Celera Genomics' Collaborators Present Feasibility Data on Fragile X Research Assay at ACMG Meeting in San Diego, CA.

ROCKVILLE, Md. -- New Research Assay Found to Be Precise with Minimal "Hands On" Time, and Greatly Reduces Time to Detection Compared with Existing Methodologies

Celera Genomics (NYSE:CRA), an Applera Corporation business, today announced that preliminary data from a feasibility study using its fragile X research assay evaluated by one of its collaborators from Oregon Health and Science University will be presented in a poster session at the 2006 American College of Medical Genetics annual meeting in San Diego, CA. Fragile X syndrome is the most common cause of inherited mental retardation. This feasibility study found that the research assay reduced the time to determine normal alleles to 1 day compared with the current 4-7 days using in-house developed existing methodologies, and with an agreement rate of more than 95% in clinical samples with normal and intermediate size alleles. This study demonstrates that considerable laboratory technician time could be saved by referring only non-normal outcomes for additional tests through PCR-acrylamide gels and Southern blotting.

The Celera fragile X research assay is a PCR assay that co-amplifies a novel gender-specific gene simultaneously with triplet repeats up to 645 units, and sizes repeats up to 230 units on ABI PRISM(R) 3100 and 3130 Genetic Analyzers. Previous internal studies have demonstrated results for amplification of normal and pre-mutation triplet repeats in the FMR1 (fragile X mental retardation) gene and size them on the ABI PRISM(R) 3100 and 3130 Genetic Analyzers. Also included is amplification of a novel gender gene that can be used to determine whether females have two normal copies of the repeats. This research assay is being developed as part of Celera's alliance with Abbott.

The causative mutation in 99% of cases of fragile X syndrome is expansion in the X chromosome of the CGG (cytosine-guanine-guanine) triplet repeat in the FMR1 gene, which can be categorized into four classes based on the size of the repeat: normal (5-44 repeats), intermediate-grey zone (45-54 repeats), pre-mutation (55-200 repeats), and full mutation (greater than 200 repeats). Pre-mutation repeats may expand to full mutations in the next generation. Females that have either a pre-mutation or full mutation repeat length alleles are carriers, and some females with full mutations are affected. Males that inherit a full mutation repeat allele exhibit developmental disabilities.

"The results we obtained were reproducible and agreed well with our in-house method. This assay requires minimal hands-on time, is rapid, uses existing instrumentation, and generally fits well into the workflow of our clinical laboratory," said Monique Johnson, Ph.D., Clinical Medical Genetics Fellow of the Molecular Diagnostic Center in the Department of Molecular and Medical Genetics at Oregon Health and Science University, Portland, Oregon, one of the authors on the poster. "The research assay has further potential benefits to the process of detecting fragile X syndrome. By using this assay rather than our current methodologies of PCR-acrylamide gels and Southern blotting, potentially 94% fewer autoradiographs could be performed in our laboratory, effectively minimizing the existing problematic issues associated with radioactivity such as cost, accidental spills and disposal, as well as neurotoxicity with acrylamide. Additionally, data for normal individuals would be stored electronically, minimizing the storage of membranes and autoradiographs."

"We're pleased with the findings of this evaluation study using our research assay as they reinforce our initial findings that the assay allows a more efficient PCR method for detecting fragile X carriers compared to current procedures," said Michael Zoccoli, Ph.D., Vice President of Development at Celera Genomics.

About Fragile X

Affected people with fragile X syndrome have a mutation in the FMR1 gene in the DNA that makes up the X chromosome. That mutation causes the cell to methylate a regulatory region of the FMR1 gene. The methylation turns off the FMR1 gene. Since the gene is turned off, the person doesn't make FMRP (fragile X mental retardation protein). That lack of this specific protein triggers fragile X syndrome. Those for whom molecular testing should be considered are individuals with mental retardation, developmental delay, autism, ovarian dysfunction, or late onset intention tremor and ataxia of unknown origin. Additional candidates for testing include those seeking reproductive counseling who have a family history of fragile X syndrome or undiagnosed mental retardation, as well as fetuses of carrier mothers.

Little information exists for ethnic/racial groups; however, population-based estimates in admixed, African-derived populations suggest that the prevalence of the full mutation may be 1 in 5,000 males. No study has determined the prevalence of the full mutation among females in the general population. However, based on the prevalence of the full mutation in males, 1 in 8-9,000 females in the general population may be affected by the fragile X syndrome (Crawford et al., 2001).

About Celera Genomics and Applera Corporation

Applera Corporation consists of two operating groups. The Celera Genomics Group is focused on discovery, development, and commercialization of diagnostic products as well as leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets and pharmacogenomic markers. It seeks to advance its therapeutic discoveries through partnerships with technology and market leaders. 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 "applied markets," 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," "expect," "intend," 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 Corporation 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 risks and uncertainties include but are not limited to: (1) Celera Genomics' unproven ability to discover, develop, or commercialize proprietary diagnostic products; (2) the uncertainty that Celera Genomics' products will be accepted and adopted by the market, including the risk that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (3) reliance on existing and future collaborations with other companies, including, in the case of Celera Genomics, its strategic alliance with Abbott Laboratories, which may not be successful; (4) intense competition in the industries in which Celera Genomics operate; (5) potential product liability or other claims against Celera Genomics as a result of the testing or use of their products; (6) uncertainty of the availability to Celera Genomics of intellectual property protection, limitations on their ability to protect trade secrets, the risk to them of infringement claims, and the possibility that they may need to license intellectual property from third parties to avoid or settle such claims; (7) legal, ethical, and social issues which could affect demand for Celera Genomics' products; and (8) other factors that might be described from time to time in Applera Corporation'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(C) 2006. Applera Corporation. All rights reserved. Applied Biosystems is a registered trademark and Applera, Celera, and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries.

Reference

Crawford DC, Acuna JM, Sherman, SL. (2001) FMR1 and the fragile X syndrome: Human genome epidemiology review. Genetics in Medicine. 3(5): 359-371.