IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v304y2022ics0277953619302862.html
   My bibliography  Save this article

Multi-polar scripts: Techno-regulatory environments and the rise of precision oncology diagnostic tests

Author

Listed:
  • Cambrosio, Alberto
  • Campbell, Jonah
  • Keating, Peter
  • Bourret, Pascale

Abstract

The paper examines the development and marketing of five multi-gene tests, a.k.a. as tumor signatures, designed to aid clinicians and cancer patients in therapeutic decision-making, and, in particular, to avoid overtreatment. We build on a 2011 paper that investigated the emergence of this new domain by opening the ‘black box’ of two pioneering tests and analyzing the hybrid, scientific-regulatory 'scripts' that were built into them. In subsequent years, second-generation tests, produced by a diverse blend of academic and commercial initiatives, have become available, and they all built into their scripts the lessons learned from their predecessors. The present paper confirms the heuristic value of the initial script-analysis but expands it to consider the multi-polar nature of the space within which multigene tests mutually position themselves. We examine how the tests were first problematized — i.e. how they described and prescribed the kind of world in which they would operate — and how their initial problematization was re-specified following the emergence of a comparative arena and their resulting informational enrichment. In parallel, we explore valuation processes, i.e. the evolving definition of the set of referents against which the assays are mutually compared, and the debates about the appropriate criteria for doing so. We note that the cancer diagnostic industry is involved in the reconfiguration of the multi-polar environment defined by socio-technical, techno-scientific, and regulatory matters of concern that seamlessly blend commercial and scientific considerations.

Suggested Citation

  • Cambrosio, Alberto & Campbell, Jonah & Keating, Peter & Bourret, Pascale, 2022. "Multi-polar scripts: Techno-regulatory environments and the rise of precision oncology diagnostic tests," Social Science & Medicine, Elsevier, vol. 304(C).
  • Handle: RePEc:eee:socmed:v:304:y:2022:i:c:s0277953619302862
    DOI: 10.1016/j.socscimed.2019.05.022
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277953619302862
    Download Restriction: Full text for ScienceDirect subscribers only

