Applied Biosystems Introduces The VariantSEQr™ Resequencing System For Fully Integrated And Cost Effective Dna Sequence Variation Studies

FOSTER CITY, CA – February 12, 2004 – Applied Biosystems (NYSE:ABI), an Applera Corporation business, today announced the commercial availability of the VariantSEQr™ Resequencing System, the first complete, cost-effective solution for the discovery of DNA variants. The VariantSEQr™ System, which runs on Applied Biosystems’ industry leading DNA analyzers, enables researchers to conduct genetic sequence variation studies to better understand the causes and prevention of disease, facilitate the development of better and more targeted therapies and diagnostics, and understand individual response to treatment.

Resequencing, also known as mutational profiling, is a method by which the sequence information of one or multiple DNA samples is compared to a known reference sequence to determine whether any genetic variations are present. The VariantSEQr™ System is a fully automated solution that includes high confidence, ready-to-use primers for high throughput amplification and resequencing of thousands of genes in the human genome. Additionally, Applied Biosystems expects to release resequencing sets for non-human and non-gene targets, such as pathogens and human-mouse conserved regions, that are of high commercial and scientific value.

“Previously, resequencing projects have largely been limited to scientists with expertise in areas such as primer design, polymerase chain reaction (PCR) optimization, and data analysis, and were often viewed as too difficult and too expensive,” said Michael W. Hunkapiller, Ph.D., President of Applied Biosystems. “The VariantSEQr™ Resequencing System should make resequencing much easier and more affordable because no primer design or validation is required by the user. Furthermore, the high-quality, expert designed primers should ultimately provide a more accurate picture of human genetic variation.”

 “Validated resequencing sets associated with, for example, molecular function or biological process, together with integrated instrumentation, reagents, and software should enable better coverage across candidate genes with less time and cost, and create a more complete genetic picture for disease research,” said Catherine M. Burzik, Executive Vice President of Applied Biosystems. “Additionally, the large numbers of institutions already using our DNA analyzers can easily incorporate the VariantSEQr™ System into their laboratories, and add mutation detection to the growing list of integrated science applications that Applied Biosystems supports through our iScience™ business strategy.” 
 
The system is available for use on either the Applied Biosystems 3730xl and 3730 DNA Analyzers or the ABI PRISM® 3100 and 3100-Avant Genetic Analyzers, and also employs the Applied Biosystems GeneAmp® PCR System 9700, PCR master mix and BigDye™ Terminator v3.1 sequencing reagents, and SeqScape® Software v2.1. Additionally, simple, robust PCR and sequencing protocols streamline the resequencing process, and the resequencing sets are ready-to-use at the correct concentrations.

Customer Test Sites
The VariantSEQr™ Resequencing System was initially evaluated at five customer sites, including the Genome Sequencing Center at Washington University School of Medicine and at the Core Genotyping Facility as part of the SNP500 Cancer Project. 

“When we began resequencing clinical samples from patients with acute myelogenous leukemia to compare mutation profiles in tumors, we quickly realized just how tedious and expensive the process was for selecting, designing and testing PCR primers,” said Elaine R. Mardis, Ph.D., Assistant Professor in Genetics, Director of Technology Development and Co-Director of the Genome Sequencing Center at Washington University School of Medicine. “The VariantSEQr™ Resequencing System has eliminated these time-consuming and costly steps, and overall has delivered significantly higher PCR pass rates the first time than we could achieve with our own primer sets.”

“In two months, with the effort of less than one staff member, our lab was able to resequence seven candidate cancer gene coding regions, comprising 152 amplicons in 102 individuals,” said Bob Welch, Deputy Director of the Core Genotyping Facility and a contractor for SAIC-Frederick, Inc. “Analysis of the data generated by this study showed 133 known SNPs (from Genbank), but more importantly identified 170 novel SNPs. Using the Applied Biosystems resequencing system, we were able to reduce project time by more than a month and the number of PCR reactions required by almost half.”
 
