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Rosetta Genomics to Intensify Marketing Outreach for Menu of miRview Microarray Tests

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Awareness, or lack thereof, is the "single greatest issue" facing Rosetta Genomics in its efforts to sell its portfolio of microRNA-based molecular diagnostics, according to CEO Kenneth Berlin.

Berlin recently told investors at the 25th Annual Roth Conference in Dana Point, Calif., that the company plans to direct around $40 million that it raised last year toward commercializing its tests.

"We have never had enough cash to do the commercial execution piece the right way," said Berlin, whose remarks were webcast. He said the firm, which maintains its operations in Philadelphia and Rehovot, Israel, has doubled its sales force in the past two years to eight staffers, and is working with partners to reach prospective clients.

"This is a game of numbers," said Berlin. "You have to get out there, talk to the doctors, and talk to them again."

Rosetta's flagship test is miRview mets2, a microarray containing 64 microRNA markers that is used to distinguish 42 different tumor types for patients suffering from cancer whose primary origin is uncertain. Rehovot, Israel-based Rosetta launched the test through its CLIA-compliant facility in Philadelphia three years ago (BAN 3/23/2010).

Last fall, the company inked a deal with Precision Therapeutics to co-market the test, part of what Berlin called the company's "two-pronged" marketing approach.

During his talk, Berlin also discussed Rosetta's growing menu of other array-based tests. These include miRview lung and miRview kidney, both of which are used for subtyping patients and, unlike miRview mets2, are not yet covered by Medicare.

Of the latter assay, Berlin said that kidney cancer is "one of those cancers coming into the 21st century of personalized medicine," with multiple therapeutics in development, and that subtyping patients is "important" for guiding treatment. Moreover, in some cases, patients show evidence of "multiple subtypes," creating a need for such a molecular test, Berlin said.

Rosetta is highlighting miRview kidney at an upcoming scientific conference and in a pending peer-reviewed publication. First, the company will present a poster next week at the American Association for Cancer Research meeting in Washington, DC, describing the development and validation of the miRview kidney assay, which it said differentiates between the four main types of primary kidney tumors.

The assay was developed on a microarray platform using 181 training samples and validated blindly on an independent set of 201 samples. It was able to return results for 92 percent of the validation samples, with 95 percent accuracy, the company said.

In addition, a manuscript describing the same study has been accepted for publication by the journal Molecular Oncology. An unedited draft of the paper was also published online.

Berlin said in a statement that distinguishing between the four main types of primary kidney tumors is "critical in determining the optimal treatment regimen," and claimed that Rosetta's assay "accurately classifies clear cell renal cell carcinoma, papillary RCC, chromophobe RCC, and oncocytoma." Given such information, patients may be able to avoid "aggressive surgical intervention," Berlin said, adding that "newer therapeutic agents may show evidence of specificity of response by cell type."

At the Roth conference, Berlin discussed the firm's efforts to create miRNA tests that can be run on blood samples and other body fluids. "To date we have been looking at miRNAs in tissue, so by definition we have been in cancer, but we think we have opportunities outside of cancer," he said.

He noted that the firm recently published a study that showed its assay was able to predict heart failure in patients with 90 percent sensitivity and specificity. He described Rosetta's heart failure test as "early in development," but said it has some "nice potential."

With that promise in mind, Berlin said that Rosetta has "revitalized" its R&D efforts to look at blood-based diagnostics, though it will continue to develop tumor-based and tissue-based tests as well, given its testing infrastructure.

Above all, the firm will continue to seek to raise its profile among doctors, and is trying to encourage "peer-to-peer interactions" between its clients and its target customer group — US oncologists and pathologists.

"We think the single biggest issue holding us back today is awareness," said Berlin. "If you can't get access to the doctors, then you can't make them aware."

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