Applied Biosystems Group

November 09, 2005 00:00 ET

Applied Biosystems Launches Global Infectious Disease Surveillance Initiative; Avian Influenza First Priority

FOSTER CITY, Calif.--(CCNMatthews - Nov 9, 2005) -

Coordinated Avian Influenza Response First Step in Containing and Responding to Potential Infectious Disease Outbreaks

Applied Biosystems (NYSE:ABI), an Applera Corporation business, today announced a comprehensive offering for responding to the avian influenza threat, that includes standardized influenza detection kits for surveillance, the availability of ongoing sequencing information of the influenza virus, and provision of access to a global influenza genome database. The purpose of these kits is to assist public health officials and researchers in evaluating and monitoring outbreaks of avian influenza. This offering is part of a broader Applied Biosystems international initiative to ensure that detection kits and up-to-date genomic data are available for priority epidemiology studies related to infectious disease threats.

As outlined in the U.S. government's National Strategy for Pandemic Influenza issued on November 1, 2005, surveillance and detection are a critical component in providing continuous situational awareness to ensure maximum protection for the public. The creation of a worldwide surveillance system capable of rapidly and reliably tracking the mutation and presence of influenza strains is a necessary first step in the fight against outbreaks.

Applied Biosystems outlined the following key components of its global infectious disease surveillance initiative:

-- Standardized Surveillance and Detection Infrastructure



-- Detailed Genetic Analysis

-- Real-Time Surveillance and Validated Influenza Detection
Kits



-- Global Influenza Information Availability

-- Applied Biosystems Infectious Disease Surveillance System

"The U.S. government and public health organizations, such as the World Health Organization, have made clear that the world must develop a robust global infectious disease surveillance infrastructure to prevent pandemics from emerging," said Mark P. Stevenson, Division President of Applied Markets for Applied Biosystems.

"Recognizing the importance of public and private partnerships to fulfill this mission, Applied Biosystems is marshalling its expertise in science, engineering, and manufacturing to meet this need, beginning with the launch of specific solutions to address the avian influenza threat," added Christopher P. Melancon, Director of BioSecurity, Applied Markets Division of Applied Biosystems.

Avian Influenza Program Details

Applied Biosystems, along with key partners in the public health community, is rolling out a comprehensive surveillance response to the avian influenza threat to help public health agencies identify H5N1 outbreaks as well as track the ongoing genetic changes of virulent influenza strains. This response includes the following components:

Standardized Surveillance and Detection Infrastructure

-- Detailed Genetic Analysis

Sequencing is an important technology for understanding genetic changes in the influenza virus. Epidemiologists can use genetic sequence information to track the evolution of the virus and the spread of the disease throughout animal and human populations.

Applied Biosystems has solicited guidance from the World Health Organization (WHO) headquarters and Collaborating Centres for Influenza to provide standardized genome sequencing protocols and technology to key public health laboratories around the world. Based on this guidance, Applied Biosystems is designing sequencing protocols and kits for distribution by March 2006, through the WHO Collaborating Centres for Influenza in Melbourne, Australia. Based on Applied Biosystems' industry-leading sequencing technology, viral genome sequencing systems are capable of sequencing and analyzing the entire influenza genome, including the dangerous H5N1 subtype. Over 12,000 of Applied Biosystems' genetic analyzers, such as the 3130 Genetic Analyzer product line and 3730 DNA Analyzer product line, are installed in more than 4,500 global locations.

-- Real-Time Surveillance and Validated Influenza Detection Kits

Genetic-based detection, based on real-time PCR technology, represents the state-of-the art in surveillance technology to determine whether the virus is present in laboratory samples.

Applied Biosystems has a global installed base of real-time PCR systems, including over 100 systems currently utilized by the U.S. national public health network, which could be called upon to contribute towards the U.S. government's national preparedness for avian influenza.

Applied Biosystems has developed a TaqMan® Influenza A/H5 Detection Kit to detect the presence of the H5 subtype, including H5N1, in human and animal samples in less than two hours. The kit, which is designed to run using standardized protocols on Applied Biosystems real-time PCR systems, is currently being tested and optimized for maximum sensitivity against viral samples of the H5N1 subtype in Hong Kong.

"The tendency of influenza viruses to undergo frequent genetic adaptation necessitates constant monitoring," said Dr. Leo L.M. Poon, Associate Professor of the Department of Microbiology at the University of Hong Kong. "By testing these avian flu virus detection kits with a broad range of historical and recently isolated samples, we can gain confidence that they will reliably detect and identify this rapidly changing virus."

