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Preanalytical Influences in Clinical Proteomic Studies: Raising Awareness of Fundamental Issues in Sample Banking

Cancer Research UK Clinical Centre, St James’s University Hospital, Beckett Street, Leeds LS9 7TF, UK, Fax +44 113 2429886, E-mail r.banks@leeds.ac.uk

The first 20% of the full text of this article appears below.

The discovery of new diagnostic markers has been limited for many years, and new biomarkers that can be used for treatment selection and monitoring are also needed. Proteomic-based studies offer real hope of new marker discovery (1)(2), but many challenges remain and progress has been much slower than expected (2)(3)(4)(5). Many initially promising studies have not been followed by wider-scale validation and application. Why has the rate of attrition of potential markers been so high? The process of taking validated biomarkers through to clinical use is a major logistical and financial challenge in its own right (2)(3)(4)(5), but the limiting factors are even more fundamental. The 2 reports by McLenna and colleagues (6)(7) provide examples of how preanalytical factors can contribute to the lack of fulfillment of initial promise. Although based on the use of the SELDI platform, the thought-provoking results reported in this issue of Clinical Chemistry apply in principle to all clinical proteomic studies, irrespective of analytical platform and disease area.

So, what do these 2 reports show? In 2005, the National Cancer Institute/Early Detection Research Network sponsored a multicenter evaluation of the utility and robustness of SELDI serum . . . [Full Text of this Article]