At the Association for Mass Spectrometry's Applications to the Clinical Lab meeting this week, proteomics researchers highlighted the need for higher-throughput assays, with several introducing automated SISCAPA workflows employing instruments from vendors including Agilent Technologies and Thermo Fisher Scientific.
Attention to assay reproducibility and selection of appropriate intended use populations will be key to the success of proteomics-based tests, FDA staff fellow Joshua Levin suggested at a talk this week discussing the agency's review of two mock submissions for protein IVDMIAs.
With diagnostic development shifting from single-marker to multi-marker tests, multiple-reaction monitoring mass spectrometry has emerged as a potentially valuable clinical tool. Further improvements in the platform's cost and variability are needed, however, to make it competitive with immunoassays.
Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.