Columbia University Medical Center and Rosetta Genomics Announce Columbia University's...

Columbia University Medical Center and Rosetta Genomics Announce Columbia
University's Submission of the First Cancer Diagnostic Test Based on Rosetta
Genomics Proprietary MicroRNA Technology for Approval to the New York State
Department of Health Clinical Laboratory Evaluation Program
The Laboratory-Developed Test is Designed to Differentiate 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.

REHOVOT, Israe and JERSEY CITY, New Jersey and NEW YORK, April 3
/PRNewswire-FirstCall/ -- Rosetta Genomics, Ltd. (NASDQ: ROSG) and Columbia
University Medical Center (CUMC) announced today that the first molecular
test based on Rosetta Genomics' proprietary microRNA technology, developed by
CUMC, has been submitted for approval by the New York State Department of
Health. The test is designed to differentiate squamous from non-squamous
NSCLC and is the first to use this technology to successfully classify two
distinct types of the most common form of lung cancer.
Once approved by New York State Department of Health, the test will be
made available nationwide through Columbia University Medical Center's High
Complexity Molecular Pathology Laboratory, a laboratory licensed to use
nucleic acids for better diagnosis of various cancers, which is part of the
Department of Pathology and Cell Biology at CUMC.
"With advancements toward more targeted therapies for cancer, there is a
growing need for better diagnostics," said Amir Avniel, President and CEO of
Rosetta Genomics.
The test, performed on a sample of the patient's tumor and validated by
Columbia University Medical Center, classifies squamous cell carcinoma of the
lung with specificity of 90 percent and sensitivity of 96 percent. This is
the first test utilizing microRNAs' unique sensitivity and specificity as
biomarkers that may offer a standardized and objective method for cancer
classification.
The genetic classification can be especially important for selecting
proper treatment as therapies have been shown to act differently depending on
cancer type, such as the case between squamous (scalelike) and non-squamous
non-small cell lung cancer (NSCLC). Approximately 185,000 people are
diagnosed with either squamous or non-squamous NSCLC each year in the United
States.
"The importance of accurately differentiating squamous cell from
non-squamous NSCLC has recently been an issue of great interest and is
gaining importance as new targeted therapies for NSCLC enter the market or
proceed to late stages of development," said Dr. Dalia Cohen, chief
scientific officer of Rosetta Genomics. "This is a great advancement in terms
of physicians' ability to better treat patients with targeted therapies,
which are currently highly effective in some patients while being less
effective and sometimes harmful for others."
"We are excited to have performed the validation of the first diagnostic
test based on microRNAs, and believe this endeavor is an important next step
in bringing better diagnostics to patients and physicians," noted Dr. Mahesh
Mansukhani, director of the Molecular Pathology Laboratory at Columbia
University Medical Center, who has led the validation process and submission
of the test to the New York State Department of Health for approval. "Using a
single microRNA biomarker, the test demonstrates high sensitivity and
specificity, for squamous differentiation. Once approved, we will be pleased
to offer this test through our pathology laboratory nationwide to doctors and
patients as an objective aid in the classification of NSCLC. "
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.
The ability of physicians to accurately differentiate squamous
(scalelike) from non-squamous NSCLC is an important treatment guide.
Bevacizumab(4), an angiogenesis inhibitor and an important new modality of
therapy for non-squamous NSCLC, 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.
Currently, an estimated 60,000 patients per year are potential candidates
for targeted therapy with Avastin(TM), a market available angiogenesis
inhibitor, in the United States.
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) origin.
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 the CUMC Molecular Pathology Laboratory: The Columbia University
Medical Center Molecular Pathology Laboratory is a high complexity molecular
pathology laboratory that provides nucleic acid-based testing in the fields
of molecular oncology and molecular genetics, with New York state permits in
the categories of genetic testing, molecular oncology, molecular and cellular
tumor markers; and virology general, virology limited to molecular techniques
- currently performing over 30,000 tests per year in these categories. The
laboratory is a component of the Department of Pathology and Cell Biology of
Columbia University Medical Center, a national leader in diagnostics and
research on disease.
About Columbia University Medical Center
Columbia University Medical Center provides international leadership in
basic, pre-clinical and clinical research, in medical and health sciences
education, and in patient care. The medical center trains future leaders and
includes the dedicated work of many physicians, scientists, nurses, dentists,
and public health professionals at the College of Physicians & Surgeons, the
Mailman School of Public Health, the College of Dental Medicine, the School
of Nursing, the biomedical departments of the Graduate School of Arts and
Sciences, and allied research centers and institutions.
http://www.cumc.columbia.edu
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 company expects that the first microRNA diagnostic tests applying its
technology 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
expected timing of submission for approval and launch of diagnostic tests
using our microRNA technology 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 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, 2006 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 (4) Avastin(TM), a
registered trademark of Genentech, Inc.

Contact:
Media
Rachel Spielman
T: +1-212-583-2714
E: media@rosettagenomics.com

For CUMC:
Susan Craig
T: +1-212-305-9746
E: sc2756@columbia.edu

Investors
Ron Kamienchick
T: +1-646-509 1893
E: investors@rosettagenomics.com

Orin Herskowitz
T: +1-212-854-1242
E: oh2120@columbia.edu

SOURCE Rosetta Genomics Ltd

Contact: Media: Rachel Spielman, T: +1-212-583-2714, E:
media@rosettagenomics.com; For CUMC: Susan Craig, T: +1-212-305-9746, E:
sc2756@columbia.edu; Investors: Ron Kamienchick, T: +1-646-509 1893, E:
investors@rosettagenomics.com; Orin Herskowitz, T: +1-212-854-1242, E:
oh2120@columbia.edu