FDA Licenses the Rosetta Resolver(R) System for Use in the Center for Drug Evaluation and Research.SEATTLE -- Rosetta Biosoftware (NYSE NYSE See: New York Stock Exchange :MRK MRK Merck & Company (stock symbol) MRK Mayer-Rokitansky-Kuster (anomaly) MRK Manual Remote Keying ) today announced that the U.S. Food and Drug Administration's Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. (CDER CDER Center for Drug Evaluation and Research (US FDA) CDER Centre de Développement des Energies Renouvelables (French) CDER Client Development and Evaluation Report ) will evaluate the Rosetta Resolver system for gene expression data management and analysis. CDER will use the Rosetta Resolver system in the Voluntary Genomics Data Submissions (VGDS VGDS Visual Guidance Docking System ) program to analyze microarray data from sponsors. The VGDS program provides a means for sponsors to ensure that regulatory scientists are familiar with and are prepared to appropriately evaluate future genomics submissions. CDER will use the Rosetta Resolver system to better understand, learn from and reproduce analyses conducted by pharmaceutical companies who voluntarily submit genomics data. In addition, they will perform independent analyses using the Rosetta Resolver system's microarray data management and analysis tools. "As the VGDS program gains momentum, CDER will receive a wide variety and growing volume of gene expression data," said Yelena Shevelenko, vice president and general manager of Rosetta Biosoftware. "The Rosetta Resolver system's robust capacity, ability to analyze and manage varying data formats, and support of industry standards allows it to efficiently accept and manage these data. In addition, Rosetta Biosoftware is committed to work with sponsors and the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to simplify and standardize the submission process." The Rosetta Resolver system is developed and supported by Rosetta Biosoftware, and is distributed exclusively by Agilent Technologies This article needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. , Inc. About the Rosetta Resolver System The Rosetta Resolver system is a high-capacity data storage, retrieval, and analysis solution for gene expression data. The system is ideal for life science research organizations that need to assess compound specificity or toxicity, identify new genes or therapeutic targets or compare and analyze large databases of expression profiles. The Rosetta Resolver system combines flexibility and ease of use with high-performance algorithms to produce a comprehensive solution for rapid analysis of gene expression data. The Rosetta Resolver system can accept and analyze data from a wide variety of expression profiling formats, including Agilent DNA microarrays, and applies Rosetta Biosoftware's proprietary error models to yield quality statistics for every gene expression measurement within the system. These statistics are automatically leveraged by Rosetta Resolver system analysis tools for optimal results. Life science research organizations that have licensed the Rosetta Resolver system include many of the top pharmaceutical companies in the world, such as Aventis Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline and Merck & Co., Inc., as well as premier academic institutions such as the Harvard University Center for Genomics Research. Additional information about the Rosetta Resolver system can be found on the Rosetta Biosoftware Web site at www.rosettabio.com. About Rosetta Biosoftware Rosetta Biosoftware is a leading provider of informatics solutions for life science research. Its enterprise software solutions, including the Rosetta Resolver and Rosetta Elucidator systems, empower life scientists with advanced, scalable, and easy-to-use analysis platforms that accelerate discovery research. Rosetta Biosoftware is a business unit of Rosetta Inpharmatics LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Merck & Co., Inc. (NYSE:MRK). More information about Rosetta Biosoftware is available at www.rosettabio.com. Forward-Looking Statements This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Neither Rosetta Inpharmatics nor Merck & Co., Inc. undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect the business of Merck & Co., Inc. including, among others, the extent to which Rosetta Inpharmatics' technology platform can be used in drug discovery programs, uncertainty of market acceptance of Rosetta Inpharmatics' technologies, ability to compete against existing technologies, and those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q Form 10-Q See 10-Q. and Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. (if any) which are incorporated by reference. Rosetta Resolver and Rosetta Elucidator are U.S. registered trademarks of Rosetta Inpharmatics LLC. |
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