    File URL: https://libkey.io/10.1016/j.socscimed.2019.05.022?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Charles M. Perou & Therese Sørlie & Michael B. Eisen & Matt van de Rijn & Stefanie S. Jeffrey & Christian A. Rees & Jonathan R. Pollack & Douglas T. Ross & Hilde Johnsen & Lars A. Akslen & Øystein Flu, 2000. "Molecular portraits of human breast tumours," Nature, Nature, vol. 406(6797), pages 747-752, August.
    2. Bourret, Pascale & Keating, Peter & Cambrosio, Alberto, 2011. "Regulating diagnosis in post-genomic medicine: Re-aligning clinical judgment?," Social Science & Medicine, Elsevier, vol. 73(6), pages 816-824, September.
    3. Nelson, Nicole C. & Keating, Peter & Cambrosio, Alberto & Aguilar-Mahecha, Adriana & Basik, Mark, 2014. "Testing devices or experimental systems? Cancer clinical trials take the genomic turn," Social Science & Medicine, Elsevier, vol. 111(C), pages 74-83.
    4. Julia Black, 2008. "Constructing and contesting legitimacy and accountability in polycentric regulatory regimes," Regulation & Governance, John Wiley & Sons, vol. 2(2), pages 137-164, June.
    5. Laura J. van 't Veer & Hongyue Dai & Marc J. van de Vijver & Yudong D. He & Augustinus A. M. Hart & Mao Mao & Hans L. Peterse & Karin van der Kooy & Matthew J. Marton & Anke T. Witteveen & George J. S, 2002. "Gene expression profiling predicts clinical outcome of breast cancer," Nature, Nature, vol. 415(6871), pages 530-536, January.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Swallow, Julia & Kerr, Anne & Chekar, Choon Key & Cunningham-Burley, Sarah, 2020. "Accomplishing an adaptive clinical trial for cancer: Valuation practices and care work across the laboratory and the clinic," Social Science & Medicine, Elsevier, vol. 252(C).
    2. Lingsong Meng & Dorina Avram & George Tseng & Zhiguang Huo, 2022. "Outcome‐guided sparse K‐means for disease subtype discovery via integrating phenotypic data with high‐dimensional transcriptomic data," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 71(2), pages 352-375, March.
    3. Zhiguang Huo & Ying Ding & Silvia Liu & Steffi Oesterreich & George Tseng, 2016. "Meta-Analytic Framework for Sparse K -Means to Identify Disease Subtypes in Multiple Transcriptomic Studies," Journal of the American Statistical Association, Taylor & Francis Journals, vol. 111(513), pages 27-42, March.
    4. Yang, Xi & Hoadley, Katherine A. & Hannig, Jan & Marron, J.S., 2023. "Jackstraw inference for AJIVE data integration," Computational Statistics & Data Analysis, Elsevier, vol. 180(C).
    5. Cambrosio, Alberto & Campbell, Jonah & Keating, Peter & Polk, Jessica B. & Aguilar-Mahecha, Adriana & Basik, Mark, 2022. "Healthcare policy by other means: Cancer clinical research as “oncopolicy”," Social Science & Medicine, Elsevier, vol. 292(C).
    6. Daniel Fitzpatrick & Rebecca Monson, 2022. "Property rights and climate migration: Adaptive governance in the South Pacific," Regulation & Governance, John Wiley & Sons, vol. 16(2), pages 519-535, April.
    7. María Elena Martínez & Jonathan T Unkart & Li Tao & Candyce H Kroenke & Richard Schwab & Ian Komenaka & Scarlett Lin Gomez, 2017. "Prognostic significance of marital status in breast cancer survival: A population-based study," PLOS ONE, Public Library of Science, vol. 12(5), pages 1-14, May.
    8. Yishai Shimoni, 2018. "Association between expression of random gene sets and survival is evident in multiple cancer types and may be explained by sub-classification," PLOS Computational Biology, Public Library of Science, vol. 14(2), pages 1-15, February.
    9. Zemin Zheng & Jie Zhang & Yang Li, 2022. "L 0 -Regularized Learning for High-Dimensional Additive Hazards Regression," INFORMS Journal on Computing, INFORMS, vol. 34(5), pages 2762-2775, September.
    10. Cyril Benoît, 2021. "Politicians, regulators, and regulatory governance: The neglected sides of the story," Regulation & Governance, John Wiley & Sons, vol. 15(S1), pages 8-22, November.
    11. Lian, I.B. & Chang, C.J. & Liang, Y.J. & Yang, M.J. & Fann, C.S.J., 2007. "Identifying differentially expressed genes in dye-swapped microarray experiments of small sample size," Computational Statistics & Data Analysis, Elsevier, vol. 51(5), pages 2602-2620, February.
    12. Yoo-Ah Kim & Stefan Wuchty & Teresa M Przytycka, 2011. "Identifying Causal Genes and Dysregulated Pathways in Complex Diseases," PLOS Computational Biology, Public Library of Science, vol. 7(3), pages 1-13, March.
    13. Radhakrishnan Nagarajan & Marco Scutari, 2013. "Impact of Noise on Molecular Network Inference," PLOS ONE, Public Library of Science, vol. 8(12), pages 1-12, December.
    14. R Joseph Bender & Feilim Mac Gabhann, 2013. "Expression of VEGF and Semaphorin Genes Define Subgroups of Triple Negative Breast Cancer," PLOS ONE, Public Library of Science, vol. 8(5), pages 1-15, May.
    15. Deepak Poduval & Zuzana Sichmanova & Anne Hege Straume & Per Eystein Lønning & Stian Knappskog, 2020. "The novel microRNAs hsa-miR-nov7 and hsa-miR-nov3 are over-expressed in locally advanced breast cancer," PLOS ONE, Public Library of Science, vol. 15(4), pages 1-23, April.
    16. Khan Md Hasinur Rahaman & Bhadra Anamika & Howlader Tamanna, 2019. "Stability selection for lasso, ridge and elastic net implemented with AFT models," Statistical Applications in Genetics and Molecular Biology, De Gruyter, vol. 18(5), pages 1-14, October.
    17. Zhang, Shucong & Zhou, Yong, 2018. "Variable screening for ultrahigh dimensional heterogeneous data via conditional quantile correlations," Journal of Multivariate Analysis, Elsevier, vol. 165(C), pages 1-13.
    18. Zhiguang Huo & Li Zhu & Tianzhou Ma & Hongcheng Liu & Song Han & Daiqing Liao & Jinying Zhao & George Tseng, 2020. "Two-Way Horizontal and Vertical Omics Integration for Disease Subtype Discovery," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 12(1), pages 1-22, April.
    19. Cipolli III, William & Hanson, Timothy & McLain, Alexander C., 2016. "Bayesian nonparametric multiple testing," Computational Statistics & Data Analysis, Elsevier, vol. 101(C), pages 64-79.
    20. Markus Ringnér & Erik Fredlund & Jari Häkkinen & Åke Borg & Johan Staaf, 2011. "GOBO: Gene Expression-Based Outcome for Breast Cancer Online," PLOS ONE, Public Library of Science, vol. 6(3), pages 1-11, March.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:304:y:2022:i:c:s0277953619302862. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.