Selection and analytical validation of biomarker detection technique(s)
Working group 1 will develop a consensus on what biomarker detection technique should be used for specific biomarkers in COPD and biomarkers in general. In addition, it will develop a consensus on how detection techniques should be validated to achieve reproducible detection of biomarkers. Ultimately, Working Group 1 will produce a development plan for biomarkers in COPD and a BBP whitepaper on the selection and analytical validation of biomarker detection techniques to ensure standardized and reproducible biomarker detections for each class of biomarker throughout Europe.
To establish a development plan for biomarkers in COPD
To establish a BBP whitepaper for selection and analytical validation of detection techniques.
To evaluate and select types of mass spectrometry techniques, protein multiplex techniques and high-throughput immune-based techniques that are used to measure protein biomarkers, and of different types of source material that are used for analytical validation of the detection techniques, including evaluation of existing guidelines.
To evaluate and select read-out parameters used as criteria for analytical validation of detection techniques for each ranked biomarker (e.g. detection limit, variability, duration of test, high-throughput potential, cost), including evaluation of existing guidelines.
To integrate considerations, including FDA and EMA guidelines for eventual market
approval, and identified hurdles and solutions for biomarker detection tests and technical
validation to define a BBP guideline for:
Selection of detection technique and source material for each class of protein biomarker
Selection and analytical validation of biomarker detection techniques for each class of
To develop a whitepaper for BBP for selection and analytical validation of biomarker detection
To identify technical bottlenecks in the methods that will be included in the BBP whitepaper.
To set up new research proposals to develop solutions for the technical bottlenecks in the
These tasks will be organized through video conferences
Tasks 2 & 3
Short-Term Scientific Missions (STSM)
Tasks 4 & 6
a scientific symposium
Tasks 4 & 6
development of dissemination material and scientific publications
BBP guidelines on biomarker detection techniques.
New research proposals to develop solutions for technical bottlenecks.
publication of bbp white paper on biomarker detection techniques