Future of clinical proteomics: could targeted multi-protein panels supplant low-throughput methods?

Mass spectrometry (MS)-based proteomics, especially the targeted applications, hold great potential as Laboratory Developed Tests (LDTs) for clinical applications. They are suitable for widespread clinical use due to their impressive sample/protein multiplexing capabilities, analytical sensitivity and replicability, adaptability to diverse clinical samples, and highly evolved sample processing protocols. Although multiple LDTs have been developed and approved by regulatory agencies, various areas still need improvement.

This article focuses on introducing MS-based LDT as a potential clinical technology, its superiority over low-throughput or antibody-based methods, existing hurdles in the adoption of such LDTs in clinics, what they can adopt to, and regulatory and analytical considerations that need to be addressed to develop a robust MS-based LDT.

Recent efforts to optimize instrumentation and sample preparation for MS-based applications have made these LDTs promising contenders for clinical utilization. With focused research to answer quality assessment requirements, data interpretability, method scalability, and ease of use, MS-based LDTs can revolutionize clinical diagnostics. Drawing parallels to other omics technologies, these LDTs can address the long-standing multiplexing hinge and further establish multi-protein diagnostics as next-generation diagnostics of low-throughput methods.