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).
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
T: +1-646- 509 1893
|SOURCE Rosetta Genomics Ltd|
Copyright©2008 PR Newswire.
All rights reserved