DiagnosticsAbbott Introduces Molecular Diagnostic System Intended For Broad Identification Of Infectious Agents
Abbott (NYSE: ABT) unveiled its new PLEX-ID system currently in development for detecting and characterizing a wide range of pathogens, including infectious agents commonly transmitted in hospitals and other clinical sites. PLEX-ID is the next generation of Abbott"s Ibis T5000™ Biosensor System and is among an innovative portfolio of instruments and tests the company is featuring this week at the American Association for Clinical Chemistry"s 2009 Clinical Lab Expo.
"Research reported in several scientific venues has shown that the Ibis technology could offer applications for the rapid detection of a broad range of microbes, including bacteria, viruses and fungi, in a variety of specimens," said David Ecker, Ph.D., divisional vice president, research and development, Abbott Molecular.
Currently intended to be for research use only, PLEX-ID is a high-throughput technology that simultaneously enables identification and recognition of emerging organisms using a unique combination of both PCR (polymerase chain reaction) and mass spectrometry analysis for detection of microbes.
The system is designed to address a significant unmet clinical need by providing results in six to seven hours instead of three or more days as is required with culturing methods.
"The Ibis technology has demonstrated broad utility in a variety of research applications, including biodefense, forensics, epidemiology and infectious disease surveillance for public health applications," said Stafford O"Kelly, head of Abbott"s molecular diagnostics business. "We believe the technology has the potential to be a powerful and versatile tool, particularly for the identification of hospital-borne pathogens."
The PLEX-ID is expected to receive CE Mark (Conformitç© Europç©enne) for marketing in the European Union later this year.
Initial assays in development include bacteria-candida-antibiotic resistance (BCA), influenza and broad viral detection.
In an early research study, viral isolates from adenovirus, alphavirus, enterovirus, flavivirus, herpes virus and human parvovirus B19 were injected into human plasma specimens from healthy volunteers. This was followed by a retrospective study of 54 blinded samples of cerebral spinal fluid, urine and plasma. The Ibis technology detected all viral pathogens that were added to the plasma specimens with a limit of detection ranging from 15 to 125 copies. In the retrospective study, the system demonstrated 98 percent concordance with the reference method.
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