Evidence map›Paper›PMID 26858745›Full record

ArticleFrontiers in genetics2015

A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics.

Dee Luo, James A Smith, Nick A Meadows, A Schuh, Katie E Manescu, Kim Bure, Benjamin Davies, Rob Horne, Mike Kope, David L DiGiusto and 1 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Frontiers in genetics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Identification of genetic variants affecting reproduction traits in Vrindavani cattle.Mammalian genome : official journal of the International Mammalian Genome Society · 2024
    Article
  4. Review
  5. Review
  6. Applications of molecular testing in surgical pathology of the head and neck.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2017
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 3 countries.

Dee LuoDepartment of Biological Basis of Behavior, University of Pennsylvania Phildephila, PA, USA.
James A SmithThe 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.
Nick A MeadowsKinapse, Wimbledon London, UK.
A SchuhNational Institute of Health Research, Biomedical Research Centre, Molecular Diagnostic Centre, Oxford University Hospitals Oxford, UK.
Katie E ManescuDepartment of Biochemical Engineering, University College London London, UK.
Kim BureBotnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford Oxford, UK.
Benjamin DaviesSartorius Stedim Göttingen, Germany.
Rob HorneThe UCL School of Pharmacy, University College London London, UK.
Mike KopeSENS Research Foundation Mountain View, CA, USA.
David L DiGiustoStem Cell and Cellular Therapeutics Operations at Stanford University Hospital and Clinic Stanford, CA, USA.
David A BrindleyStem 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.
Nuffield Orthopaedic Centre · GBUniversity College London · GBSartorius (Germany) · DESENS Research Foundation · USStanford University · USUniversity of Oxford · GBUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

clinical adoptioncombinational therapycompanion diagnostichealthcare risk managementhealthcare translationpersonalized medicinerisk:benefit appraisalstratified medicine

Identifiers

PMID26858745
PMCPMC4730156
OpenAlexW2249286958

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.