title: Microfluidic strategies applied to biomarker discovery and validation for multivariate diagnostics.
abstract: Complex diseases are caused by combinatorial genetic, environmental and lifestyle factors. The emergence of multibiomarker tests to define these diseases and to identify the early, presymptomatic stages offers several advantages to the conventional use of single marker tests. The development of multibiomarker protein-based tests remains constrained by technological and operational limitations in assaying hundreds to thousands of proteins in thousands of samples. In order to develop a multibiomarker test that stratifies risk for Type 2 diabetes, we took a candidate-driven immunoassay approach utilizing a microfluidics platform to analyze 89 candidate proteins in thousands of samples, which allowed us to move from discovery to a commercial test in 2 years. Future multibiomarker test development will be enhanced by advancements in the number of proteins that can be analyzed, analytical sensitivity and throughput, and sample volume requirements, all of which depend on the further advancement of microfluidics, detection technologies and affinity-based reagents.
authors: Tethys Bioscience, 5858 Horton Street, Emeryville, CA 94608, USA. ttarasow@tethysbio.com
authors: Theodore M
authors: TM
authors: Tarasow
authors: Laura
authors: L
authors: Penny
authors: Anil
authors: A
authors: Patwardhan
authors: Sarah
authors: S
authors: Hamren
authors: Michael P
authors: MP
authors: McKenna
authors: Mickey S
authors: MS
authors: Urdea
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D002908:Chronic Disease; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000378:metabolism; D006801:Humans; D044085:Microfluidics / Q000379:methods*; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011506:Proteins / Q000032:analysis; D015203:Reproducibility of Results; D012107:Research Design
chemical_list: D015415:Biomarkers; D011506:Proteins