Medicare Administrator Issues Final Local Coverage Determination for Rosetta
Cancer Origin Test™
microRNA assay determined reasonable and necessary for providing an important
niche in pathologic diagnoses of Cancer of Unknown Primary
PHILADELPHIA and REHOVOT, Israel, June 13, 2013
PHILADELPHIA and REHOVOT, Israel, June 13, 2013 /PRNewswire/ --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-baseddiagnostic 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® mets^2, 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.
About Rosetta Cancer Testing Services (formerly the miRview^® product line)
Rosetta Cancer Tests are a series of microRNA-based diagnostic testing
services offered by Rosetta Genomics. The Rosetta Cancer Origin Test™ can
accurately identify the primary tumor type in primary and metastatic cancer
including cancer of unknown or uncertain primary (CUP). Rosetta Mesothelioma
Test™ diagnoses mesothelioma, a cancer connected to asbestos exposure. The
Rosetta Lung Cancer Test™ accurately identifies the four main subtypes of lung
cancer using small amounts of tumor cells. The Rosetta Kidney Cancer Test™
accurately classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma.
Rosetta's assays are designed to provide objective diagnostic data; it is the
treating physician's responsibility to diagnose and administer the appropriate
treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000
patients a year may benefit from the Rosetta Cancer Origin Test™, 60,000 from
the Rosetta Mesothelioma Test™, 65,000 from the Rosetta Kidney Cancer Test™
and 226,000 patients from the Rosetta Lung Cancer Test™. The Company's assays
are offered directly by Rosetta Genomics in the U.S., and through distributors
around the world. For more information, please visit www.rosettagenomics.com.
Parties interested in ordering the test can contact Rosetta Genomics at (215)
382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of microRNA-based molecular
diagnostics. Founded in 2000, Rosetta's integrative research platform
combining bioinformatics and state-of-the-art laboratory processes has led to
the discovery of hundreds of biologically validated novel human microRNAs.
Building on its strong patent position and proprietary platform technologies,
Rosetta is working on the application of these technologies in the development
and commercialization of a full range of microRNA-based diagnostic tools.
Rosetta's cancer testing services are commercially available through its
Philadelphia-based CAP-accredited, CLIA-certified lab. Frost & Sullivan
recognized Rosetta Genomics with the 2012 North American Next Generation
Diagnostics Entrepreneurial Company of the Year Award.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future expectations,
plans and prospects, including without limitation, Rosetta's Cancer of Origin
Test™, Rosetta's development or commercialization of molecular diagnostics,
the market acceptance of Rosetta's cancer testing services,particularly the
Rosetta Cancer Origin Test™, Rosetta's development of personalized medicine
products and services and Rosetta achieving and maintaining Medicare coverage
for its' testsconstitute forward-looking statements for the purposes of the
safe harbor provisions under The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by these
forward-looking statements as a result of various important factors, including
those risks more fully discussed in the "Risk Factors" section of Rosetta's
Annual Report on Form 20-F for the year ended December 31, 2012as filed with
the SEC. In addition, any forward-looking statements represent Rosetta's views
only as of the date of this release and should not be relied upon as
representing its views as of any subsequent date. Rosetta does not assume any
obligation to update any forward-looking statements unless required by law.
Ken Berlin, President & CEO
(215) 382-9000, ext. 326
Anne Marie Fields
SOURCE Rosetta Genomics Ltd.
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