Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis

Jason D. Theis, Surendra Dasari, Julie A. Vrana, Paul J. Kurtin, Ahmet Dogan

Research output: Contribution to journalReview articlepeer-review

44 Scopus citations


Shotgun proteomics technology has matured in the research laboratories and is poised to enter clinical laboratories. However, the road to this transition is sprinkled with major technical unknowns such as long-term stability of the platform, reproducibility of the technology and clinical utility over traditional antibody-based platforms. Further, regulatory bodies that oversee the clinical laboratory operations are unfamiliar with this new technology. As a result, diagnostic laboratories have avoided using shotgun proteomics for routine diagnostics. In this perspectives article, we describe the clinical implementation of a shotgun proteomics assay for amyloid subtyping, with a special emphasis on standardizing the platform for better quality control and earning clinical acceptance. This assay is the first shotgun proteomics assay to receive regulatory approval for patient diagnosis. The blueprint of this assay can be utilized to develop novel proteomics assays for detecting numerous other disease pathologies.

Original languageEnglish (US)
Pages (from-to)1067-1077
Number of pages11
JournalJournal of Mass Spectrometry
Issue number10
StatePublished - Oct 2013


  • amyloidosis
  • clinical
  • diagnostic test
  • mutant protein
  • proteomics
  • spectrometry
  • tandem mass

ASJC Scopus subject areas

  • Spectroscopy


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