Rosetta Genomics, Ltd. (NASDQ:ROSG), a leading developer of
microRNA-based molecular diagnostics, and Genekor S.A, a leading
molecular diagnostic service provider in Greece, announced today the
signing of an exclusive distribution agreement for three of Rosetta
Genomics' diagnostic tests in Greece.
?We are very pleased to be partnering with Genekor to distribute our
miRview? tests in Greece,? said Kenneth A. Berlin, President and CEO of
Rosetta Genomics. ?Over the years, Genekor has established itself as a
leading molecular diagnostic company in Greece, and has relevant
experience in distributing high-complexity molecular diagnostic tests in
the oncology field. This is our second distribution agreement in Europe,
and we plan to expand our distribution network to other European
countries this year.?
The following tests will be distributed by Genekor S.A:
-
miRview? mets – This test
can accurately identify the primary tumor site in patients presenting
with metastatic cancer, as well as in patients whose tumor origin has
not been identified, and consequently been labeled Cancer of Unknown
Primary (CUP). As metastases need to be treated according to their
primary origin, accurate identification of the metastases' primary
origin can be critical for determining appropriate treatment. Current
diagnostic methods to identify the origin of a metastasis include a
wide range of costly, time consuming and, at times, inefficient tests. miRview?
mets offers physicians a fast, accurate and easy-to-interpret
diagnosis of the predicted primary origin.
-
miRview? squamous – Using
a single microRNA, miRview? squamous differentiates squamous from
non-squamous, non-small cell lung cancer (NSCLC) patients. This has
become more important as the new molecularly-targeted therapies and
those in development when administered to patients with squamous cell
carcinoma of the lung have demonstrated varying response patterns
ranging from a high incidence of severe or fatal internal bleeding in
the lungs to overall poor response to treatment. Current methods for
differentiating squamous from non-squamous NSCLC cancer are not
standardized, are difficult to reproduce and have low accuracy. miRview
squamous produces a single score that indicates whether a sample
is squamous or non-squamous NSCLC.
-
miRview? meso – This
test leverages microRNAs' high specificity as biomarkers to
differentiate mesothelioma, a cancer connected to asbestos exposure,
from carcinomas in the lung or pleura. As mesothelioma patients
require specific treatment regimens, an accurate diagnosis is
critical. Currently, there is no single diagnostic test that is
entirely conclusive for this differentiation. In addition,
pathological diagnosis may suffer from significant inter-observer
variability, and, in the absence of a single specific and reliable
marker, mesothelioma can be difficult to differentiate from
carcinomas. miRview? meso is a highly accurate test that may
also assist physicians to rule out mesothelioma in patients diagnosed
with adenocarcinoma in the lung who have been exposed to
mesothelioma-related substances, primarily asbestos particles and
heavy metals.
About microRNAs
MicroRNAs (miRNAs) are recently discovered, small RNAs that act as
master regulators of protein synthesis, and have been shown to be highly
effective biomarkers. The unique advantage of microRNAs as biomarkers
lies in their high tissue specificity, and their exceptional stability
in the most routine preservation methods for biopsies, including
Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle
aspirate (FNA) cell blocks. It has been suggested that their small size
(19 to 21 nucleotides) enables them to remain intact in FFPE blocks, as
opposed to messenger RNA (mRNA), which tends to degrade rapidly. In
addition, early preclinical data has shown that by controlling the
levels of specific microRNAs, cancer cell growth may be reduced. To
learn more about microRNAs, please visit www.rosettagenomics.com.
About miRview? Products
miRview? are a series of microRNA-based diagnostic products offered by
Rosetta Genomics. miRview? mets accurately identifies the primary tumor
site in metastatic cancer and Cancer of Unknown Primary (CUP). miRview?
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?
meso diagnoses mesothelioma, a cancer connected to asbestos exposure.
miRview? tests are designed to provide objective diagnostic data; it is
the treating physician's responsibility to diagnose and administer the
appropriate treatment. In the US alone, over 100,000 patients a year may
benefit from the miRview? mets test, 60,000 from miRview? squamous, and
60,000 from miRview? meso, with similar numbers of patients outside the
US. The company's tests are now being offered through distributors
around the globe. For more information, please visit www.mirviewdx.com.
About Rosetta Genomics
Rosetta Genomics is a leading developer 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 of a full range of
microRNA-based diagnostic tools. The company's first three
microRNA-based tests, miRview? squamous, miRview? mets and miRview?
meso, are commercially available through its Philadelphia-based
CAP-accredited, CLIA-certified lab. Rosetta Genomics is the 2008 winner
of the Wall Street Journal's Technology Innovation Awards in the
medical/biotech category. To learn more, please visit www.rosettagenomics.com.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future
expectations, plans and prospects, including without limitation,
statements relating to the role of microRNAs in human physiology and
disease, the potential of microRNAs in the diagnosis and treatment of
disease, and Rosetta's expected expansion of its global distribution
network 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 candidate tools,
products and services; Rosetta's ability to obtain regulatory clearances
or approvals that may be required for its products and services; the
ability to obtain coverage and adequate payment from health insurers for
the products and services comprising Rosetta's technology; competition
from others using technology similar to Rosetta's and others developing
products for similar uses; Rosetta's dependence on collaborators; 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, 2009 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.
Rosetta Genomics Company Contact:
Ron
Kamienchick, 215-382-9000 ext 318
investors@rosettagenomics.com
or
Investor
Contacts:
Lippert/Heilshorn & Associates
Anne Marie
Fields, 212-838-3777
afields@lhai.com
Bruce
Voss, 310-691-7100
bvoss@lhai.com
or
Genekor
S.A Contacts:
Nikolaos Tsoulos
Chief Executive
Officer
Phone: (+30) 210 603 2138
E-mail: : ntsoulos@genekor.com
