Pricing Commensurate With the Assay's Clinical Value and Consistent With Other High-Value, Clinical Assays
PHILADELPHIA, PA and REHOVOT, ISRAEL, Jun 19, 2012 (MARKETWIRE via COMTEX) --Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based molecular diagnostic tests, today
announced that the designated Medicare Administrative Contractor
("MAC") for the Company's miRview(R) mets^2 assay has determined the
assay to be reasonable and necessary for the diagnosis of cancers of
unknown origin in a specified setting and has established a
reimbursement rate for the assay. The coverage decision can be found
at the following link:
https://www.novitas-solutions.com/bulletins/all/news-06152012.html.
The miRview(R) mets2 assay accurately identifies the primary tumor of
origin in primary and metastatic cancer including Cancer of Unknown
or Uncertain Primary ("CUP").
"This is another critical commercial milestone for Rosetta Genomics
as equitable reimbursement is one of the key drivers for clinical and
commercial adoption of the technology. We are pleased with the
coverage and the reimbursement amount that the designated MAC has
established. The reimbursement amount is commensurate with the
clinical value of miRview(R) mets^2 and is consistent with assays of
similarly high clinical value," noted Kenneth A. Berlin, President
and Chief Executive Officer of Rosetta Genomics. "New tumor specific
and molecularly-targeted oncology drugs are driving the need for
accurate identification and classification of tumor types in order to
optimize treatment and improve patient outcomes. With approximately
180,000-220,000 CUP patients per year in the U.S., this represents a
large market opportunity for Rosetta Genomics."
About miRview(R) Products
miRview(R) are a series of microRNA-based
diagnostic products offered by Rosetta Genomics. miRview(R) mets^2
accurately identifies the primary tumor type in primary and
metastatic cancer including Cancer of Unknown Primary (CUP).
miRview(R) squamous accurately identifies the squamous subtype of
non-small cell lung cancer, which carries an increased risk of severe
or fatal internal bleeding and poor response to treatment for certain
therapies. miRview(R) meso diagnoses mesothelioma, a cancer connected
to asbestos exposure. miRview(R) lung accurately identifies the four
main subtypes of lung cancer using small amounts of tumor cells.
miRview(R) kidney accurately classifies the four most common kidney
tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC,
Chromophobe RCC and Oncocytoma. miRview(R) tests 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 miRview(R) mets^2 test, 60,000 from
miRview(R) squamous, 60,000 from miRview(R) meso, 54,000 from
miRview(R) kidney and more than 1 million patients worldwide from
miRview(R) lung. The Company's tests are offered directly by Rosetta
Genomics in the U.S., and through distributors around the globe. For
more information, please visit www.mirviewdx.com. Parties interested
in ordering the test can contact Rosetta Genomics at (215) 382-9000
ext. 309.
About Rosetta Genomics
Rosetta Genomics develops and commercializes
a full range of microRNA-based molecular diagnostics. Founded in
2000, the Company'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 Genomics is working on the application
of these technologies in the development and commercialization of a
full range of microRNA-based diagnostic tools. The Company's
miRview(R) product line is commercially available through its
Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more,
please visit www.rosettagenomics.com.
Forward-Looking Statements
Various statements in this release
concerning Rosetta's future expectations, plans and prospects,
including without limitation, statements relating to equitable
reimbursement being one of the key drivers for clinical and
commercial adoption of the technology and the potential market
opportunity for Rosetta's tests, constitute 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 risks
related to: Rosetta's approach to discover microRNA technology and to
work on the application of this technology in the development of
novel diagnostics and therapeutic tools, which may never lead to
commercially accepted products or services; Rosetta's ability to
obtain, maintain and protect its intellectual property; Rosetta's
ability to enforce its patents against infringers and to defend its
patent portfolio against challenges from third parties; Rosetta's
need and ability to obtain additional funding to support its business
activities; Rosetta's dependence on third parties for development,
manufacture, marketing, sales, and distribution of products;
Rosetta's ability to successfully develop its products and services;
Rosetta's ability to obtain regulatory clearances or approvals that
may be required for its products and services; Rosetta's ability to
obtain coverage and adequate payment from health insurers for the
products and services comprising Rosetta's technology; Rosetta's
ability to obtain a formal agreement for Medicare coverage and to
maintain an equitable reimbursement valuation; competition from
others using technology similar to Rosetta's and others developing
products for similar uses; Rosetta's dependence on collaborators;
Rosetta's ability to successfully market its products and services;
and Rosetta's short operating history; as well as 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, 2011 as filed
with the Securities and Exchange Commission. 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.
Company Contact:
Rosetta Genomics Ltd.
Ken Berlin
President & CEO
(215) 382-9000 ext. 326
investors@rosettagenomics.com
Investor Contacts:
LHA
Anne Marie Fields
(212) 838-3777
afields@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
@LHA_IR_PR
SOURCE: Rosetta Genomics, Ltd.
mailto:investors@rosettagenomics.com
mailto:afields@lhai.com
mailto:bvoss@lhai.com