Rosetta (ROSG) Higher on Cancer Origin Test Data
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Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that Novitas Solutions, the designated Medicare Administrative Contractor (MAC) for the Company's microRNA-based diagnostic assays, has issued for notice the final revised Local Coverage Determination (LCD) for Biomarkers in Oncology, which includes the Rosetta Cancer Origin Test™, the Rosetta Lung Cancer Test™ and the Rosetta Kidney Cancer Test™ (formerly miRview® mets2, lung and kidney assays). The LCD will become effective as of August 1, 2013.
The final revised LCD confirms continued Medicare coverage for the Cancer Origin Test to identify Cancer of Unknown or Uncertain Primary (CUP) as originally reported in Novitas' bulletin posted in June 2012, and for which they have been reimbursing the test at approximately $3,500 per test.
This final policy determination was based on peer-reviewed publications from clinical studies conducted internally at Rosetta Genomics and at world-renowned institutions that demonstrated the test's clinical utility.
"The affirmed Medicare reimbursement and formal coverage determination is good news for patients and physicians grappling with a CUP diagnosis. The published policy provides continued Medicare reimbursement and enables us to provide the Cancer Origin Test to the 45 million Medicare beneficiaries throughout the U.S. at no cost to the patient, thereby eliminating an adoption barrier for the physician ordering the test and for the patient. Together with our recent credentialing agreements with two large U.S. Preferred Provider Organizations, the total number of covered lives and for which our Cancer Origin Test could be adjudicated as 'in-network' now exceeds 61 million, which means that one-in-five Americans are covered for the Rosetta Cancer Origin Test," said Kenneth A. Berlin President and Chief Executive Officer of Rosetta Genomics.
"Importantly, this LCD affirms that our test is reasonable and necessary for providing an important niche in the pathologic diagnoses of CUP. With more than 200,000 patients per year presenting with Cancer of Unknown or Uncertain Primary, and who may benefit from our Cancer Origin Test, this coverage reflects the importance of determining the tumor origin in hard-to-diagnose metastatic cancers and CUP. This is particularly important as new, molecularly-targeted cancer treatments are developed. We believe our Cancer Origin Test helps physicians to accurately diagnose tumor origin in order to optimize treatment," he added.
The Company reports that in the LCD, Novitas still considers the Rosetta Lung Cancer Test and the Rosetta Kidney Cancer Test investigational and, as such, will not include those tests for Medicare coverage at this time.
"We continue to build the body of clinical data in support of the utility of our Lung Cancer Test and our Kidney Cancer Test in sub-classifying tumor types. We believe that additional clinical data and peer-reviewed publications will support a favorable reimbursement decision for these tests in the future," he concluded.
The final revised LCD confirms continued Medicare coverage for the Cancer Origin Test to identify Cancer of Unknown or Uncertain Primary (CUP) as originally reported in Novitas' bulletin posted in June 2012, and for which they have been reimbursing the test at approximately $3,500 per test.
This final policy determination was based on peer-reviewed publications from clinical studies conducted internally at Rosetta Genomics and at world-renowned institutions that demonstrated the test's clinical utility.
"The affirmed Medicare reimbursement and formal coverage determination is good news for patients and physicians grappling with a CUP diagnosis. The published policy provides continued Medicare reimbursement and enables us to provide the Cancer Origin Test to the 45 million Medicare beneficiaries throughout the U.S. at no cost to the patient, thereby eliminating an adoption barrier for the physician ordering the test and for the patient. Together with our recent credentialing agreements with two large U.S. Preferred Provider Organizations, the total number of covered lives and for which our Cancer Origin Test could be adjudicated as 'in-network' now exceeds 61 million, which means that one-in-five Americans are covered for the Rosetta Cancer Origin Test," said Kenneth A. Berlin President and Chief Executive Officer of Rosetta Genomics.
"Importantly, this LCD affirms that our test is reasonable and necessary for providing an important niche in the pathologic diagnoses of CUP. With more than 200,000 patients per year presenting with Cancer of Unknown or Uncertain Primary, and who may benefit from our Cancer Origin Test, this coverage reflects the importance of determining the tumor origin in hard-to-diagnose metastatic cancers and CUP. This is particularly important as new, molecularly-targeted cancer treatments are developed. We believe our Cancer Origin Test helps physicians to accurately diagnose tumor origin in order to optimize treatment," he added.
The Company reports that in the LCD, Novitas still considers the Rosetta Lung Cancer Test and the Rosetta Kidney Cancer Test investigational and, as such, will not include those tests for Medicare coverage at this time.
"We continue to build the body of clinical data in support of the utility of our Lung Cancer Test and our Kidney Cancer Test in sub-classifying tumor types. We believe that additional clinical data and peer-reviewed publications will support a favorable reimbursement decision for these tests in the future," he concluded.
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