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Abbott Molecular ID System to be Used in Five-State Biopreparedness Evaluation Program: In-Depth

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Abbott said today that its Plex-ID system for molecular identification and characterization of emerging infectious organisms is being used as part of a biopreparedness evaluation program in collaboration with the Association of Public Health Laboratories and five state public health labs.

The goal of the biopreparedness evaluation program is to demonstrate how the Plex-ID system can help public health authorities identify and characterize a wide range of microorganisms in surveillance activities for infectious diseases, food safety analysis, and biodefense readiness.

Abbott's announcement coincided with the opening of the new 81,000-sq.-ft.Unified State Lab for the Utah Department of Health, one of the five participating public health labs. The other participating state public labs are in Oklahoma, Minnesota, New York, and Virginia.

Abbott launched the Plex-ID system last summer as the next-generation version of its Ibis T5000 Biosensor system. The system combines automated sample preparation, PCR amplification, electrospray ionization mass spectrometry, and information management to rapidly characterize known and unknown organisms. Abbott said the system can provide test results in six to seven hours instead of three or more days as required with other laboratory methods.

Plex-ID can identify a broad range of bacteria, viruses, fungi, and certain parasites, and provide information about drug resistance, virulence, and strain type, according to the company. Anticipated public health applications include epidemiologic surveillance, monitoring pandemic diseases, and identifying emerging or previously unknown agents. The system also is being used for forensic characterization of human samples.

"The high-throughput technology offers our laboratory rapid detection and correct identification of a broad range of pathogens," David Sundwall, executive director of the Utah Department of Health, said in a statement. "The Plex-ID system permits real-time surveillance, rather than identifying a new pathogen long after it first emerges."

Although the platform is not cleared for diagnostic use, Abbott is developing "a wide variety of assays for clinical diagnosis of infectious diseases which remain inadequately served by current methods," Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement.

Abbott said that it has begun to collect specimens and install instruments at clinical trial sites, and that Plex-ID is expected to meet all the requirements for CE Marking in the European Union by June. The company had previously stated last July, when Plex-ID was launched, that it had expected CE Mark designation by the end of 2009.