Resequencing Set Selection and Online Ordering
The VariantSEQr™ Resequencing System can be ordered through the myScienceSM research environment at http://myscience.appliedbiosystems.com/. myScience is a free, online life science research environment and virtual community within the Applied Biosystems Web site that focuses on the design and analysis of genomic based experiments.  Researchers can view resequencing sets for thousands of genes, select the specific ReSequencing Set identification (RSS ID), and order the resequencing sets online. Search options include key words, chromosomal or marker position within the genome, Celera, RefSeq, and GenBank identification numbers, molecular function, and biological processes. Researchers can also “suggest a gene” if their gene of interest is not currently available. Applied Biosystems expects to release additional genes of importance based on feedback from researchers. 

SNP Genotyping Portfolio from Applied Biosystems
Applied Biosystems also offers SNP Genotyping products that complement the VariantSEQr™ Resequencing System by enabling researchers to perform both large and small disease association studies to correlate identified genetic variations with their effects on human health and disease. For high throughput genotyping studies, Applied Biosystems offers the SNPlex™ Genotyping System, an ultra high throughput solution comprised of reagents and software that run on the Applied Biosystems DNA Analyzers, the same systems that are used with the VariantSEQr™ Resequencing System and for de novo sequencing. Applied Biosystems also offers the largest selection of pre-validated, off-the-shelf SNP genotyping assays through its TaqMan® Assays-on-Demand™ SNP Genotyping Products. The Assays-on-Demand™ products are real-time PCR, TaqMan® probe-based assays that run on the ABI PRISM® 7900HT Sequence Detection System. These single tube assays are designed for focused association studies looking at a smaller number of SNPs over many biological samples. Together these products form a comprehensive solution for the discovery, characterization, and validation of DNA variations that affect human health.

American Association for the Advancement of Science
The VariantSEQr™ Resequencing System is being debuted at the American Association for the Advancement of Science (AAAS) Annual Meeting in Seattle, WA, February 12-16, 2004. AAAS is the world’s largest general scientific society, and its annual meeting attracts a diverse audience from all scientific disciplines and from the industrial, academic, nonprofit and policy communities.

Integrated Science – iScience™
To better understand the complex interaction of biological systems, life scientists are developing revolutionary approaches to discovery that unite technology, informatics, and traditional laboratory research.  In partnership with our customers, Applied Biosystems provides the innovative products, services and knowledge resources to make this new, integrated science possible. For more information about Integrated Science, please visit http://www.appliedbiosystems.com.

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, develop new pharmaceuticals, and conduct standardized testing.  Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.7 billion during fiscal 2003. The Celera Genomics Group (NYSE:CRA), located in Rockville, MD, and South San Francisco, CA, is engaged principally in integrating advanced technologies to discover and develop new therapeutics. Celera intends to leverage its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop new therapeutics. Its Celera Discovery SystemTM online platform, marketed exclusively by Applied Biosystems, is an integrated source of information based on the human genome and other biological and medical sources. Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of novel 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/.

Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such “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 and dependence on development of new products; (2) unproven use of genomics information to develop or commercialize products; (4) sales dependent on customers’ capital spending policies and government-sponsored research; (5) the dependence on the operation of computer hardware, software, and Internet applications and related technology; (6) and 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© 2004. Applera Corporation. All rights reserved. For research use only. Not for use in diagnostic procedures. Applied Biosystems and ABI PRISM are registered trademarks and Applera, Assays-on-Demand, Celera, Celera Diagnostics, Celera Discovery System, Celera Genomics, iScience, myScience, and VariantSEQr 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.

Practice of the patented polymerase chain reaction (PCR) process requires a license. The ABI PRISM® 7900HT Sequence Detection System and the Applied Biosystems 7300/7500 Real-Time PCR Systems are Authorized Thermal Cyclers for PCR and may be used with PCR licenses available from Applied Biosystems. Their use with Authorized Reagents also provides a limited PCR license in accordance with the label rights accompanying such reagents.  Purchase of this instrument does not convey any right to practice the 5′ nuclease assay or any of the other real-time methods covered by patents owned by Roche or Applied Biosystems.