Setting clinical performance specifications to develop and evaluate biomarkers for clinical use

Affiliations

• ¹ 1 School of Medicine, University of Notre Dame, Darlinghurst, New South Wales, Australia.
• ² 2 National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia.
• ³ 3 ARC Consulting, Perth, Australia.
• ⁴ 4 Department of Clinical Epidemiology, Biostatistics & Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
• ⁵ 5 Department of Global Public Health and Primary Health Care, University of Bergen, Norway.
• ⁶ 6 The Norwegian Quality Improvement of Primary Care Laboratories (NOKLUS), Haraldsplass Deaconess Hospital, Bergen, Norway.
• ⁷ 7 Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway.
• ⁸ 8 Department of Clinical Biochemistry, The Christie Pathology Partnership, The Christie NHS Foundation Trust, Manchester, UK.
• ⁹ 9 Clinical Chemistry Department, Altnagelvin Hospital, Western Health and Social Care Trust, Londonderry, UK.
• ¹⁰ 10 Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands.
• ¹¹ 11 Clinical Operations, Global Medical and Scientific Affairs, Roche Diagnostics GmbH, Mannheim, Germany.
• ¹² 12 Abbott Diagnostics, Wiesbaden, Germany.
• ¹³ 13 Department of Biomedical Sciences for Health, University of Milano, Milan, Italy.
• ¹⁴ 14 Department of Clinical Chemistry & Endocrinology, Prince of Wales Hospital, New South Wales Health Pathology and School of Medical Sciences, University of New South Wales, Randwick, Australia.
• ¹⁵ 15 School of Public Health, University of Sydney, Camperdown, Australia.