Demise of Polymerase Chain Reaction/Electrospray Ionization-Mass Spectrometry as an Infectious Diseases Diagnostic Tool

Clin Infect Dis. 2018 Jan 18;66(3):452-455. doi: 10.1093/cid/cix743.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bacteremia / diagnosis
  • Communicable Diseases / diagnosis*
  • Humans
  • Molecular Diagnostic Techniques / standards
  • Polymerase Chain Reaction*
  • Sepsis / diagnosis
  • Spectrometry, Mass, Electrospray Ionization*
  • United States
  • United States Food and Drug Administration