Dobrin Nedelkov (Presenter)
Arizona State University
Bio: Before coming to ASU in 2013, Dr. Nedelkov spent 14 years at Intrinsic Bioprobes performing research and development in the field of proteomics and protein biomarkers. Prior to joining Intrinsic Bioprobes in 1999, Dr. Nedelkov was Postdoctoral Associate at Yale University, in the Department of Molecular Biophysics and Biochemistry. Dr. Nedelkov received his Ph.D. in Chemistry and Biochemistry from Arizona State University in 1997. Dr. Nedelkov has authored over 80 peer reviewed scientific articles, edited a book on New and Emerging Proteomics Techniques, presented at over 50 scientific meetings, and has 4 issued patents and several pending patent applications.
Authorship: Dobrin Nedelkov
Biodesign Institute, Arizona State University
| Short Abstract Mass spectrometry (MS)–based approaches have produced an increasing number of protein biomarker candidates. Yet, vast majority of these biomarkers have not been validated and translated into routine lab tests. To date, there are less than a dozen MS-based protein clinical lab tests. Discussed here will be the key aspects for development, validation and translation of MS-based lab tests into the clinical laboratory: the demand, end-users, platforms, sample preparation, design, validation, and regulatory issues. An emphasis on content, simplicity, and cost seems to be critical for clinical adoption of MS-based protein lab tests. Some possible killer-apps and solutions will be discussed. |
Long Abstract
Mass spectrometry (MS)–based approaches have produced an increasing number of protein biomarker candidates. Yet, vast majority of these biomarkers have not been validated and translated into routine lab tests. To date, there are less than a dozen MS-based protein clinical lab tests. Given in this presentation will be a brief historical perspective and current developments in protein mass spectrometry, with more focus on the key aspects for the development, validation and translation of MS-based lab tests. Among the factors for considerations are:
• Demand: Is there a need, and can MS-based protein tests deliver more content than enzymatic immunoassays?
• End-users: Who are the customers - reference labs, public health labs, hospital labs, or point-of-care sites?
• Platforms: Can simpler, user-friendly instrumentation contribute to faster acceptance?
• Sample preparation: Is this the bottleneck, and how can it be simplified?
• Design: Are current complex MS-approaches workflows hindering widespread adoption?
• Validation: How rigorous should it be, and how to eliminate variability issues?
• Regulatory: What is the best way for achieving regulatory compliance?
Considering all of the above, it seems that an emphasis on content, simplicity, and cost is critical for clinical adoption of MS-based protein lab tests. Some possible killer-apps and solutions will be discussed.
References & Acknowledgements:
| Description | Y/N | Source |
| Grants | no | |
| Salary | no | |
| Board Member | no | |
| Stock | no | |
| Expenses | no |
IP Royalty: no
| Planning to mention or discuss specific products or technology of the company(ies) listed above: | no |