These developments presage major positive changes in the role of proteins in clinical medicine. Today, a newly discovered protein biomarker candidate languishes in the pages of a journal until someone finds funding to create a relatively crude immunoassay. Then, if two or three clinical studies show promise, one of the IVD companies that control hospital analyzer platforms may embark on an effort to develop an FDA-approvable immunoassay through a process that can take two to four years and cost $3–5 million per protein. The entire process, in the rare success cases, takes a decade or more.
However a much more rational alternative path is emerging based on the ability of automated affinity-MS platforms to simultaneously fill roles in Type 2 biomarker research, clinical evaluation of candidates, and finally, in the clinical lab itself. Common instrument platforms justify greater investments in performance and automation and, ultimately, lower cost per result.
Current evidence supports the notion that the same assay reagents (antibodies and internal standards) may also suffice from research to clinic, albeit with increasing levels of quality and regulatory documentation.
Thus, the technical barriers limiting translation of candidate biomarkers can be radically reduced, and several disconnected steps of the current process removed. With these improvements, and assuming the availability of stored samples appropriate to the specific clinical questions at hand, it will be feasible to test thousands of candidate biomarkers, and to translate the successes into clinical use in something on the order of five years.
Of even greater long-term significance is the change this could bring about in the economics of healthcare. MS-based analysis provides a very low incremental cost per protein analyte once a sample is in process, as opposed to testing of each protein in separate aliquots in current clinical-quality immunoassay instruments. This paradigm change makes the development of multiplex tests more practical and less expensive, opening the way to successful tests for more complex and heterogeneous diseases including cancer.
The positive economic impact of early disease detection at reasonable cost is enormous, and justifies substantial efforts to re-engineer our currently unproductive biomarker pipeline.