1. Demise of Polymerase Chain Reaction/Electrospray Ionization-Mass Spectrometry as an Infectious Diseases Diagnostic Tool.
- Author
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Özenci, Volkan, Patel, Robin, Ullberg, Måns, and Strålin, Kristoffer
- Subjects
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INFECTION , *MASS spectrometry , *MICROBIAL sensitivity tests , *POLYMERASE chain reaction , *GENOMICS , *LABORATORY equipment & supplies , *DIAGNOSIS - Abstract
Although there are several US Food and Drug Administration (FDA)-approved/cleared molecular microbiology diagnostics for direct analysis of patient samples, all are single target or panel-based tests. There is no FDA-approved/cleared diagnostic for broad microbial detection. Polymerase chain reaction (PCR)/electrospray ionization-mass spectrometry (PCR/ESI-MS), commercialized as the IRIDICA system (Abbott) and formerly PLEX-ID, had been under development for over a decade and had become CE-marked and commercially available in Europe in 2014. Capable of detecting a large number of microorganisms, it was under review at the FDA when, in April 2017, Abbott discontinued it. This turn of events represents not only the loss of a potential diagnostic tool for infectious diseases but may be a harbinger of similar situations with other emerging and expensive microbial diagnostics, especially genomic tests. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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