the bladder and mesothelioma prognostic tests are targeted for launch in the second half of 2011.

"In addition, we are expanding our focus and moving beyond oncology, looking at body-fluid-based diagnostic opportunities," he said, referring to the 10 projects that are still in R&D. He did not provide additional details about these Gen 3 assays, but said that they will focus on neurodegenerative and cardiovascular diseases, and women's health.

So far, he said, Rosetta has performed proof-of-concept testing for several of the Gen 3 tests and expects to be able to present initial results in the first half of next year.

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