Abstract
From Research to Clinical Application Multi-Parameter Testing: Marker Panels for the Early Detection of Complex DiseasesMulti Parameter Analysis can open novel diagnostic opportunities for the early diagnosis and screening of multimodal diseases like cancer. Single proteins have so far failed to describe such complex diseases. Being able to screen with a set of analytes is one promising way to overcome the present limitations. Various marker identification tools including proteomics approaches have been successfully applied to identify new screening markers for early detection of colorectal cancer (CRC). CRC is one of the most incident cancers worldwide and early detection is clearly a key factor in reducing mortality from CRC. Several screening methods are recommended, including colonoscopy, fecal occult blood testing (FOBT) and fecal DNA analysis. Of these annual stool testing with the guaiac based FOBT is most often applied, in spite of limitations such as low sensitivity and dietary influences. Though proce dures with improved performance eg. immunolo gical FOBT are available, a screening assay for CRC in serum that could easily be integrated in any health check-up would be highly welcome. A positive result of such a test would trigger a follow-up colonoscopy for an exact diagnosis. In this review we will cover aspects of marker identification strategies and describe a well structured marker validation process that is based on clinically characterized sample materials. Finally the value of analytical multi-parameter platforms enabling the combination of multi markers in routine diagnostics settings is outlined. An appropriate multi-parameter immunochemistry platform concept, currently developed under the working name »IMPACT« will be introduced.
Highlights
Being able to screen with a set of analytes is one promising way to overcome the present limitations
Though procedures with improved performance eg. immunological fecal occult blood testing (FOBT) are available, a screening assay for colorectal cancer (CRC) in serum that could be integrated in any health check-up would be highly welcome
A positive result of such a test would trigger a follow-up colonoscopy for an exact diagnosis
Summary
OD ISTRA@IVANJA DO KLINI^KE PRIMENE: PANELI MARKERA ZA RANU DETEKCIJU SLO@ENIH BOLESTI. In consequence the discovery phase is overrated if a program in proteomics is limited to the identification of novel validated biomarkers with a clearly defined position in in vitro diagnostics. We designed a two-step approach to assess the diagnostic potential of the marker candidates: using optimized ELISA prototypes we measure 50 highly characterized samples from diseased individuals and 50 samples from healthy blood donors. This limited »black and white panel« (panel A) is the second qualifier in the process to advance a marker candidate to the status of a validated marker. Identification of marker candidates proteomics methods, Affymetrics data, pathway analysis, public domain, collaborations
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