NEW YORK (GenomeWeb) – Rosetta Genomics has initiated a patient registry study for its Cancer Origin Test, the company announced this week.
The company set up the registry in an effort to track the treatment decisions physicians make for their cancer patients based on the test results, as well as the therapeutic strategy they decide upon, the duration of patients' responses, survival, and other clinically relevant data. The registry is hoping to track this information for 400 patients diagnosed with cancer of unknown or uncertain primary or metastatic disease of unknown origin.
The microRNA-based Cancer Origin Test can identify the origin of a primary and metastatic tumor.
Market research firm MedPanel will conduct the study for Rosetta with institutional review board approval at multiple clinical sites around the world. Initial data from the trial is slated for the second half of 2015, while the study continues to enroll patients for the next three-to-four years, including two years additional follow-up for survivors.
"The analytical and diagnostic performance of the Cancer Origin Test has been demonstrated in multiple studies," Rosetta said in a statement. The company claims that its Cancer Origin Test predicts the primary origin of a tumor from a tissue sample with 90 percent sensitivity and 99 percent specificity.
With the latest study, Rosetta is hoping to spur acceptance among payors and spur reimbursement for the Cancer Origin Test. "This registry could allow us to gather important patient data to compare the impact of treatment in specific subsets of CUP patients," Rosetta CEO Kenneth Berlin said in a statement. "The results from COPR are expected to underscore the value proposition for the Cancer Origin Test, and to provide real-world data in support of continued adoption and reimbursement."
Earlier this year, the company signed an agreement to provide the Cancer Origin Test within MultiPlan's system, which has more than 900,000 providers and 67 million people in its network. Rosetta also has a deal with Highmark Health Services for coverage of the test.
Rosetta estimates that 200,000 patients a year can benefit from this test.