FDA Grants Clearance For Celera Diagnostics ViroSeq HIV-1 Genotyping System
Alameda, CA - December 11, 2002
Celera Diagnostics, a joint venture between Applied Biosystems Group (NYSE:ABI) and Celera Genomics Group (NYSE:CRA), Applera Corporation businesses, today announced that it has received marketing clearance from the U.S. Food and Drug Administration for its 510(k) submission of the ViroSeq™ HIV-1 Genotyping System as an in vitro diagnostic product. The system will be manufactured by Celera Diagnostics and distributed by Abbott Diagnostics.
The ViroSeq™ system is designed to detect mutations in the HIV-1 viral genome that confer drug resistance. The system is used as an aid in monitoring and treating HIV infections.
“We believe the ViroSeq™ HIV-1 Genotyping System can be a valuable tool for physicians seeking the best course of treatment for HIV infected individuals,” said Kathy Ordoñez, President of Celera Diagnostics. “While HIV genotyping has become routine practice in the selection of drug therapy regimens to fight this disease, testing methods have yet to become standardized. The ViroSeq™ system, with its combination of FDA cleared algorithms and reagents, has the potential to become a standard among clinical testing laboratories.”
The efficacy of HIV drug therapy is challenged by the rapid mutation of the HIV-1 virus, which can lead to drug resistance and potential consequent therapeutic failure among individuals. A recent study found that 78 percent of patients showed signs of resistance to one or more drugs typically used to treat HIV. The rate of drug resistance among new cases is also increasing. Up to 20 percent of the individuals newly diagnosed with HIV were infected with a strain that was already resistant to at least one antiretroviral drug.
“Selecting a therapy that is most likely to benefit each patient is increasingly important,” said John J. Sninsky, Ph.D., Vice President of Discovery Research of Celera Diagnostics. “Each year, more than 150,000 HIV genotyping tests are conducted, and over 40,000 new cases of HIV infections are diagnosed in the U.S. alone. In many of these new cases, the infection is already resistant to one or more antiretroviral drugs. The ViroSeq™ system can provide important new information to physicians and patients for effective therapy selection.”
The ViroSeq™ system consists of an Applied Biosystems automated DNA sequencing platform and reagents used to identify the different strains of the HIV-1 virus that infect the patient. The system targets specific regions of the viral genome that can spontaneously develop drug-resistant mutations. Genotyping is a sequencing-based testing method that is routinely used by laboratories and clinicians throughout the world to determine the genetic composition of the HIV virus. Applied Biosystems sequencing instruments are currently used for the majority of HIV genotype testing performed in the United States.
Celera Diagnostics plans to extend application of the ViroSeq™ system for use on an expanded range of ABI sequencing platforms, facilitating standardization of resistance testing in low, mid, and high-throughput reference laboratories. It also plans to periodically revise its software to include information on newly launched drugs.
The ViroSeq™ HIV-1 Genotyping System was previously approved for sale and commercial use in France and Argentina.
About Celera Diagnostics and Applera Corporation
Celera Diagnostics is a 50/50 joint venture between two Applera Corporation businesses, Applied Biosystems and Celera Genomics. Headquartered in Alameda, CA, Celera Diagnostics focuses on discovering novel genetic markers for disease and configuring these into new diagnostic tests to predict, characterize, monitor and select therapy for cardiovascular disease, auto-immunity, central nervous system disorders, and cancer. The Applied Biosystems Group develops and markets instrument-based systems, reagents, software, and contract services to the life science industry and research community. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries, leading to the development of new pharmaceuticals, and to conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.6 billion during fiscal 2002. The Celera Genomics Group, 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 diagnostic marker candidates, and to discover and develop new therapeutics. Its Celera Discovery System™ online platform, marketed exclusively through the Applied Biosystems Knowledge Business, is an integrated source of information based on the human genome and other biological and medical sources. 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.
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,” “plan,” 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 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) unproven ability of Celera Diagnostics to discover, develop, and commercialize diagnostic products; (2) uncertainty in obtaining intellectual property protection for inventions made by Celera Diagnostics, and uncertainty in obtaining any necessary third party intellectual property licenses; (3) uncertainty that laboratories will adopt the ViroSeq™ HIV Genotyping System; (4) unproven ability to scale up manufacturing as products sales increase; (5) the risk that certain raw materials and equipment required may not be available or may not be available at acceptable prices; (6) potential product liability or other claims against Celera Diagnostics as a result of the testing or use of its products; and (7) other factors that might be described from time to time in Applera’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.
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