Rosetta Genomics Reports Preliminary Data on Discovery of Blood-Based microRNA Signature for Identification and Stratificatio...
July 26 2011 - 8:30AM
Marketwired
Rosetta Genomics (NASDAQ: ROSGD), a leading
developer and provider of microRNA-based molecular diagnostic
tests, today announced preliminary data from a study it conducted
in order to identify a microRNA signature in blood for congestive
heart failure (HF) syndrome and to assess the feasibility to
develop a minimally-invasive, microRNA-based stratification test
for HF.
Demographic and clinical status of HF patients in combination
with indices of cardiac and renal function can identify a large
proportion of high risk patients, however, risk stratification
based on these factors alone remains imprecise, with some high risk
patients not recognized and others inappropriately marked as high
risk. Early identification of patients at higher risk for adverse
events could lead to earlier intervention that could potentially
improve outcomes.
According to leading clinician, Dr. Francis G. Spinale,
Professor and Director, Cardiovascular Translational Research
Center, University of South Carolina School of Medicine, "HF is a
leading cause of hospitalization and death throughout the world,
and new methods for early detection, and thereby early
intervention, for patients at risk for HF is an important area in
cardiovascular medicine. At the recent Scientific Sessions of the
American Heart Association, several presentations were made which
documented the potential utility of microRNA profiling for the
purposes of screening, diagnosis, and prognosis in patients at risk
for developing HF. The findings from this study by Rosetta Genomics
further confirm the potential utility of microRNA profiling as a
blood test for the purposes of improving our capacity to identify,
and hopefully intervene, in patients at risk for HF."
In this proof of concept (POC) study, expression levels of a
wide panel of microRNA were measured in the sera of stable chronic
systolic HF patients and controls. The differences in microRNA
expression between the two groups were characterized and a score,
based on the levels of the 4 microRNAs with the most significant
increase in the HF group, was defined. The score was used to
discriminate HF patients from controls with sensitivity and
specificity of 90%. Moreover, in the HF group, there was a
significant association between the score and important well known
prognostic parameters for HF patients. These preliminary results
show that serum expression levels of microRNAs have the potential
to be utilized to identify heart failure patients and may be useful
for assessing their prognosis.
"The preliminary results from this POC study are very
encouraging as they demonstrate the power of microRNAs expression
in serum to serve as diagnostic and prognostic markers for HF.
Importantly, the study showed that within HF patients, it can
distinguish between key prognostic parameters which may be
particularly useful for determining risk stratification, an
important factor for guiding therapy and patient monitoring,"
stated Kenneth A. Berlin, President and CEO of Rosetta Genomics.
"We look forward to furthering our validation of these potentially
powerful biomarkers for the identification and risk stratification
of HF patients. A blood-based microRNA diagnostic could provide
important clinical information to guide treatment decisions for HF
patients in a non-invasive and cost effective manner."
About Heart Failure: Heart Failure (HF) is
a complex clinical syndrome that can result from any structural or
functional cardiac disorders that impairs the ability of the
ventricles to fill with or eject blood. It is the most prevalent
disease in the Western world and the only cardiovascular disease
whose prevalence continues to rise. It is estimated that 5 million
Americans are diagnosed with HF and there are approximately 500,000
new patients each year. Besides its high prevalence, heart failure
is also the most expensive disease in the western countries. The
American Heart Association estimates from 2004 showed that over $26
billion dollars per year was spent on heart failure.
About miRview® Products miRview® are a
series of microRNA-based diagnostic products offered by Rosetta
Genomics. miRview® mets and miRview® mets² accurately identify the
primary tumor site in metastatic cancer and 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® lung accurately identifies the four
main subtypes of lung cancer using small amounts of tumor cells.
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 U.S. alone, Rosetta
Genomics estimates that approximately 200,000 patients a year may
benefit from the miRview® mets and miRview® mets² test, 60,000 from
miRview® squamous and 60,000 from miRview® meso. 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 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 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
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 the potential for microRNA expression in
serum to serve as diagnostic and prognostic markers for heart
failure, and the potential of microRNAs for patient selection and
in the diagnosis and treatment of disease, 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; 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, 2010 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 Ken Berlin President
& CEO (215) 382-9000 ext. 326 investors@rosettagenomics.com
Investor Contacts: Lippert/Heilshorn & Associates Anne
Marie Fields (212) 838-3777 afields@lhai.com or Bruce Voss (310)
691-7100 bvoss@lhai.com
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