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Submission for Approval:Test to Differentiate Squamous/NSCLC


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http://www.cumc.columbia.edu/news/press ... omics.html

Excerpt from press release:

. . . . . . . . .

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 Accurate diagnosis is important for guiding treatment.

Bevacizumab(1) therapy for non-squamous NSCLC, includes a warning about potential higher rates of severe or fatal hemorrhage in patients with squamous NSCLC histology.

Once approved by the New York State Department of Health, the test will be available nationwide through Columbia University Medical Center’s Molecular Pathology Laboratory, which developed and validated the test.

Rehovot, Israel; Jersey City, New Jersey, New York (April 3, 2008) – 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 (1), 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™, 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.

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(CUMC, Columbia University Medical Center, Press Release, April 8, 2008 [Contians Forward-looking Statements])

Disclaimer:

The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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