Rosetta Genomics Receives Conditional Approval from New York State for Lung Biomarker

Provides comprehensive profile of biomarkers in lung cancer

PRINCETON, N.J. & REHOVOT, Israel--(BUSINESS WIRE)-- Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, announces that the Company was granted conditional approval status for its ROS1 lung cancer biomarker by Fluorescence in situ Hybridization (FISH) assay from the New York State Department of Health (“NYSDOH”) under the Company’s Molecular Oncology permit. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests. With this conditional approval, Rosetta Genomics’ ROS1 by FISH assay is now available in all 50 states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information they request within 60 business days.

“Through our recent acquisition of PersonalizeDx, we have a best-in-class FISH testing program that provides informative FISH results in 98% of cases with a rapid turnaround time of 3-4 days. Combining the ROS1 lung cancer biomarker with FDA-approved ALK FISH and EGFR PCR testing provides actionable genomic targets, which enhances the oncologist’s treatment decision options,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

Rosetta Genomics offers a comprehensive test menu in lung cancer. Treating physicians have an array of options to choose from, whether they want to confirm primary lung cancer diagnosis, clarify tumor subtype, perform a full oncogenomic profile or focus exclusively on lung-specific biomarker targets via NGS, FISH, PCR and/or IHC. Rosetta Genomics will continue to pursue New York State approval for its entire menu of test offerings.

About Rosetta Genomics

Rosetta develops and commercializes a broad range of microRNA-based and other high-value molecular diagnostics. Rosetta’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 is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Through the acquisition of PersonalizeDx, the Company also offers core FISH, IHC and PCR-based testing capabilities and partnerships in oncology and urology that provide additional content and platforms that complement the Rosetta offerings. Rosetta’s cancer testing services are commercially available through the Philadelphia, PA- and Lake Forest, CA-based CAP-accredited, CLIA-certified labs. For more information visit www.rosettagenomics.com.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects including, but not limited to statements relating to Rosetta Genomics having a best-in-class FISH testing program, Rosetta Genomics’ testing turnaround times, Rosetta Genomics enhancing oncologist’s treatment options and Rosetta Genomics achieving New York State approval for any or all of its tests, 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 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, 2014 as filed with the SEC. 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20150806005394/en/

Rosetta Genomics
Ken Berlin, 609-419-9003
President & CEO
[email protected]
or
Investors:
LHA
Anne Marie Fields, 212-838-3777
[email protected]
or
Bruce Voss, 310-691-7100
[email protected]

Source: Rosetta Genomics Ltd.

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