ROSETTA GENOMICS LTD. (USA) Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based molecular diagnostics and therapeutics, announces the commercial launch of the first of the oncology testing services gained through its previously announced collaboration with Admera Health (October 30, 2014). Rosetta Genomics is now offering PGxOne™, a pharmacogenomics test that predicts patients’ responses to drugs based on their personal genetic makeup to avoid adverse effects; and EGFR and KRAS clinical sequencing, which provides genomic analysis of those tumor-based mutations from patient tissue to provide clinically relevant information relating to potential response to therapy, which is helpful for physicians, pathologists and researchers.
EGFR and KRAS sequence analysis of tumor biopsies can help predict tumor response to specific targeted therapies. These biomarkers are most often used to help determine treatment of non-small cell lung and colorectal cancers, and are predictive and prognostic indicators for patients on tyrosine kinase inhibitor drugs, such as Erlotinib (Tarceva®) and Gefitinib (Iressa™), and anti-EGFR monoclonal antibody drugs, such as panitumumab (Vectibix®) and cetuximab (Erbitux®).
Genomic differences between individuals can affect drug absorption, metabolism, or activity, thus one treatment regimen may work well for one patient while potentially causing adverse effects for other patients. Cancer patients may require other medications beyond their cancer therapy that may interact in a drug-gene-drug fashion and complicate their care. PGxOne™ provides medically actionable and clinically relevant data for cancer patients, helping physicians to make better treatment decisions in advance.
Rosetta Genomics’ 12-person specialty molecular diagnostics sales force will be promoting PGxOne, EGFR and KRAS to oncologists and pathologists, the same call points for Rosetta’s current molecular diagnostic tests. Importantly, the PGxOne™ product offering provides the opportunity to expand Rosetta Genomics’ sales call point to hospital-based pharmacies. In addition to traditional sales and marketing efforts, Rosetta Genomics and Admera Health are in the process of creating a webinar series aimed at educating pathologists and oncologists about the benefits of their molecular and genomic testing services as a tool to help inform treatment decisions and to potentially improve patient outcomes.
“In addition to building our revenue base, these product launches allow us to leverage our commercial infrastructure and provide our sales representatives with a more complete diagnostic solution for pathologists and oncologists, while accelerating the delivery of sequencing-based genomic tests that offer greater personalized testing options for patients,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “There are inherent synergies with these new products and our existing suite of cancer testing services. Combining Rosetta’s Cancer Origin Test information on tumor type with Admera’s powerful genomic tests provides physicians with clinically relevant and medically actionable information from which to help define their treatment protocols, as opposed to using blind sequencing in the setting of anatomic uncertainty. In cases of known primary cancers, our combined offerings will provide a broader array of testing options to obtain genomic information of value as defined in the guidelines of a variety of cancers, specifically with lung or colon cancer. Consequently, we expect this expanded offering will be well received by pathologists and oncologists.”
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately identify the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). Rosetta Mesothelioma Test™ diagnoses mesothelioma, a cancer connected to asbestos exposure. The Rosetta Lung Cancer Test™ accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. Rosetta’s assays 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, Rosetta Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test™, 60,000 from the Rosetta Mesothelioma Test™, 65,000 from the Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The Company’s assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visit www.rosettagenomics.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Admera Health
Admera Health is an advanced molecular diagnostics company focused on personalized medicine and non-invasive cancer testing. Utilizing NGS technologies and bioinformatics analysis, Admera Health delivers cost-effective clinical diagnostics spanning the continuum of care from its established, CLIA-certified, CAP-accredited laboratory. Admera Health seeks to redefine disease screening, diagnosis, treatment, monitoring, and management through its innovative, personalized solutions. Admera Health is a GENEWIZ company. For more information, please visit www.admerahealth.com.
About Rosetta Genomics
Founded in 2000, 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 and therapeutics. Rosetta currently commercializes a full range of microRNA-based molecular diagnostics. Rosetta’s cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. For more information, 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 Rosetta's collaboration with Admera Health, Rosetta's marketing of the PGxOne™, EGFR and KRAS tests and Rosetta expanding its sales call point to hospital-based pharmacies, 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, 2013 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.
