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Rosetta Genomics Looking Beyond Cancer to Cardio, Neuro, Women's Health for Blood-Based MDx Program


Testing patient blood samples for diagnostic or prognostic microRNA markers is the "next big thing" for Rosetta Genomics.

CEO Ken Berlin said last week that the company is developing a number of tests that can be performed on bodily fluids from patients. Should Rosetta successfully commercialize these tests, the Rehovot, Israel-based molecular diagnostics firm believes it could address other lucrative markets.

The company already offers a menu of oncology tests that are performed on biopsy samples.

"We have done some work in this area, we have proof of concept, and we are continuing to advance some projects in this space," said Berlin of the company's pipeline of blood-based tests. Berlin, whose remarks were webcast from the Jefferies Healthcare Conference in New York, added that the ability to make a diagnosis from such samples would allow Rosetta to "move beyond cancer into some larger potential indications."

Expanding on this, he said that Rosetta has shown proof of principle in using miRNA signatures to stratify heart failure patients, an internal project he has discussed previously (BAN 4/2/2013 ). Other areas of interest include neurodegenerative diseases and women's health, Berlin said.

A spokesperson told BioArray News this week that the planned blood-based tests from Rosetta Genomics "will preferably be microarray but they will look at all options while in development."

Four of Rosetta's five cancer tests — for cancer of unknown primary origin, lung cancer, mesothelioma, and kidney cancer — are offered as a service on Agilent Technologies-manufactured arrays in Rosetta's CLIA lab in Philadelphia. The fifth test, for non-small cell lung cancer, is offered on a quantitative real-time PCR platform.

All of the firm's current assays are conducted on formalin-fixed, paraffin-embedded tissue samples.

The spokesperson said that the indications Berlin discussed are "areas where Rosetta has done some work in the past," and said that "any future indications or prioritization will be announced as the R&D progresses." She did not elaborate.

To support the development of its blood-based tests, Berlin said that the company "recently reinvigorated its R&D efforts." The company said in March that it had actually reduced its R&D spend in 2012 to $1.2 million from $3.4 million in 2011, following a restructuring.

Berlin noted that the company had cash and equivalents on hand of $31 million entering 2013, and that Rosetta believes it has "sufficient cash to execute our plans."

Rosetta also intends to use that cash to invest in its commercial team. The firm announced separately last week that it intends to expand the number of product managers for its flagship CUP test to 12 from five. Berlin said at Jefferies that the company should have all of those new managers hired by the end of July.

"We have seen growth in the business such that we should be doubling down on our commercial investment," said Berlin.

In March, Rosetta reported full year revenues of about $200,000, roughly double its '11 revenues.

To augment test adoption, Rosetta has also inked credentialing agreements with a number of preferred provider organizations in the past few months.

Last week, it announced such a deal with Three Rivers Provider Network, which will offer the firm's Cancer Origin Test to the Chula Vista, Calif.-based PPO's 10 million members. In May, Rosetta said that it had signed a similar agreement with Brentwood, Tenn.-based managed care firm Prime Health Services to cover the same test for its 6.5 million members.