ViroSeq™ HIV-1 Genotyping System 510(K) Premarket Notification Submitted to FDA
Alameda, CA - July 31, 2001
Celera Diagnostics, a joint venture of Applied Biosystems Group (NYSE:ABI) and Celera Genomics Group (NYSE:CRA), Applera Corporation businesses, announced that a 510(k) Premarket Notification has been submitted to the U.S. Food and Drug Administration, seeking marketing clearance of the ViroSeq™ HIV-1 Genotyping System as an in vitro diagnostic product. This submission was filed by Applied Biosystems. Pending receipt of marketing clearance from the FDA, Applied Biosystems will have marketing responsibility for the product. The FDA has advised that the submission has been received and assigned a reference number. Celera Diagnostics and Applied Biosystems expect to work closely with the FDA to follow the accelerated “de novo” review process of the FDA Modernization Act of 1997 for the clearance of low risk class II devices which have no substantially equivalent predicate device already on the market.
The ViroSeq system is designed to detect drug resistance in the HIV-1 virus genome. “HIV-1 virus mutates rapidly, which greatly compromises the efficacy of drug regimens. We believe that genotyping with the Viroseq™ HIV-1 Genotyping System will be a useful tool in identifying drug resistance in the HIV-1 genome. With this information, physicians could in the future be able to prescribe treatment regimens that might be precisely tailored to the type of HIV-1 drug-resistant strain infecting the patient,” said Eric D. Shulse, director, molecular diagnostics of Celera Diagnostics.
Genotyping is a sequencing-based testing method used to determine the genetic composition of an organism. This technique is used by laboratories and clinicians throughout the world as a method of resistance testing for HIV. The ViroSeq system sequences the strain of HIV-1 virus infecting the patient, and is being submitted as a potential diagnostic tool that could offer clinicians information helpful in patient management. The system targets protease and reverse transcriptase genes in the HIV-1 virus that spontaneously develop drug-resistance mutations at a rapid rate.
About Applera Corporation
Applera Corporation, comprises two operating groups. 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) 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. The Celera Genomics Group, an integrated source of genomic and related medical information headquartered in Rockville, MD, is evolving to become a next generation therapeutic discovery company. Celera intends to leverage its industrialized approach to biology to develop platforms for enabling these new discoveries both for its own internal product development and for its customers, including collaboration partners and subscribers. Celera Diagnostics has been established as a joint venture between Applied Biosystems and Celera Genomics. This new venture is focused on discovery, development and commercialization of novel diagnostic tests. Information about the Company, including reports and other information filed by the Company with the Securities and Exchange Commission, is available on the worldwide web at www.applera.com or by phoning 1-800-762-6923.
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," "intend," "anticipate," "should," "planned," "estimated," and "potential," 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) ability to obtain regulatory approval; (2) market acceptance of genotyping and the Company’s products; (3) claims for patent infringement; and (4) other factors that might be described from time to time in Applera Corporation’s filings with the Securities and Exchange Commission.
The ViroSeq HIV-1 Genotyping System is not intended for use in diagnostic procedures.
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