Rosetta Genomics Now Processing Fine-Needle Aspirate Cell Block Samples for Lung Cancer Subclassification Molecular test that helps determine treatment can now be performed before the tumor is surgically resected
REHOVOT, Israel & PHILADELPHIA, Apr 05, 2010 Uses highly accurate microRNA-based technology of miRview(TM) squamous test on Fine-Needle Aspirate (FNA) cell block samples to subclassify non-small cell lung cancer (NSCLC) into squamous or non-squamous
–Subclassification of NSCLC using preoperative FNA samples currently presents a challenge to physicians, with an estimated 30%-40% of cases remaining unclassified or being misclassified
–In a recent study,(1 )Johns Hopkins University researchers demonstrated that miRview squamous correctly subclassified 95% of FNA cell block specimens and small biopsies originally diagnosed as poorly differentiated NSCLC
Rosetta Genomics, Ltd. /quotes/comstock/15*!rosg/quotes/nls/rosg (ROSG 2.22, -0.06, -2.63%) , a leading developer and provider of microRNA-based molecular diagnostics, announced today that starting April 1, 2010 physicians are able to send FNA cell block samples to Rosetta Genomics’ CLIA-certified and CAP-accredited laboratory in Philadelphia for analysis using Rosetta’s miRview squamous test. FNA is a less invasive method to obtain tumor cells compared with tumor resections or biopsies. This breakthrough will enable patients and physicians to benefit from a highly accurate diagnostic assay without having to undergo a more invasive procedure.
miRview squamous is a molecular diagnostic test that measures the expression level of a single microRNA to accurately differentiate squamous from non-squamous NSCLC. The test offers patients and physicians a highly accurate diagnostic tool that produces standardized and reproducible results.
“Enabling physicians to subclassify NSCLC tumors with miRview squamous based on FNA cell blocks, without the need for more invasive procedures, brings significant value to lung cancer patient management,” noted Dr. Tina Edmonston, Director of Rosetta Genomics’ CLIA-certified laboratory. “As pathologists, we are often faced with challenges especially when trying to subclassify poorly differentiated NSCLCs. However, correct subclassification is crucial to determine the treatment of the patient. We believe this new capability will help physicians better address this issue.”
Lung cancer is the leading cause of cancer mortality in the U.S., killing more than 160,000 Americans annually. In over 60,000 of these patients with NSCLC, identification of the squamous sub-type has significant clinical implications. Squamous lung cancer carries increased risk of severe or fatal bleeding for certain targeted biological therapies, including bevacizumab (Avastin(TM)) and other drugs under development.(2) Other approved therapies, such as pemetrexed (Alimta(TM)) are indicated for non-squamous NSCLC only.(3)
“This improvement is an excellent example of how by adapting our proprietary miRNA-based technologies to be used on FNA cell block specimens, our highly accurate miRview squamous assay can be made available to more patients suffering from lung cancer,” stated Ken Berlin, President and CEO of Rosetta Genomics.
In a recently published study in Clinical Cancer Research, Johns Hopkins University researchers demonstrated that miRview squamous correctly subclassified 95% of FNA cell block specimens and small biopsies originally diagnosed as poorly differentiated NSCLC into squamous and non-squamous cell carcinoma.
About microRNAs
MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. MicroRNAs’ unique advantage as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle aspirate (FNA) cell blocks. It has been suggested that their small size (19-21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit www.rosettagenomics.com.
About miRview(TM) Products
miRview(TM) are a series of microRNA-based diagnostic tests developed by Rosetta Genomics. miRview(TM) mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary. miRview(TM) squamous accurately identifies the squamous subtype of NSCLC, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain targeted therapies. miRview(TM) meso distinguishes mesothelioma, a cancer connected to asbestos exposure, from other malignancies in the lung and pleura. miRview(TM) tests are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, over 100,000 patients a year may benefit from the miRview(TM) mets test, 60,000 from miRview(TM) squamous, and 60,000 from miRview(TM) meso, with similar numbers of patients outside the U.S. The company’s tests are now being offered through distributors around the globe. For more information, please visit www.mirviewdx.com.
About Rosetta Genomics
Rosetta Genomics is a leading developer of microRNA-based molecular diagnostics. 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 patent 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 tools. The company’s first three microRNA-based tests, miRview(TM) squamous, miRview(TM) mets and miRview(TM) meso, are performed at the company’s Philadelphia-based, CLIA-certified and CAP accredited lab. Rosetta Genomics is the 2008 winner of the Wall Street Journal’s Technology Innovation Awards in the medical/biotech category. To learn more, please visit www.rosettagenomics.com.
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, and the potential of microRNAs in the diagnosis and treatment of disease, 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 may never lead to commercially accepted 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 products and services; 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, 2009 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) Justin A. Bishop, Hila Benjamin, Hila Cholakh, Ayelet Chajut, Douglas P. Clark, William Westra. Accurate classification of non-small cell lung carcinoma using a novel microRNA-based approach. Clinical Cancer Research, 2010, 16(2) 610-619.
(2) Johnson et al, Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22:2184-91, 2004
(3) Alimta website at www.alimta.com
SOURCE: Rosetta Genomics, Ltd.
