Rosetta Genomics Names Genetic Technologies Limited Exclusive Distributor for Rosetta’s microRNA-based Assays in Australia,...
October 22 2009 - 7:30AM
Business Wire
Rosetta Genomics, Ltd. (NASDAQ:ROSG), a leading developer of
microRNA-based molecular diagnostics, and Genetic Technologies
Limited (GTG) (NASDAQ:GENE) (ASX:GTG), the leading private genetic
testing laboratory in Australia, announced today the signing of an
exclusive distribution agreement for Rosetta Genomics’ three
currently available diagnostic tests. Under the terms of the
agreement, GTG will market Rosetta Genomics’ miRview™ tests in
Australia, New Zealand and Singapore. Further financial terms were
not disclosed.
“We have made remarkable progress in making our tests so widely
available in the short time since they were launched early this
year,” said Ronen Tamir, Chief Commercialization Officer of Rosetta
Genomics. “We note that this distribution agreement marks Rosetta
Genomics’ first entry into the Pacific Rim and represents the fifth
continent on which our miRview™ tests will be sold.”
Mr. Tamir added, “Genetic Technologies is the leading marketer
of genetic tests for a host of indications, including breast
cancer, in Oceania. In addition, distinguishing mesothelioma from
other lung cancers may be a particularly important task in
Australia, where the mining industry is a key component of the
country’s economy. We are very excited to be working with GTG to
improve patient care.”
Paul MacLeman, Chief Executive Officer of Genetic Technologies,
said, “This is an important first step in Genetic Technologies’
move from predictive gene tests into advanced cancer management. We
are seeking to leverage in-house developed tests through partnering
with third party developers of novel tests. Through this approach,
the company is aiming to rapidly build a comprehensive portfolio of
genetic tools enabling oncologists to more effectively manage
patient diagnosis and therapy, which may improve treatment
outcomes. Genetic Technologies is very excited to announce its
relationship with Rosetta Genomics, an acknowledged leader in the
area of microRNA diagnostic test development.”
The following tests will be distributed by Genetic
Technologies:
- miRview™ mets – This test can
accurately identify the primary tumor site in patients presenting
with metastatic cancer, as well in patients whose tumor 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. When
administered targeted therapy, whether currently available or under
development, 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 non-small cell lung
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 microRNA’s high specificity as biomarkers to
differentiate mesothelioma, a cancer connected to asbestos
exposure, from other carcinomas in the lung. 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 identify from other
cancers. 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. MicroRNAs’ unique advantage 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.
It has been suggested that their small size (19-21 nucleotides)
enables them to remain intact in FFPE blocks, as opposed to
messenger RNA (mRNA), which tends to rapidly degrade in samples
preserved by this method. 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 (NSCLC), 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 (NASDAQ:ROSG) 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 IP 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 CLIA-certified lab. Rosetta Genomics is the 2008
winner of Wall Street Journal’s Technology Innovation Awards in the
medical/biotech category. To learn more, please visit
www.rosettagenomics.com.
About Genetic Technologies Limited
Genetic Technologies (ASX:GTG) (NASDAQ Global Market: GENE)
specializes in licensing, genetic testing and research. GTG’s
exclusive access to a wide range of genetic tests enables it to
expand its testing services throughout the Asia-Pacific region. The
Company is the leading private provider of molecular diagnostics
for cancer susceptibility in Australia and is seeking to build on
this position through strategic relationships. GTG’s pipeline of
innovative research projects will potentially add considerable
further value to its licensing and genetic testing businesses.
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, 2008 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.
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