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M. D. Anderson To Initiate Clinical Validation Study On Rosetta Genomics' MicroRNA-based Diagnostic Assay Identifying The Origin Of Cancer Metastases
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 will
focus on Rosetta Genomics' microRNA-based test that identifies the primary
site of cancer of unknown primary (CUP). The study will include one 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 initiation of this validation study is an integral part of the
commercialization roadmap for our diagnostic tests, as we advance them
towards use in a clinical setting," said Amir Avniel, President and CEO of
Rosetta Genomics. "We believe the initiation of this study for our CUP
assay with a leading cancer research center such as M. D. Anderson attests
to the critical unmet need this test addresses." CUP is a heterogeneous
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 is typically diagnosed with
CUP only after undergoing a wide range of tests, including various imaging
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
therapeutic dilemma and treatment is often empiric with a "trial and error"
approach. In the era of rapidly growing effective cytotoxic and targeted
therapies for known cancers, quicker and more accurate methods of
identifying the tissue of origin of CUP cases would permit the use 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 history and physical examination, laboratory tests, imaging
studies, invasive studies when necessary, and thorough pathologic
evaluation. This process is lengthy and exposes the patient to unnecessary
toxicities," noted Dr. Gauri Varadhachary (M.D. Anderson - Please insert
title). "Rosetta Genomics' microRNA-based CUP assay may present an
alternative test to 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 discovered, 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 activity of proteins, the ability to selectively
regulate protein activity through microRNAs could provide the means to
treat a wide range of human diseases. In addition, microRNAs have been
shown to have different expression in various pathological conditions. As a
result, these differences may provide for a novel diagnostic strategy for
many diseases.
About Rosetta Genomics
Rosetta Genomics (Nasdaq: ROSG) is a leader in the field 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 application of these technologies in the
development of a full range of microRNA-based diagnostic and therapeutic
tools, focusing primarily on cancer and various women's health indications.
The first microRNA diagnostic test applying Rosetta Genomics' technology
has been approved for clinical use by the State of New York, and the
company expects it will be launched by licensed 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 of microRNAs in the diagnosis and treatment of disease and the
Company's ability to successfully develop CUP diagnostic 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 and develop novel diagnostics
and therapeutic tools, which is unproven and may never lead to marketable
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
ability to enforce its patents against infringers and to defend its patent
portfolio against challenges from third parties; Rosetta's 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, all of which are in early stages of
development; 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, 2007 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.
References
(1) Bugat, R., et al., Summary of the Standards, Options and
Recommendations for the management of patients with carcinoma of unknown
primary site (2002). Br J Cancer, 2003. 89 Suppl 1: p. S59-66.
Rosetta Genomics Ltd
http://www.rosettagenomics.com
MD Anderson a iniþia Clinic de validare Studiu privind Rosetta genomicã "MicroRNA pe baza de test de diagnosticare a Identificarea originea de cancer metastaze - M. D. Anderson To Initiate Clinical Validation Study On Rosetta Genomics' MicroRNA-based Diagnostic Assay Identifying The Origin Of Cancer Metastases - articole medicale engleza - startsanatate