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Posted: April 5, 2010
Rosetta Genomics Now Processing Fine-Needle Aspirate Cell Block Samples for Lung Cancer Subclassification
(Nanowerk News) Rosetta Genomics, Ltd., 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™) and other drugs under development.2 Other approved therapies, such as pemetrexed (Alimta™) 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.
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.
About miRview™ Products
miRview™ are a series of microRNA-based diagnostic tests developed by Rosetta Genomics. miRview™ mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary. miRview™ 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™ meso distinguishes mesothelioma, a cancer connected to asbestos exposure, from other malignancies in the lung and pleura. miRview™ 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™ mets test, 60,000 from miRview™ squamous, and 60,000 from miRview™ 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™ squamous, miRview™ mets and miRview™ 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.