Development and validation process of Rosetta Genomics' miRview mets published

Mar 30 2010

Rosetta Genomics, Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces publication of an article describing the development and validation process of miRview™ mets, the company's microRNA-based test for identification of primary origin of metastases. The article, "Validation of a microRNA-based qRT-PCR test for accurate identification of tumor tissue origin," was published on March 26^th in the online issue of Modern Pathology, a peer-reviewed publication. The abstract of the study may be viewed online at: http://www.nature.com/modpathol/journal/vaop/ncurrent/abs/modpathol201057a.html

“This publication is yet another validation of the significant advantage of microRNAs as biomarkers”

It is estimated that more than 70,000 patients in the U.S. are diagnosed with CUP, and thousands more have metastases where the origin is difficult to identify. Knowing the origin of a metastasis affects treatment decisions, and CUP patients may undergo a wide range of costly, time-consuming and inefficient tests to identify the primary site of origin, often to no avail.

The miRview™ mets test, which included more than 850 samples in its development and validation, uses two classifiers that independently look for a primary origin. When the two classifiers reach the same answer, the test reports a single predicted origin. When the two classifiers identify two different predicted origins, both are reported. In the study described in Modern Pathology, the overall sensitivity was approximately 85%, and the sensitivity of a single answer prediction was approximately 90%. Overall specificity was 97%-99%.

"This publication is yet another validation of the significant advantage of microRNAs as biomarkers," said Kenneth A. Berlin, President and CEO of Rosetta Genomics. "Their high tissue specificity, stability in a wide range of sample types and the large amount of biological information they carry makes microRNAs ideal biomarkers for a range of disease states and indications, including metastatic cancer. As we have previously announced, we expect to launch a second generation of our miRview™ mets in the second half of 2010. This new version is expected to be able to identify approximately twice the number of origins compared with the first generation test."

miRview™ mets leverages Rosetta Genomics' proprietary microRNA technologies to assign a primary site to metastases in cases where the physician is unsure of its origin. These technologies were described in-depth in a study by Rosetta Genomics, published March 2008 in Nature Biotechnology.

miRview™ mets is marketed in the U.S. by Prometheus Laboratories under the ProOnc™ mets brand, and is available outside the U.S. through various distributors under the miRview™ mets brand.