Study Published by Rosetta Genomics and Collaborators in the Journal of Clinical Oncology Shows MicroRNA-based Diagnostic Identifies Squamous Lung Cancer with 96% Sensitivity
Mar 9, 2009 16:12:00 (ET)
PHILADELPHIA & REHOVOT, Israel, Mar 09, 2009 (BUSINESS WIRE) -- --Squamous type lung cancer carries increased risk of severe or fatal bleeding for certain drugs including Bevacizumab (Avastin(TM)), yet might be misclassified in as many as 30% of the cases
--Rosetta's miRview(TM) squamous, based on the same microRNA biomarker that was evaluated by this study, is the only commercially available diagnostic test that objectively identifies squamous lung cancer; may benefit over 60,000 lung cancer patients annually in the US
Rosetta Genomics Ltd. (ROSG, Trade ) and collaborators announced today the results of a research study, showing for the first time that a microRNA-based diagnostic test can objectively identify squamous lung cancer with 96% sensitivity. The study, posted today on the Journal of Clinical Oncology's Web site,[1] was carried out in collaboration with researchers at Columbia University, NYU Cancer Institute at NYU Langone Medical Center and Sheba Medical Center, and included 262 patients. Rosetta's miRview(TM) squamous test, based on the same microRNA biomarker that was evaluated by the study, offers similar accuracy (97% sensitivity) and is now commercially available through Rosetta Genomics CLIA-certified lab in Philadelphia.
"The results of this study are very encouraging," said Mahesh Mansukhani, Head of Molecular Pathology Laboratory, Columbia University Medical Center, and principal investigator of the study. "The study has demonstrated that a microRNA biomarker successfully identifies squamous lung cancer with high reproducibility, sensitivity, and specificity."
The company's scientists and collaborators have shown that a single microRNA biomarker, obtained from a routine pathological preparation (FFPE) of a biopsy, identified squamous lung carcinomas with 96% sensitivity and 90% specificity.
Lung cancer is the leading cause of cancer mortality in the US, killing over 160,000 Americans every year. In over 60,000 of these patients with non-small cell lung carcinoma (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] Yet recent studies comparing the reliability of histopathological classification found that as many as 30% of the squamous lung cancers were misclassified.[4]
"The study strongly validates the microRNA technology that underlies our miRview(TM) squamous test, one of three important cancer diagnostic products we launched last quarter," noted Amir Avniel, President and CEO of Rosetta Genomics. "We are now focused on marketing these diagnostic tests through distribution alliances, such as our recently announced agreement with Teva Pharmaceutical Industries Ltd, and other sales and marketing efforts, and expect to expand our distribution agreements in 2009."
To order the test, physicians may contact 1-888-522-7971, or visit the company's website at www.rosettagenomics.com/squamous .
[1] Lebanony et al., A diagnostic assay based on hsa-miR-205 expression distinguishes squamous from non-squamous non small-cell lung carcinoma, Journal of Clinical Oncology, March 2009
[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
[4] Field et al., Lung cancer histologic type in the surveillance, epidemiology, and end results registry versus independent review. Journal of the National Cancer Institute 96:1105-1107, July 2004
miRview(TM) is a registered trademark of Rosetta Genomics Ltd Avastin(TM) is a registered trademark of Genentech BioOncology, Inc Alimta(TM) is a registered trademark of Eli Lilly
About Rosetta Genomics
Rosetta Genomics (ROSG, Trade ) 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 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 tools. The company's first three microRNA-based tests, miRview(TM) squamous, miRview(TM) mets, and miRview(TM) meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of Wall Street Journal's Technology Innovation Awards in the medical/biotech category. |
