The Study Will Compare the Results of Rosetta Genomics' microRNA-based Test, miRview(TM) Squamous, Which Differentiates Squamous From non Squamous
non Small Cell Lung Cancer, With Current Diagnostic Methods A Test Based on the miRview(TM) Technology First Approved for Clinical use Through Columbia University's High Complexity Molecular Pathology Lab
Earlier This Year Rosetta Genomics is Expecting to Launch miRview(TM) Squamous Later This
Year Through its Recently Acquired CLIA lab in Philadelphia
REHOVOT, Israel and JERSEY CITY, New Jersey, October 2 /PRNewswire-FirstCall/ -- Rosetta Genomics, Ltd. (NASDQ: ROSG), a leader in the development of microRNA-based diagnostic and therapeutic products, announced today the initiation of a clinical assessment study with the Johns Hopkins University School of Medicine. The study will compare Rosetta Genomics' miRview(TM) squamous, which differentiates squamous from non squamous non small cell lung cancer, with available immunohistochemistry methods.
"We are excited to be collaborating once more with the excellent scientists at Johns Hopkins University," said Dr. Dalia Cohen. "Having this microRNA-based test assessed for clinical validity by faculty at one of the country's top cancer research centers is viewed by us as a strong indication to the interest this product and our technology are generating in the oncology world."
Differentiating squamous from non squamous cell lung cancer presents a challenge to physicians, but until recently this differentiation was not particularly relevant from a therapeutic or prognostic standpoint since no drug was designed for a specific NSCLC sub-type.
A recently approved angiogenesis inhibitor for NSCLC has been shown to have severe side effects for squamous-cell lung cancer patients. Furthermore, this targeted therapy includes a black-box warning about substantially higher rates of severe or fatal hemorrhage among NSCLC patients with predominantly squamous histology. This has led patients with squamous-cell histology to be regarded by many as inappropriate candidates for therapy with this drug. In addition, several other targeted drugs for NSCLC currently under development may require this type of accurate differentiation due to different side effect profiles or different levels of efficacy.
Combining Rosetta Genomics' proprietary microRNA extraction technology from FFPE samples, sensitive quantification platforms, and microRNA molecular biomarkers identified by the company, Rosetta Genomics has developed a test which differentiates squamous cell carcinoma of the lung from non-squamous NSCLC. This test, which is the subject of the study to be conducted at John Hopkins, is in the final stages of development and is expected to be commercially available by the fourth quarter of 2008.
In July, Columbia University Medical Center's (CUMC) High Complexity Molecular Pathology Laboratory received the approval of the New York State regulators for a test differentiating Squamous NSCLC from other NSCLC. This test, which is based on Rosetta Genomics' technology, exhibited sensitivity of 96 percent and specificity of 90 percent.
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 Johns Hopkins University
Founded in 1876, the Johns Hopkins University was the first research university in the United States. The university's emphasis on both learning and research-and on how each complements the other-revolutionized U.S. higher education. Today, Johns Hopkins has ventured from its home in Baltimore to countries throughout the world-China, Italy and Singapore, among many others. It remains a world leader in teaching, patient care and discovery.
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, Rosetta's
ability to successfully develop a test differentiating Squamous NSCLC from
other NSCLC and the expected timing of commercial launch of tests using
Rosetta's 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 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.
Joshua Gordon, M.D.,
|SOURCE Rosetta Genomics Ltd|
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