"Genetic-based detection is one of the most reliable approaches for detecting the presence of harmful pathogens, including the dangerous Influenza H5N1 subtype," said Ian Barr, Ph.D., Deputy Director, World Health Organization Influenza Collaborating Centre, Melbourne, Australia. "We are pleased with the initiative that Applied Biosystems has demonstrated in supporting the global influenza scientific community to address this critical public health requirement and look forward to the roll-out of these new assays."

Further confirmation testing of the detection kits will be conducted at reference laboratory sites around the globe, including sites in Germany, Italy, Slovenia, Kenya, Thailand, Japan, and Australia. Applied Biosystems expects to ship these kits to select laboratories before the end of 2005, with broad availability in early 2006. To ensure availability of the kits in the event of an outbreak, Applied Biosystems intends to stockpile materials in the United States, United Kingdom, and Japan to enable a more rapid response to kit production and distribution.

Global Influenza Information Availability

Applied Biosystems intends to purchase non-exclusive licenses (subscriptions) for the analysis software associated with the Los Alamos National Laboratory (LANL) Influenza Sequence Database (http://www.flu.lanl.gov/). These licenses will give foreign governments and/or public health laboratories located in high risk areas of the world access to the analysis software. To ensure that there is maximal sharing of scientific information about influenza viruses between governments, scientific entities, and the private sector, laboratories using Applied Biosystems' standardized sequencing platform will be encouraged to submit influenza genome sequence information to the LANL database, GenBank®, the National Institutes of Health (NIH) sequence database, or other publicly accessible databases.

"Los Alamos National Laboratory is keenly interested in partnering with Applied Biosystems and other partners to ensure that our scientific expertise and analysis tools are available in the global efforts to combat pandemic pathogen outbreaks," said Allen Morris, Ph.D., Licensing Executive at Los Alamos National Laboratory.

Applied Biosystems Infectious Disease Surveillance System

Moving beyond the specific response to the avian influenza threat, Applied Biosystems has developed a standardized system for surveillance and detection of a broad range of infectious diseases for epidemiological use. The system includes:

-- ABI PRISM® 6100 Nucleic Acid PrepStation: Instrument module for collecting and preparing human and animal samples for testing on the real-time PCR system.

-- Applied Biosystems 7900HT Real-Time PCR System with TaqMan® Low Density Array Capability: High throughput system for identifying and characterizing specific pathogens.

-- Standardized Protocols: Pathogen-specific protocols to ensure that tests are reproducible and render reliable results.

Applied Biosystems Global Infectious Disease Surveillance Initiative

Through its global installed base of life sciences research systems, Applied Biosystems has been contributing toward public health preparedness and life science knowledge for nearly 25 years. The goal of Applied Biosystems' Global Infectious Disease Surveillance Initiative is to enable a comprehensive biosecurity infrastructure to help protect the public from emerging man-made and natural infectious disease threats, including avian influenza, anthrax, tularemia, plague, and other priority pathogens. By combining scientific expertise, genetic analysis systems and surveillance kit development with global distribution channels, Applied Biosystems intends to deliver standardized and reliable biosecurity solutions for infectious disease surveillance.

For Research Use Only. Not for Use in Diagnostic Procedures.

Applied Biosystems' influenza detection products are for research and epidemiological use only. They have not been cleared or approved by the United States Food and Drug Administration or any other regulatory agency, or under the European IVD Directive, for human diagnostic or other clinical use, and are not intended and should not be used for human diagnostic or any other clinical purposes.

About Applera Corporation and Applied Biosystems

Applera Corporation consists of two operating groups. 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. 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. Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. 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/.

Applied Biosystems Forward Looking Statement

Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "intends," "expects," "plans," 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 factors include but are not limited to (1) rapidly changing technology could adversely affect demand for Applied Biosystems' products, and its business is dependent on development and customer acceptance of new products; (2) Applied Biosystems' sales are dependent on customers' capital spending policies and government-sponsored research; (3) potential liabilities related to the use of hazardous materials, (4) risks associated with lawsuits, arbitrations, investigations, and other legal actions with private parties and governmental entities, particularly involving claims for infringement of patents and other intellectual property rights, and the possibility that Applied Biosystems may need to license intellectual property from third parties to avoid or settle such claims; (5) Applied Biosystems' dependence on the operation of computer hardware, software, and Internet applications and related technology; (6) unproven use of genomics information to develop or commercialize products; and (7) 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. ABI PRISM, Applied Biosystems and Celera are registered trademarks, Applera, 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.

TaqMan is a registered trademark of Roche Molecular Systems, Inc.

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