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As Promised, Rosetta Expands Dx Pipeline With Trio of Cancer, Women’s Health Tests

Rosetta Genomics this week announced that it has moved into its diagnostic pipeline three new microRNA-based tests: one for predicting response to ovarian cancer treatment, one for gauging the risk of gastric cancer recurrence, and one for differentiating small from non-small cell lung cancer.
Rosetta said all three of the new diagnostics are expected to be available between 2009 and 2010, and will be developed and marketed through the company’s own Clinical Laboratory Improvement Amendments-certified laboratory, which it will obtain through the planned $2.9 million acquisition of Parkway Clinical Laboratories (see RNAi News, 6/12/2008).
“Our product engine … is now capable of producing a stream of products that answer unmet medical needs," Amir Avniel, Rosetta’s president and CEO, said in a statement. "We believe that by the end of 2009, we will have established a prominent position in the oncology and women's health fields."
Rosetta also hinted that it may add a colon cancer test to its diagnostic lineup, noting that it has identified microRNA biomarkers in the serum of colon cancer patients that may lead to a blood-based test for colon cancer, but fell short of moving such a program into formal development.
The pipeline additions were widely expected in light of comments by Rosetta executives earlier this year that the company planned to expand its diagnostic portfolio to address new cancer- and women’s health-related indications (see RNAi News, 3/6/2008), but specific details about the tests were not available until now.
Priming the Pipeline
In regards to ovarian cancer, Rosetta said that “platinum-based cytotoxic chemotherapy in conjunction with debulking surgery is currently the gold standard of treatment” for patients with the disease.
Still, between 20 percent and 50 percent of patients do not respond to this therapy and require second-line treatment, Rosetta said. “Furthermore, research suggests that administering platinum-based treatment to patients who subsequently do not respond to it may actually hinder their response to the second-line treatment, as well.”
Recognizing these shortcomings, Rosetta said it has identified “unique microRNA biomarkers” that may help physicians identify ovarian cancer patients more likely to benefit from platinum-based chemotherapy.
Meanwhile, recurrence of gastric cancer after curative resection is believed to occur in 50 percent to 80 percent of patients, Rosetta said. The use of the company’s miRNA molecular classification technology in gastric cancer samples is expected to help predict the risk of recurrence for non-metastatic patients after removal of the primary tumor.
The third test to join Rosetta’s pipeline will address the roughly 200,000 individuals who are diagnosed with lung cancer each year in the US, the company said.
“Before a patient begins lung cancer treatment, an experienced lung cancer pathologist must review the pathologic material,” Rosetta noted. “This is critical because small cell lung cancer, which is generally not treated surgically, can be confused on microscopic examination with non-small cell carcinoma.”
Looking to tap into this need, Rosetta said it has identified unique microRNA biomarkers that may be used to differentiate small from non-small cell lung cancers.
These tests will join Rosetta’s existing diagnostic pipeline, which includes a test for differentiating squamous from non-squamous non-small cell lung cancer that is expected to hit the US market this year, as well as ones for determining the source of cancers of unknown primary origin and differentiating lung adenocarcinoma from mesothelioma.
As reported by RNAi News in May, Rosetta had previously anticipated that it would introduce all three diagnostics in the US during 2008, but now expects only the first will reach the market this year (see RNAi News, 5/22/2008). The other two tests are now only expected to be submitted for regulatory approval in the second half of this year, with the expectation that they will launch sometime in 2009.