The technology involved in commercial immunoassay products (past and present) is described primarily in a chronological sequence, with each significant development explained with the key products associated with it. The over-riding driver for the obsolescence and replacement of successful products in the market was the elimination of steps previously carried out by the user. Fluorescence-labeled antibody and agglutination methods are first described, followed by radioimmunoassay and immunoradiometric assay. Key technology changes came about through solid phases and enzyme labels. Homogeneous immunoassays were a major development, particularly in drug detection. Many advances were in automation, with chemistry developments aimed at simplifying the design of automated equipment. New technology only succeeded when the performance of previous products could be matched while achieving simpler operation. The trend to run immunoassays on common platforms with clinical chemistry tests, such as glucose, is explained. Near-patient and home-use tests have alternative technology paths, with distinctly different requirements. Finally, technology advances that are important in life-science research are described.

David Wild’s career spans 40 years in diagnostics, medical devices, pharmaceuticals and biotechnology. As a University of London undergraduate, he won the Driver Prize for Biochemistry after discovering an extra electron transfer step in photosynthesis. As leaders of the University Biochemistry Society, he and his girlfriend Cindy (now wife) hosted lectures by Sir Hans Krebs and Roger Ekins. After graduation, he worked first as a molecular biologist at a pharmaceutical company R&D laboratory, then, for 25 years, in immunodiagnostics, managing product development and industrial engineering projects. More recently he managed large medical device R&D and operational projects. He worked for Amersham, Kodak, Johnson and Johnson, Bristol-Myers Squibb and ConvaTec. His Director level positions include Research and Development, Design Engineering, Global Manufacturing, and Strategy. He indulges his passion for immunoassays as Managing Editor of The Immunoassay Handbook and lectures, trains and consults on development, manufacturing and marketing strategies, and how to integrate and execute them.

Chris Sheehan is an experienced and effective Healthcare Commercial Coach/Consultant/Interim, with a strong Sales and Marketing track record in large corporate, international, diagnostics and capital markets. He is expert in all aspects of sales processes and CRM implementation and has coached high growth companies in planning for and achieving strong sales in business-to-business markets. Has worked with pre-start and SMEs (small to medium sized enterprises) in healthcare and has carried out several assignments at incubators internationally mentoring start-ups, creating business and marketing plans and project managing commercialization. Chris enjoys motivating and persuading people, whether in international project teams, as line manager or in customer and opinion leader consultative selling settings to achieve business results and people development. Previously with Johnson and Johnson, Chris works with Oxford Innovation as well as leading a breast cancer start-up and work for Fleet Bioprocessing.

Steven Binder is the Senior Director of Technical Development for the Clinical Diagnostic Group at Bio-Rad Laboratories. He joined Bio-Rad in 1983, where he initially developed and introduced clinical chromatography methods used for catecholamine measurement and hemoglobinopathy screening. He served Bio-Rad as R&D manager for clinical chromatography from 1988 to 1998 and was closely involved in the development of new methods for diabetes monitoring and clinical toxicology. From 1998-2005, he led the development of a fully automated platform for multiplex immunoassay, with an emphasis on autoimmune and infectious diseases. His current work involves the evaluation of novel multiplex and digital technologies, as well as validation and commercial development of new biomarkers.

Steve received a B.A. in History and Science, magna cum laude, from Harvard University. He has authored over 25 papers in peer-reviewed journals and has received 11 US patents.

Immunoassay, fluorescence, fluorescence microscopy, fluorescence-activated cell sorter, slide agglutination, latex agglutination, precipitin, radial immunodiffusion, immunoelectrophoresis, nephelometry, turbidimetry, radioimmunoassay, immunoradiometric assay, liquid phase, solid phase, enzyme immunoassay, enzyme-linked immunosorbent assay (ELISA), homogeneous immunoassay, fluorescence polarization, radial partition immunoassay, time-resolved fluorescence, enhanced luminescence, automation, analyzer, random access, primary tube, test menu, microsphere, multiplex, near-patient, home use, point-of-care, lateral flow.