Technical and Other Barriers Impeding the Expansion of the Clinical Plasma Proteome
Tue 11:30 AM - Track 2: Discovery Proteomics
Leigh Anderson
Plasma Proteome Institute
Leigh Anderson, Plasma Proteome Institute
The current clinical plasma proteome consists of 109 proteins measured by FDA-cleared or approved assays and 96 proteins measured using widely-available laboratory developed tests, in total about 1% of the baseline human proteome. However, the rate at which new protein analytes achieve FDA approval has remained essentially constant over the past 15 years at 1.5 proteins per year - insufficient to meet clear medical needs. While most recent discussion of this shortfall has focused on bottlenecks in the biomarker pipeline (generally the difficulty and under-resourcing of verification studies), there are numerous additional economic, structural and scientific issues that impede the emergence of useful new tests.

Opening these issues to debate in the clinical biomarker community should lead to a greater involvement of clinical laboratorians in all phases of biomarker research and specifically in the development of an effective strategy to expand the value of protein diagnostics.