�Rosetta Genomics, Ltd. (NASDQ: ROSG), a leader in
the development of microRNA-based diagnostic and therapeutic products,
announced the initiation of a clinical validation study with The
University of Texas M. D. Anderson Cancer Center (MDACC). The study testament
focus on Rosetta Genomics' microRNA-based test that identifies the basal
site of cancer of unknown basal (CUP). The study will include ane hundred
patients who are diagnosed with CUP at MDACC, and who meet the eligibility
criteria. Rosetta Genomics expects this test to be submitted for regulatory
approval in the second half of 2008.
"The trigger of this validation study is an integral piece of the
commercialization roadmap for our diagnostic tests, as we advance them
towards usance in a clinical place setting," said Amir Avniel, President and CEO of
Rosetta Genomics. "We believe the initiation of this work for our CUP
assay with a leading genus Cancer research center such as M. D. Anderson attests
to the critical unmet need this test addresses." CUP is a heterogenous
group of cancers that constitutes 3-5% of all cancers with a poor median
survival of 6-10 months(1). Each year, approximately 70,000 patients in the
United States are diagnosed with CUP. A patient role is typically diagnosed with
CUP only after undergoing a broad range of tests, including various tomography
tests such as x-ray, CT, MRI, and PET, which often fail to identify the
origin of the cancer.
Presently, the choice of treatment for metastatic cancer is largely
dependent on the nature of the primary tumor. Patients with CUP pose a
healing dilemma and treatment is often empirical with a "trial and error"
glide path. In the era of rapidly growth effective cytotoxic and targeted
therapies for known cancers, quicker and more precise methods of
identifying the tissue of origin of CUP cases would license the habit of these
therapies, thereby improving the chances of achieving a response and
possibly extending the patient's survival.
"The current gold standard diagnostic evaluation for CUP consists of a
careful story and physical examination, laboratory tests, tomography
studies, invasive studies when necessary, and thorough pathological
evaluation. This process is lengthy and exposes the patient to unnecessary
toxicities," noted Dr. Gauri Varadhachary (M.D. Anderson - Please insert
statute title). "Rosetta Genomics' microRNA-based CUP assay may present an
alternative test to electric current diagnostic practices. This study aims to
validate their assay as well as compare its performance with current tests
for CUP."
About microRNAs
MicroRNAs (miRNAs) are recently ascertained, naturally occurring, small
RNAs that act as master regulators and have the potential to form the basis
for a new class of diagnostics and therapeutics. Since many diseases are
caused by the abnormal activeness of proteins, the power to selectively
regulate protein activity through microRNAs could provide the means to
treat a wide reach of human diseases. In addition, microRNAs have been
shown to have different expression in various pathologic conditions. As a
resultant role, these differences may provide for a novel diagnostic strategy for
many diseases.
About Rosetta Genomics
Rosetta Genomics (Nasdaq: ROSG) is a leader in the plain of microRNAs.
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 lotion of these technologies in the
development of a full grasp of microRNA-based diagnostic and therapeutic
tools, focusing in the first place on crab and various women's health indications.
The first microRNA diagnostic test applying Rosetta Genomics' engineering science
has been approved for clinical use by the State of New York, and the
company expects it will be launched by commissioned clinical laboratories in
the United States in 2008.
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 difference of microRNAs in the diagnosis and treatment of disease and the
Company's ability to successfully develop CUP diagnostic tests, name
forward-looking statements for the purposes of the safe harbor commissariat
under The Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by these advanced
statements as a result of various important factors, including risks
related to: Rosetta's approach to disclose and make grow novel diagnostics
and healing tools, which is unproven and crataegus oxycantha never tether to merchantable
products or services; Rosetta's ability to fund and the results of further
pre-clinical and clinical trials; Rosetta's ability to obtain, maintain and
protect the intellectual property utilized by Rosetta's products; Rosetta's
power to implement its patents against infringers and to defend its patent
portfolio against challenges from tierce parties; Rosetta's ability to
obtain additional funding to support its business activities; Rosetta's
addiction on third parties for development, fabricate, marketing, gross sales,
and dispersion of products; Rosetta's ability to successfully develop its
candidate tools, products and services, all of which are in early stages of
growth; Rosetta's ability to obtain regulatory clearances or approvals
that crataegus laevigata be required for its products and services; the ability to obtain
reporting and adequate payment from health insurers for the products and
services comprising Rosetta's technology; competition from others exploitation
technology like 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 than fully discussed in the "Risk Factors"
section of Rosetta's Annual Report on Form 20-F for the year terminated December
31, 2007 as filed with the Securities and Exchange Commission. In addition,
whatsoever forward-looking statements represent Rosetta's views only as of the
particular date of this release and should non be relied upon as representing its
views as of whatever subsequent date. Rosetta does not take on any responsibility to
update any modern statements unless required by law.
References
(1) Bugat, R., et al., Summary of the Standards, Options and
Recommendations for the management of patients with carcinoma of unknown
primary land site (2002). Br J Cancer, 2003. 89 Suppl 1: p. S59-66.
Rosetta Genomics Ltd
http://www.rosettagenomics.com
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