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Rosetta to Delay Certain miRNA Diagnostics as It Markets Certain Others Itself

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This article has been updated to include comment from Rosetta's management on the firm's next-generation diagnostics.

By Doug Macron

Rosetta Genomics this week said that it plans to handle at least a portion of the marketing efforts for its microRNA-based cancer diagnostics in the US, a decision made fewer than six months after it re-acquired the products' rights from one-time partner Prometheus Laboratories.

The move, however, will require Rosetta to shift resources away from certain research and development activities, and the firm has therefore delay the planned launch of certain new products for an undisclosed period of time.

Rosetta made the disclosure while announcing its fourth-quarter financial results, which included lower losses on decreased expenses.

“Our strategy is to focus our resources on commercializing our miRview Mets tests,” miRview Mets and miRview Mets 2, which are designed to determine the source of cancers of unknown primary origin, Rosetta President and CEO Kenneth Berlin said in a statement. As such, the company is “in the process of recruiting four to five independent sales representatives with an oncology focus to launch our microRNA-based diagnostic tests in several key oncology markets on the East Coast.”

Notably, Rosetta made no mention of its two other existing tests: miRview Meso, which is designed to differentiate lung cancer from mesothelioma, and miRview Squamous, which aims to differentiate squamous from non-squamous non-small cell lung cancer. It is unclear whether Rosetta intends to find a partner for their continued commercialization.

Rosetta did say that the change to its marketing strategy means it has put on hold two products still in early-stage development: miRview Kidney, designed to differentiate clear cell, papillary, and chromophobe renal-cell carcinoma from benign kidney tumors; and miRview Meso Prognostic, which sub-classifies mesothelioma patients based on their prognosis.

Rosetta had previously said it would introduce these two tests, along with three other second-generation products, before the end of 2011. The first of those, miRview Mets 2, was launched in December (GSN 12/16/2010). No details were provided on the other two: miRview Bladder, designed to assess the risk of superficial bladder cancer becoming invasive; and 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

The Israeli firm also said that it has made some changes to its pipeline of third-generation miRNA diagnostics, which are being designed to identify patterns of the small, non-coding RNAs obtained from biofluids, but provided few clues as to what that lineup will look like.

Berlin did note, however, that the new tests would focus on “very large market opportunities in cardiovascular indications, neurodegenerative diseases, women's health, and early detection of certain cancers.”

Working in collaboration with various Israeli academic centers, Rosetta aims to have proof-of-concept data for a third-generation test in at least one indication by the end of the year, Berlin noted during a conference call held this week to discuss the financial results.

Q4

For the three-month period ended Dec. 31, Rosetta's net loss fell to $3.5 million, or $0.21 per share, from a year-ago loss of $4.1 million, or $0.29 per share.

Revenues declined to $45,000 from $136,000 year over year.

Meanwhile, R&D costs slipped to $1.2 million from $1.7 million as marketing and business-development spending edged up to $1.6 million from $1.3 million one year ago. General and administrative expenses fell to $665,000 in the fourth quarter from $1.2 million in the same period a year earlier.

At the end of 2010, Rosetta had $3.3 million in cash, cash equivalents, restricted cash, short-term bank deposits, and marketable securities. This does not include the $5.5 million netted in a February private stock offering.


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