= Emerging. More than 5 years before clinical availability. |
= Expected to be clinically available in 1 to 4 years. |
= Clinically available now. |
Topic: Proteomics
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Short Abstract Clinical proteomics, the application of proteome analysis to clinical purpose, represents a major field in the area of proteome research. The aim of clinical proteomics is the improvement of clinical care based on (1) the identification and application of biomarkers, and (2) the suggestion of relevant therapeutic targets. These two areas have different requirements regarding specimens to be employed, technology, and data evaluation. While substantial efforts (especially in biomarker discovery, but also in the identification of therapeutic targets) are evident based on the large number of associated publications, only a few approaches have actually resulted in clinical application. In this presentation, key issues and major challenges in clinical proteomics will be discussed. |
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Long Abstract Clinical proteomics, the application of proteome analysis to clinical purpose, represents a major field in the area of proteome research. The aim of clinical proteomics is the improvement of clinical care based on (1) the identification and application of biomarkers, and (2) the suggestion of relevant therapeutic targets. These two areas have different requirements regarding specimens to be employed, technology, and data evaluation. While substantial efforts (especially in biomarker discovery, but also in the identification of therapeutic targets) are evident based on the large number of associated publications, only a few approaches have actually resulted in clinical application. In this presentation, key issues and major challenges in clinical proteomics will be discussed. Among these are: a) the definition of a clinical need and a context-of-use, b) selection of appropriate samples, sample preparation and analytical platform, c) application of appropriate statistics, d) demonstration of benefit in a well-powered clinical study and e) obtaining regulatory approval and reimbursement, to enable actual implementation. For several conditions and diseases, clinical proteomics has delivered solutions that are already being applied. Most successful developments are based on multi-marker panels that have demonstrated value in large studies (i.e., including at least several hundred patients). The results of these studies are expected to initiate a change in disease assessment: from diagnosis based on existing damage and therapy aiming to prevent deterioration, towards diagnosis based on molecular mechanisms, prior to observations of clinical symptoms, and therapy via correction of molecular anomalies, thereby preventing disease onset. This will also open a path towards personalized precision medicine, where intervention will be guided by molecular mechanisms, not morphological changes. It is becoming clear that the tools required to meaningfully apply clinical proteomics (i.e., potential biomarkers, relevant technology and bio-banked samples) are available. The move from discovery towards validation and application is not only urgently necessary, but within reach. Now, a change in objective, away from additional discovery studies and towards properly testing the plethora of potential biomarkers that have been described, is needed to demonstrate the practical value of clinical proteomics. |
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References & Acknowledgements:
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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 |