@article{00c12b84503944e499d595873abb70b6,
title = "Demise of Polymerase Chain Reaction/Electrospray Ionization-Mass Spectrometry as an Infectious Diseases Diagnostic Tool",
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.",
keywords = "PCR, bacteremia, diagnostics, mass spectrometry, sepsis",
author = "Volkan {\"O}zenci and Robin Patel and M{\aa}ns Ullberg and Kristoffer Str{\aa}lin",
note = "Funding Information: Potential conflicts of interest. R. P. reports grants from CD Diagnostics, BioFire, Curetis, Merck, Hutchison Biofilm Medical Solutions, Accelerate Diagnostics, Allergan, and The Medicines Company. R. P. is a consultant to Curetis; monies are paid to Mayo Clinic. In addition, R. P. has a patent on Bordetella pertussis/parapertussis PCR issued, a patent on a device/method for sonication with royalties paid by Samsung to Mayo Clinic, and a patent on an anti-biofilm substance issued. R. P. serves on an Actelion data monitoring board. R. P. receives travel reimbursement from the American Society for Microbiology (ASM), and the Infectious Diseases Society of America (IDSA), an editor{\textquoteright}s stipend from ASM and IDSA, and honoraria from the NBME, Up-to-Date and the Infectious Diseases Board Review Course. All other authors have no reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Funding Information: The Food and Drug Administration (FDA) trial in which the authors participated was funded by Abbott. Abbott provided instrumentation, test kids, and reagents for the Early Assessment Studies of the IRIDICA assay, that is, 2 studies on bronchoalveolar lavage, and 1 study on sterile fluids/tissues. In addition, Abbott provided test kits for studies on blood, related to the FDA trial. Funding Information: Financial support. The Food and Drug Administration (FDA) trial in which the authors participated was funded by Abbott. Abbott provided instrumentation, test kids, and reagents for the Early Assessment Studies of the IRIDICA assay, that is, 2 studies on bronchoalveolar lavage, and 1 study on sterile fluids/tissues. In addition, Abbott provided test kits for studies on blood, related to the FDA trial. Publisher Copyright: {\textcopyright} The Author(s) 2017.",
year = "2018",
month = jan,
day = "18",
doi = "10.1093/cid/cix743",
language = "English (US)",
volume = "66",
pages = "452--455",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "3",
}