title: A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics.
abstract: Rapid innovation in (epi)genetics and biomarker sciences is driving a new drug development and product development pathway, with the personalized medicine era dominated by biologic therapeutics and companion diagnostics. Companion diagnostics (CDx) are tests and assays that detect biomarkers and specific mutations to elucidate disease pathways, stratify patient populations, and target drug therapies. CDx can substantially influence the development and regulatory approval for certain high-risk biologics. However, despite the increasingly important role of companion diagnostics in the realization of personalized medicine, in the USA, there are only 23 Food and Drug Administration (FDA) approved companion diagnostics on the market for 11 unique indications. Personalized medicines have great potential, yet their use is currently constrained. A major factor for this may lie in the increased complexity of the companion diagnostic and corresponding therapeutic development and adoption pathways. Understanding the market dynamics of companion diagnostic/therapeutic (CDx/Rx) pairs is important to further development and adoption of personalized medicine. Therefore, data collected on a variety of factors may highlight incentives or disincentives driving the development of companion diagnostics. Statistical analysis for 36 hypotheses resulted in two significant relationships and 34 non-significant relationships. The sensitivity of the companion diagnostic was the only factor that significantly correlated with the price of the companion diagnostic. This result indicates that while there is regulatory pressure for the diagnostic and pharmaceutical industry to collaborate and co-develop companion diagnostics for the approval of personalized therapeutics, there seems to be a lack of parallel economic collaboration to incentivize development of companion diagnostics.
authors: Department of Biological Basis of Behavior, University of Pennsylvania Phildephila, PA, USA.
authors: Dee
authors: D
authors: Luo
authors: The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation, University of OxfordOxford, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordOxford, UK.
authors: James A
authors: JA
authors: Smith
authors: Kinapse, Wimbledon London, UK.
authors: Nick A
authors: NA
authors: Meadows
authors: National Institute of Health Research, Biomedical Research Centre, Molecular Diagnostic Centre, Oxford University Hospitals Oxford, UK.
authors: A
authors: A
authors: Schuh
authors: Department of Biochemical Engineering, University College London London, UK.
authors: Katie E
authors: KE
authors: Manescu
authors: Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford Oxford, UK.
authors: Kim
authors: K
authors: Bure
authors: Sartorius Stedim Göttingen, Germany.
authors: Benjamin
authors: B
authors: Davies
authors: The UCL School of Pharmacy, University College London London, UK.
authors: Rob
authors: R
authors: Horne
authors: SENS Research Foundation Mountain View, CA, USA.
authors: Mike
authors: M
authors: Kope
authors: Stem Cell and Cellular Therapeutics Operations at Stanford University Hospital and Clinic Stanford, CA, USA.
authors: David L
authors: DL
authors: DiGiusto
authors: Stem Cell and Cellular Therapeutics Operations at Stanford University Hospital and ClinicStanford, CA, USA; The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation, University of OxfordOxford, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordOxford, UK; USCF-Stanford Center of Excellence in Regulatory Science and InnovationSan Francisco, CA, USA; Centre for Behavioural Medicine, UCL School of Pharmacy, University College LondonLondon, UK; Harvard Stem Cell InstituteCambridge, MA, USA.
authors: David A
authors: DA
authors: Brindley
keywords: clinical adoption; combinational therapy; companion diagnostic; healthcare risk management; healthcare translation; personalized medicine; risk:benefit appraisal; stratified medicine