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Fw: NATAP: New Real-Time HCV Genotype Test

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  • Alley Pat
    NATAP http://natap.org/ ... New Real-Time HCV Genotype Test Celera Receives Approval to CE Mark a New Real Time PCR HCV Genotyping Test --Highly Accurate Test
    Message 1 of 1 , Jul 26, 2006
      NATAP http://natap.org/
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      New Real-Time HCV Genotype Test

      Celera Receives Approval to CE Mark a New Real Time PCR HCV Genotyping Test
      --Highly Accurate Test Detects Major Genotypes of Hepatitis C, Further Reducing the Risk of "Mistyping" Errors

      ROCKVILLE, MD - July 25, 2006

      Celera Genomics (NYSE:CRA), an Applera Corporation business, today announced that a highly accurate and sensitive new test used for genotyping of the hepatitis C virus (HCV) has received approval to CE Mark the RealTimeâ"¢ HCV Genotype Assay, which allows it to be marketed in the European Union as a diagnostic product. This is the first real-time test for genotyping the HCV virus to obtain regulatory approval for commercial sale in Europe, and is designed for use on the automated ABI PRISM® 7000 real-time PCR (polymerase chain reaction) system from Applied Biosystems. The test was developed, and will be sold, through Celera's alliance with Abbott.

      "The hepatitis C virus has significant genetic variability throughout its entire genome", said Kathy Ordonez, President of Celera. "The accurate identification of the HCV genotypes is an important factor in the management of HCV-infected individuals, and this new RealTime HCV Genotype test gives European laboratories an important new option for delivering highly reliable test results to patients quickly and efficiently."

      Real-time PCR enables the production of large quantities of DNA from clinical samples in a short period of time, making it possible to detect low levels of a virus's genetic material. The new Abbott RealTimeâ"¢ HCV Genotype test automates key steps of the process, from PCR to data analysis and generation of a results report, allowing laboratories to process molecular tests efficiently and accurately.

      The new CE Mark approval expands the menu of tests available to European laboratories working in HCV infection, complementing the HCV quantitative viral load test currently available for use on the Abbott m2000â"¢ system. A version of the HCV genotyping test adapted to the m2000 system is under development at Abbott.

      About the RealTime HCV Genotyping Test
      The HCV genotype is determined by means of a target specific amplification using reverse transcription-polymerase chain reaction (RT-PCR) to generate amplified product from the specific HCV RNA sequences. The new RealTime HCV genotyping test delivers 32 results in less than 6 hours with a limit detection of 1,244 IU/ml, making it more sensitive than any other comparable commercially-available test. This is the first RT-PCR genotyping assay approved for use with the advantages of enhanced turn-around time while minimizing sample preparation and optimizing ease of use in any size laboratory .

      About Applera Corporation and Celera Genomics
      Applera Corporation consists of two operating groups. The Celera Genomics Group uses proprietary genomics and proteomics discovery platforms to develop molecular diagnostic products and to identify and validate novel drug targets. Celera maintains a strategic alliance in molecular diagnostics with Abbott. In addition, Celera is developing new molecular diagnostic and pharmacogenomic assays outside of its alliance with Abbott. Therapeutic antibodies against Celera-discovered drug targets are being advanced through strategic partnerships. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries and develop new pharmaceuticals. Applied Biosystems' products also serve the needs of some markets outside of life science research, which we refer to as â?oapplied markets,â? such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. Applied Biosystems is headquartered in Foster City, CA, and reported sales of nearly $1.8 billion during fiscal 2005. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800.762.6923. Information about Celera Genomics is available at http://www.celera.com.

      Forward-Looking Statements
      Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "should," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to (1) uncertainty that the RealTimeâ"¢ HCV Genotype assay will be accepted by the market, including the risk that this product will not be competitive with products offered by other companies; and (2) other factors that might be described from time to time in Applera's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

      Copyright© 2006. Applera Corporation. All rights reserved. Celera is a registered trademark and Applera, Applied Biosystems and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries. m2000 and RealTime are trademarks of Abbott Laboratories.



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