Rosetta Biosoftware
NYSE : MRK

Rosetta Biosoftware

August 24, 2005 11:00 ET

FDA Licenses the Rosetta Resolver® System for Use in the Center for Drug Evaluation and Research

SEATTLE--(CCNMatthews - Aug 24, 2005) -

Rosetta Biosoftware (NYSE:MRK) today announced that the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) 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) 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 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, 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, a wholly owned subsidiary 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 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 for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K (if any) which are incorporated by reference.

Rosetta Resolver and Rosetta Elucidator are U.S. registered trademarks of Rosetta Inpharmatics LLC.

Contact Information

  • Rosetta Biosoftware
    Myra Ozaeta, 206-926-1288