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Rosetta Genomics Could Debut Colon Cancer Screen in US This Year, Shifts Focus from Dxs

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This story has been updated to include comments by Rosetta management and the company's fourth-quarter financial results.

Rosetta Genomics this week said it could begin selling its blood-based microRNA screening diagnostic for colon cancer in the US before the end of the year, rather than in 2010 as previously expected.

According to Rosetta President and CEO Amir Avniel, the accelerated timeline stems from the company's decision to mostly limit its product-development efforts in 2009 to the colon cancer screen, dubbed miRscreen Colon, which could debut late this year or in early 2010.

It also coincides with a broader change in business strategy in which Rosetta will focus on developing tests for screening, rather than diagnosing, disease.

"We recognize that this new emphasis on miRscreen Colon is a change in our business focus, or more specifically, in the timing and prioritization of activities," Avniel said during a conference call held this week to discuss the company's fourth-quarter financial results. "Nevertheless, we believe this focus can potentially provide significant value."

With roughly 90 million Americans estimated to be candidates for miRscreen Colon, the test "represents, far and away, the largest commercial opportunity to date for us."

He also said the company is "highly encouraged by miRscreen Colon data reported earlier this year at the American Society of Clinical Oncology's 2009 Gastrointestinal Cancers Symposium, which showed that the expression patterns of two miRNAs in serum can be used to identify the presence of the disease with 91 percent sensitivity and 72 percent specificity (see RNAi News, 1/22/2009).

At the same time, "we have determined that our main focus will be on screening tests, with colon cancer screening being the first of these," he added. "Screening tests target millions of healthy individuals and … therefore, potentially hold enormous … financial impact on our company," especially if the tests become the standard of care.

Rosetta said that it expects to complete discovery-stage work on the colon cancer test, dubbed miRscreen Colon, and select the test's final miRNA content by the end of the second quarter.

By the end of the third quarter, it expects to conclude assay-development work. "In this phase, as we have done with our first three products, we will translate the discovery results into an assay," Rosetta said. The company last year commercialized its first three miRNA-based cancer diagnostics (see RNAi News, 12/31/2008), all of which analyze the expression patterns of the small RNAs in tissue samples.

"This means we will finalize the list of biomarkers, the design of the plate, the various controls and [quality-control] parameters, as well as the optimal interpretation of the assay results" for miRscreen Colon, the company added.

Developing miRscreen Colon through to product launch is expected to cost Rosetta about $5.5 million, Avniel said during the call. However, since this is roughly what the company expected to spend on its other research and development programs during 2009, "in essence, we are accelerating the development of miRscreen Colon by a year and slightly delaying our other work with largely no change to our projected cash burn," he noted.

Rosetta said that if it is able to successfully develop miRscreen Colon, the test will be marketed in the US through the company's Clinical Laboratory Improvement Amendments-certified laboratory.

"These are ambitious goals … [and] let me caution that there are risks along the way in developing and ultimately commercializing this product," Avniel said in the statement. "From a technical perspective, this is a complicated test and will be the first product of its kind to be commercialized, and we can provide no assurance that we will be able to successfully develop this product in this timeframe, or at all."

miRNA Dx, Rx Projects

Even though Rosetta has made miRscreen Colon its top priority for 2009 and views screening tests as its primary focus going forward, the company said it has not abandoned its miRNA diagnostic projects.

It previously announced that it was developing a number of other tests that analyze miRNA signatures obtained from tissue samples, including one to predict how ovarian cancer patients will respond to treatment, one to predict the likelihood of gastric cancer recurrence, and one to differentiate small cell lung cancer from non-small cell lung cancer. Beginning next year, Rosetta plans to re-start work on these programs, either alone or with a partner, as well as possibly other non-invasive screening tests, the company said.

The future of Rosetta's efforts to develop a miRNA-targeting drug for liver cancer, being done in collaboration with Regulus Therapeutics, is unclear, however.

Earlier this year, the company announced data showing that suppression of microRNA-191, which is over-expressed in human liver cancer, led to a two-fold reduction in tumor mass in an animal model of the disease (see RNAi News, 2/19/2009).

No mention of the liver cancer program was made during the conference call. Rosetta officials were unavailable for comment by press time.

Fourth-Quarter Financials

In the fourth quarter, Rosetta posted revenues of $806,000, compared with zero revenues in the year-ago period. The revenues for the most recent period were derived entirely from services provided by the company's CLIA lab, which it acquired in mid-2008 (see RNAi News, 7/24/2008).

The company's net loss in the quarter dropped to $9.5 million, or $0.79 per share, from $14.7 million, or $1.32 per share, the year before. Rosetta's operating loss in the quarter rose to $4.5 million from $3.5 million in the fourth quarter of 2007.

R&D spending in the quarter was essentially flat with the year before at $2.1 million, while general and administrative expenses edged up to $3.7 million from $2.9 million.

As of Dec. 31, Rosetta had $15.7 million in cash, cash equivalents, short- and long-term bank deposits, and marketable securities.

Looking ahead, the company expects to burn roughly $10 million in 2009, exclusive of the potential beneficial impact from any new distribution partnerships.

Earlier this year, Rosetta said that it had hired Israeli drugmaker Teva Pharmaceuticals to exclusively distribute its miRNA-based diagnostics in Israel and Turkey (see RNAi News, 1/8/2009). Avniel said this week that the company continues to pursue distribution partnerships for the US and other markets.

Rosetta said it expects that its cash resources will be sufficient to fund operations until mid-2010. Avniel noted during the call that the company "may pursue sources of additional funds during 2009, which may include funds generated through strategic collaborations or equity financing."

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