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Rosetta Debuts First miRNA Test, Adds Lung Cancer to Blood-Based Dx Pipeline

Rosetta Genomics this week said that it has begun marketing its first microRNA-based diagnostic, miRview Squamous, designed to differentiate squamous from non-squamous non-small cell lung cancer, and that it has finished building a new lab facility in Pennsylvania that will perform tissue analysis for the test.
“For the last several months, Rosetta scientists from our Israel facility have been hard at work getting this lab up and running,” Rosetta CEO Amir Avniel said during a conference call held last week to discuss the company’s third-quarter financial results. “It is now operational … capable of supporting the expected initial order flow, and has enough space to allow us organic growth” to meet increased demand.
The product launch follows Avniel’s disclosure during the call that Rosetta has added lung cancer to the list of indications it plans to pursue in developing blood-based tests for early cancer detection.
“We have now begun to leverage our microRNA technology to launch a new diagnostic-development program that will potentially yield microRNA extracted from a simple blood draw, and potentially other body fluids, to detect cancer,” Avniel said.
Late this summer, Rosetta first announced that it would be developing a blood test to detect a miRNA signature indicative of colon cancer (see RNAi News, 8/21/2008). But last week, Avniel said that the company had added lung cancer to this effort, and that it will “consider other indications” as the technology progresses.

“The ability to detect cancer at an early stage is critical to increase survival rates, and we believe our future test will be able to address true unmet medical needs in this field. This program will play a key part in our pipeline-development efforts.”

“The ability to detect cancer at an early stage is critical to increase survival rates, and we believe our future test will be able to address true unmet medical needs in this field,” he added. “This program will play a key part in our pipeline-development efforts, and we believe it will allow us to offer a minimally invasive, microRNA-based diagnostic tool.
Meanwhile, Rosetta has completed work on a new 6,200-square foot laboratory in Philadelphia that will handle samples sent in for analysis using the company’s line of miRview diagnostics.
Next in line behind miRview Squamous, which received approval from the New York State Department of Health Clinical Laboratory Evaluation Program in July (see RNAi News, 7/24/2008), is miRview Mets, a test for determining the source of cancers of unknown primary origin, and miRview Meso, designed to differentiate lung cancer from mesothelioma. Both of these are slated for introduction in 2009.
Completion of the lab also comes about five months after Rosetta closed its $2.9 million acquisition of Clinical Laboratory Improvement Amendments-certified laboratory Parkway Clinical Laboratories, which is based in Pennsylvania (see RNAi News, 7/24/2008). Rosetta billed the transaction as providing the expertise in diagnostic testing and regulatory compliance needed to speed its miRNA-based tests to the market.
Though it was one of the earliest players in the miRNA field, Rosetta isn’t the first to advance a diagnostic based on the small RNAs to the market. In April, Asuragen announced the availability of its first miRNA-based test, designed to differentiate pancreatitis from pancreatic ductal adenocarcinoma in either frozen or formalin-fixed, paraffin-embedded tissue samples (see RNAi News, 4/24/2008).
Although the test was available to clinicians who contacted Asuragen directly, in November, Carol Berry, vice president and general manager of Asuragen Pharmacogenomic Services, told RNAi News that the firm had decided to postpone the formal marketing for the test until November, when additional validation work would be completed (see RNAi News, 10/16/2008).
With that work completed, details about Asuragen’s pancreatic cancer test are now available on the company’s website.
For the third quarter, Rosetta recorded revenues of $705,000, compared with zero revenues in the year-ago quarter. The revenues were entirely generated by Parkway, which Avniel said continues “its routine commercial operations” after its acquisition by Rosetta.
The company’s net loss in the quarter rose to $10.6 million, or $0.88 per share, from $6.4 million, or $0.59 per share, in the same period last year.
Research and development spending in the quarter edged up to $2 million in the quarter from $1.4 million last year. General and administrative costs climbed to $2.6 million from $2 million, while marketing and business development expenses rose to $1.5 million in the third quarter from $1.2 million in same quarter 2007.
As of Sept. 30, Rosetta had cash, cash equivalents, short-term bank deposits, and marketable securities totaling $12.9 million. The company said it expects to burn about $3 million in the fourth quarter of 2008.

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