Step 1 |
Identify an important disease where improved diagnosis would change clinical management and make a measurable difference in outcome. |
Step 2 |
Optimize SELDI conditions for the most relevant biological sample available using select groups of patients that either have or do not have the disease based on very strict clinical and/or laboratory criteria. |
Step 3 |
Learn proteomic profiles and identify the best discriminative combination of biomarkers (PROTEME). |
Step 4 |
Using customized bioinformatics algorithms transform the proteomic information of the PROTEME into a numeric variable (PROTEOMIC SCORE) which can be further manipulated using regular statistics. |
Step 5 |
Evaluate the SCORE by blind testing in the population used for its development and measure intra and inter-rater variability. |
Step 6 |
Evaluate prospectively the SCORE against relevant outcome measures in a population different than that used for its development. |
Step 7 |
Identify component biomarkers using various proteomics methods. |
Step 8 |
Extend pathophysiological understanding of the disease using hypothesis driven approaches stemmed from knowledge of identity of biomarkers or protein precursors. |