FOSTER CITY, CA, March 11, 1999 – PE Biosystems has announced the availability of a complete, automated system for standardized, sequence-based genotyping of resistance mutations in HIV. The HIV Genotyping System is expected to be of immediate use in investigational clinical trials to monitor the development of drug-resistant HIV strains and assess the effectiveness of anti-HIV drugs. In the future, PE Biosystems plans to seek FDA approval for this system to be used as a diagnostic tool, providing important information to physicians designing individually tailored drug regimens for HIV patients.

The HIV Genotyping System incorporates the latest in PCR and automated DNA sequencing technologies. It offers optimized reagents, superior enzymes, and fully integrated knowledge-based software, all specifically designed for use on existing general purpose PE Biosystems’ PCR platforms and automated genetic analysis instruments. The system affords accuracy, sensitivity, ease-of-use, and speed of analysis in a standardized format for sequence-based HIV genotyping.

Using this system, the laboratory can begin by sampling plasma and proceed through reading a software-generated printout of variant HIV genotypes present in that sample. These genotyping results can be correlated with the therapeutic effects of new investigational drug therapies by helping to monitor the development of drug-resistant strains in response to particular drug regimens being tested in clinical trials. Built-in quality-control checks and standardization allow the results to be readily compared with those from other studies.

"The standardization, consistency, and high throughput that this genotyping system provides will substantially improve our ability to analyze large numbers of samples from clinical trials," said Dr. Lisa Demeter, head of the Sequencing Working Group of the Adult AIDS Clinical Trials Group. "This will improve our understanding of how HIV resistance develops during combination therapy, and how to most effectively design treatment regimens for this disease."

The HIV Genotyping System specifically targets the sequence of HIV protease and reverse transcriptase (RT) genes. The protein products of these genes are the primary targets of the most effective antiretroviral drugs (i.e., protease and RT inhibitors), and it is these genes that typically mutate to generate drug-resistant HIV strains. The system was developed by PE Biosystems’ Molecular Diagnostics Group, which specializes in providing easy-to-use, robust assays for clinical research studies in the area of cancer, immunology, genetic and infectious diseases. These assays, which use fluorescent DNA genetic analysis technology and customized data analysis software, make genetically based testing in the laboratory more routine.

PE Corporation currently comprises two operating groups. PE Biosystems Group, with sale of $940 million during fiscal 1998, supplies instrument systems, reagents, software, and related services to the life science industry and research community. Celera Genomics Group, a newly formed business unit, intends to become the definitive source of genomic and related agricultural and medical information. PE Corporation is headquartered in Connecticut. Information about Celera Genomics is available on the World Wide Web at http://www.celera.com or by phoning (240) 453-3000.