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Abbott Gets CE Marking In EU To Market PLEX-ID Molecular System And Tests

Abbott (ABT) said it received CE Marking in the European Union to market its rapid, high-throughput PLEX-ID instrument, along with three assays for use on the system: PLEX-ID Viral IC Spectrum, PLEX-ID BAC Spectrum BC and PLEX-ID Flu.

According to the company, PLEX-ID, which is based on molecular diagnostic technologies, addresses a significant unmet need for rapid detection and identification of a broad range of microbes that cause infections in patients. It provides results in less than eight hours instead of the days or even weeks required for traditional culture methods.

The PLEX-ID Viral IC Spectrum assay is designed to detect and identify 11 viral families with more than 250 species of important systemic viral pathogens, including herpes simplex virus, cytomegalovirus, Epstein-Barr virus, human adenovirus, human enterovirus, BK and JC polyomaviruses, and parvovirus B19, directly from plasma specimens.

The PLEX-ID BAC Spectrum BC assay can detect and identify nearly 400 species of bacteria, and also can detect the presence of genetic markers that determine bacterial resistance to certain antibiotics.

The PLEX-ID Flu assay is intended for detection and identification of known influenza A viruses, newly emerging influenza A strains, and influenza B.

Abbott specified that the system's unique advantage is the ability to characterize a very wide range of microorganisms directly from clinical specimen. Thus, the system minimizes both the amount of time and laboratory work required to provide physicians important information they can use to best tailor treatment for the patient.

by RTT Staff Writer

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