Test Developed and Validated by Columbia University Medical Center Based
on Rosetta Genomics' Proprietary MicroRNA Technology
The Test Differentiates Squamous From Non-Squamous Non-Small Cell Lung
Cancer (NSCLC), Classifying Squamous-Cell Carcinoma of the Lung With
Sensitivity of 96 Percent and Specificity of 90 Percent
This is the First CLIA Approved Test Which Leverages MicroRNAs'
Sensitivity as Biomarkers for Accurate Diagnosis of Lung Cancer
REHOVOT, Israel and JERSEY CITY, New Jersey, July 22
/PRNewswire-FirstCall/ -- Rosetta Genomics, Ltd. (NASDQ: ROSG) announces
today that the first molecular test based on Rosetta Genomics' proprietary
microRNA technology, developed and validated by Columbia University Medical
Center (CUMC), has been approved for clinical use by the New York State
Department of Health Clinical Laboratory Evaluation Program. CUMC is now
finalizing the commercial aspects of this test and will announce its clinical
availability to patients nationwide once details are finalized later this
year.
"This is a landmark event for us, marking the first step in the
transformation of Rosetta Genomics into a commercial diagnostics company,"
said Amir Avniel, President and CEO of Rosetta Genomics. "Our proprietary
microRNA platform technologies, which this test is based on, have enabled
Columbia University Medical Center's High Complexity Molecular Pathology
Laboratory to develop a highly sensitive and specific test, which is a key
for optimal administration of targeted therapies for this devastating cancer.
As we move forward, we expect our development engines to enable the launch of
additional tests based on our technology that have the potential to improve
patient care worldwide."
The test, performed on a sample of a patient's tumor, classifies
squamous-cell carcinoma of the lung with sensitivity of 96 percent and
specificity of 90 percent. This is the first test utilizing microRNAs' unique
sensitivity and specificity as biomarkers that may offer a standardized and
objective method for lung cancer classification.
"We value our partnership with Columbia University Medical Center and we
look forward to continuing this collaboration," noted Ronen Tamir, Chief
Commercial Officer at Rosetta Genomics. "At the same time, once we complete
the previously announced acquisition of Parkway Clinical Laboratories, Inc.
in Pennsylvania, we plan to complement CUMC's commercial efforts by
submitting the same type of test, developed and validated by Rosetta, for
regulatory approval in the 4th quarter of 2008."
The advent of targeted lung cancer therapies directed at specific
cellular alterations now demands the most accurate classification possible
for non-small cell lung carcinomas (NSCLC). A recently approved angiogenesis
inhibitor (bevacizumab(1)) for NSCLC has been shown to be less effective
against squamous-cell lung cancer. Furthermore, this targeted therapy
includes a black-box warning about substantially higher rates of severe or
fatal hemorrhage among patients with squamous NSCLC histology compared with
non-squamous NSCLC. This has led squamous-cell histology to be regarded by
many as an exclusion criterion for this drug. In addition, several other
targeted drugs for NSCLC currently under development may require this type of
sensitive differentiation.
Approximately 185,000 people are diagnosed with Non Small Cell Lung
Cancer each year in the United States, with an estimated 60,000 patients per
year potential candidates for targeted therapy with bevacizumab in the United
States.
Data presented in peer reviewed publications has shown that two blinded
expert observers, when asked to give an independent histological
classification of NSCLC, agreed only 74.7 percent of the time. Furthermore,
sensitivity for squamous cell carcinoma was only 70.9 percent(2). A second
study(3) looking at classification of squamous cell carcinoma showed that 40
percent of samples diagnosed as squamous-cell lung cancer at regional labs
were later reclassified as other lung cancers at central labs.
Rosetta Genomics expects two additional tests based on its microRNA
technology to be validated and submitted for regulatory approval during the
second half of 2008 by laboratories in the United States. One test is
designed to differentiate mesothelioma, an asbestos-associated cancer that
develops in the pleura, from adenocarcinomas that either arise in the lung or
spread to the lung and pleura from other sites. Another test is designed to
identify the origin of a metastasis in patients presenting with cancer of
unknown primary (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 microRNA.
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 test based on the company's technology, differentiating squamous
from non squamous non small cell lung cancer, is now approved through
Columbia University Medical Center's High Complexity Molecular Pathology
Laboratory. In Addition, the company expects two additional microRNA
diagnostic tests applying its technology will be validated and submitted for
regulatory approval 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, the
expected timing of submission for approval and launch of diagnostic tests
using our microRNA technology and the expectation that Rosetta will submit
its own diagnostic test to differentiate squamous from non-squamous NSCLC in
the fourth quarter of 2008 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 is unproven and
may never lead to marketable 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, 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.
(1) Avastin(TM), a registered trademark of Genentech, Inc.
(2) Field RW, Smith BJ, Platz CE, Robinson RA, Neuberger JS, Brus CP, et
al. Lung cancer histologic type in the Surveillance, epidemiology, and end
results registry versus independent review. J Natl Cancer Inst 2004;96:1105--7
(3) Andreas Stang ,Hermann Pohlabeln , Klaus M.Muller ,Ingeborg Jahn ,
Klaus Giersiepen, Karl-Heinz Jockel Diagnostic agreement in the
histopathological evaluation of lung cancer tissue in a population-based
case-control study. Lung Cancer (2006) 52 ,29 --36
Contact:
Media& Investors
Ron Kamienchick
T: +1-646- 509 1893
E: investors@rosettagenomics.com
SOURCE Rosetta Genomics Ltd
-0- 07/22/2008
/CONTACT: Contact:, Media& Investors, Ron Kamienchick, T: +1-646- 509
1893, E: investors@rosettagenomics.com/
(ROSG)
CO: Rosetta Genomics Ltd
ST: New Jersey, Israel
IN: FIN BIO HEA MTC
SU: TRI
UK
-- UKTU001 --
7041 07/22/2008 08:30 EDT http://www.prnewswire.com