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.
Original language | English (US) |
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Pages (from-to) | 452-455 |
Number of pages | 4 |
Journal | Clinical Infectious Diseases |
Volume | 66 |
Issue number | 3 |
DOIs | |
State | Published - Jan 18 2018 |
Keywords
- PCR
- bacteremia
- diagnostics
- mass spectrometry
- sepsis
ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases