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FDA GRANTS INVESTIGATIONAL DEVICE EXEMPTION FOR VIROSEQ.

Applied Biosystems Group (NYSE: ABI), Foster City, Calif., an Applera Corporation business, has announced that the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research has approved an Investigational Device Exemption (IDE) for the ViroSeq(tm) HIV-1 Genotyping System. This IDE authorizes Applied Biosystems to use the ViroSeq system in further clinical trials involving HIV-1 resistance testing of HIV-1 infected patients.

Applied Biosystems is currently conducting clinical trials to prepare the ViroSeq HIV-1 Genotyping System for a 510(k) submission to the FDA that would seek market clearance of the system as an in vitro diagnostic tool with a Class II Medical Device designation. The company designed the separate, parallel IDE clinical trials so that they would yield data for a subsequent 510(k) submission, with the goal of expanding the use of the product into new clinical diagnostic uses. Applied Biosystems anticipates enrolling patients in IDE clinical trials early this calendar year.

The IDE clinical trials have three clinical objectives: (1) to investigate the impact of secondary mutations upon clinical expert interpretation of expected drug resistance; (2) to determine if clinical expert opinion offers a different interpretation of drug resistance from that predicted by a rule s-based algorithm; and (3) to measure the prevalence of secondary and other mutations in a select population of HIV-1 patients.

"The approval of our IDE application acknowledges that our proposed clinical trials meet FDA standards for human safety and confidentiality, and that the clinical protocol is appropriate," said Tony C. Lam, senior manager for regulatory affairs and quality assurance at Applied Biosystems. "If data from the upcoming clinical trials validate our preliminary findings, the ViroSeq system may have a significant impact on the management of HIV-1 drug resistance treatment by identifying the mutant HIV-1 virus infecting the patient, once a 510(k) presenting the IDE derived data is cleared by FDA.

"HIV-1 virus mutates rapidly, which greatly compromises the efficacy of drug regimens. 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. They would no longer need to depend on time -consuming, trial-and-error methods of prescribing various anti-HIV drugs a nd waiting to see how effective they are," he added.

The ViroSeq system that will be used for the IDE clinical trials will be appropriately labeled: "For Investigational Use Only (IUO). The performance characteristics of this assay have not been established." Applied Biosystems will provide the study protocol to clinical laboratories interested in participating in the IDE clinical trials. Laboratories performing research studies can also obtain the research configuration of the product, which will be appropriately labeled: "For Research Use Only (RUO). Not for use in diagnostic procedures."

Genotyping as a method of resistance testing is now accepted as a Standard of Care for HIV therapy by laboratories and clinicians throughout the world By sequencing the strain of HIV-1 virus infecting the patient, the ViroSeq system under the IDE is being investigated as a potential diagnostic test that could offer clinicians information not provided by existing diagnostic sources such as the patient history. The system targets protease and reverse transcriptase genes in the HIV-1 virus that spontaneously develop drug-resistance mutations at a rapid rate.

Applera Corporation, formerly PE Corporation, comprises two operating group s. The Applied Biosystems Group (NYSE: ABI) 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 in order to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.4 billion during fiscal 2000. The Celera Genomics Group (NYSE: CRA), headquartered in Rockville, MD, intends to become the definitive source of genomic and related medical information.

The ViroSeq system used for the IDE clinical trial will be appropriately labeled: "For Investigational Use Only (IUO). The performance characteristics of this assay have not been established."

Clinical laboratories interested in participating in this IDE are welcome to contact Applied Biosystems to obtain the product and protocol.

Laboratories performing research studies can also obtain the product, appropriately labeled: "For Research Use Only (RUO). Not for use in diagnostic procedures."

For more information, call 800.345.5224 or 650.638.5826 or visit http://www.appliedbiosystems.com.
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Publication:Biotech Equipment Update
Date:Mar 1, 2001
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