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Celera Diagnostics Presents Data on Fragile X Assay; New Research Assay Developed to Detect Carriers of Mutations in the Gene for Fragile X, the Leading Cause of Inherited Mental Retardation.


ALAMEDA, Calif. -- Celera Diagnostics, a joint venture between the Applied Biosystems Group (NYSE NYSE

See: New York Stock Exchange
:ABI Abi (ā`bī) [short for Abijah], in the Bible, King Hezekiah's mother.


(Application Binary Interface) A specification for a specific hardware platform combined with the operating system.
) and Celera Genomics Group (NYSE:CRA See Community Reinvestment Act. ) of Applera Corporation, today announced that it will present data on its fragile X research assay at the Association for Molecular Pathology's 11th Annual Meeting, from November 11-13, 2005, in Scottsdale, Arizona. This study shows results for amplification of normal and pre-mutation triplet triplet /trip·let/ (trip´let)
1. one of three offspring produced at one birth.

2. a combination of three objects or entities acting together, as three lenses or three nucleotides.

3.
 repeats in the FMR FMR Former (government official title)
FMR Fair Market Rents (HUD)
FMR Financial Management Regulation
FMR Friends of the Mississippi River (watershed conservancy) 
1 (fragile X mental retardation mental retardation, below average level of intellectual functioning, usually defined by an IQ of below 70 to 75, combined with limitations in the skills necessary for daily living. ) gene and sizing 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.

Fragile X syndrome Fragile X Syndrome Definition

Fragile X syndrome is the most common form of inherited mental retardation. Individuals with this condition have developmental delay, variable levels of mental retardation, and behavioral and emotional difficulties.
 is the most common cause of inherited mental retardation. The causative mutation in 99% of cases is expansion in the X chromosome X chromosome
One of the two sex chromosomes (the other is Y) that determine a person's gender. Normal males have both an X and a Y chromosome, and normal females have two X chromosomes.
 of the CGG CGG Compagnie Generale de Geophysique
CGG Cytosine-Guanine-Guanine
CGG Canadian Grenadier Guards (Canadian reserve military unit)
CGG Cancer Genetics Group (Birmingham, UK) 
 (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. Males that inherit a full mutation repeat allele allele (əlēl`): see genetics.
allele

Any one of two or more alternative forms of a gene that may occur alternatively at a given site on a chromosome.
 exhibit developmental disabilities developmental disabilities (DD),
n.pl the pathologic conditions that have their origin in the embryology and growth and development of an individual. DDs usually appear clinically before 18 years of age.
.

The Celera Diagnostics fragile X research assay is a PCR PCR polymerase chain reaction.

PCR
abbr.
polymerase chain reaction


Polymerase chain reaction (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. This research assay was developed as part of Celera Diagnostics' alliance with Abbott Laboratories, and is currently being evaluated externally.

"This research assay is a more efficient PCR method for detecting fragile X carriers compared to current procedures, and is a major advancement in the field," said Michael Zoccoli, Ph.D., Vice President of Development, Celera Diagnostics. "The data demonstrate the potential of this approach for population screening for fragile X similar to screening practices for Cystic Fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. ."

About Fragile X

Affected people with fragile X syndrome have a mutation in the FMR1 gene in the DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 that makes up the X chromosome. That mutation causes the cell to methylate methylate /meth·yl·ate/ (meth´i-lat)
1. a compound of methyl alcohol and a base.

2. to add a methyl group to a substance.


meth·yl·ate
v.
1.
 a regulatory region of the FMR1 gene. The methylation methylation,
n a phase-II detoxification pathway in the liver; methyl groups combine with toxins to rid the body of various substances.

methylation
(meth´
 turns off the FMR1 gene. Since the gene is turned off, the person doesn't make FMRP FMRP Familial Mental Retardation Protein  (fragile X mental retardation protein). That lack of this specific protein triggers fragile X syndrome.

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 2,500 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 Diagnostics and Applera Corporation

Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. The Applied Biosystems Group (NYSE:ABI) 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 RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
), 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. The Celera Genomics Group (NYSE:CRA) is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. 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 Applied Biosystems is available at http://www.appliedbiosystems.com/.

Forward-Looking Statements

Certain statements in this press release, including the Outlook sections, are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "intend," "anticipate," "should," "planned," and "potential," among others. These forward-looking statements are based on Applera Corporation's current expectations. 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 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. The risks and uncertainties that may affect the operations, performance, development, and results of Celera Diagnostics' businesses include but are not limited to: (1) Celera Diagnostics' unproven ability to discover, develop, or commercialize proprietary diagnostic products; (2) the uncertainty that Celera Diagnostics' 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 Diagnostics, its strategic alliance with Abbott Laboratories, which may not be successful; (4) Celera Diagnostics' reliance on access to biological materials and related clinical and other information, which may be in limited supply or access to which may be limited; (5) intense competition in the industries in which Celera Diagnostics operate; (6) potential product liability or other claims against Celera Diagnostics as a result of the testing or use of their products; (7) potential liabilities related to the use of hazardous materials; (8) uncertainty of the availability to Celera Diagnostics 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; (9) legal, ethical, and social issues which could affect demand for Celera Diagnostics' products; and (10) 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) 2005. Applera Corporation. All rights reserved. Applied Biosystems is a registered trademark and Applera, Celera, Celera Diagnostics, Celera Discovery System, 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.
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