Abstract

The Future of Mass Spectrometry-based Protein Clinical Tests

Dobrin Nedelkov, Research Scientist, Arizona State University

Mass spectrometry has played an important role in protein biomarkers discovery. Yet, very few of those candidate biomarkers have been validated, and mass spectrometry-based protein tests have not found their way into clinical laboratories. To date, there are less than a dozen MS-based protein clinical tests, all of them in a form of lab developed tests (LDTs). Offered in this presentation is a unique perspective on the future of mass spectrometry protein tests, in view of the following determinants: the true demand for such clinical tests, end-users requirements, platforms and systems design, sample preparation bottlenecks, analytical and clinical validation, and regulatory approval. Fresh thoughts and attitudes toward these tests are required in order to move them toward clinical utilization and diagnostic use en masse, with critical emphasis on content, simplicity, and cost. Some possible killer-apps and solutions will be discussed.