TY - JOUR

T1 - Walking the tightrope

T2 - expectations and standards in personal genomics

AU - Groves, Christopher

AU - Tutton, Richard

PY - 2013/6/1

Y1 - 2013/6/1

N2 - The sociology of expectations has examined ways in which future expectations shape how technological options are selected and stabilised. Personal genomic susceptibility testing (PGST) is introduced as an example of a technology where expectations serve a crucial role, thanks to the inherently future-oriented nature of testing for genetic susceptibility to future health conditions. Nonetheless, expectations may increase rather than decrease scientific, regulatory and commercial uncertainties surrounding a technology. Technology promoters may therefore enact particular strategies to prove that technologies are not in need of stringent, technology-specific regulation. With the aid of an extensive historical analysis of company websites, together with semi-structured interviews with company representatives, it is shown how four PGST companies based in the United States have used efforts towards collaborative standardisation as ways of stabilising and legitimating PGST in an often hostile environment. We explore how these strategies make use of expectations, and how they centre on the promotion of new ‘regulatory objects’ in an effort to influence regulatory agendas. Although processes of standardisation in the PGST industry have stalled, we suggest that they nonetheless represent successful engagement with regulators, insofar as they have succeeded in shaping regulatory agendas and staving off new regulation.

AB - The sociology of expectations has examined ways in which future expectations shape how technological options are selected and stabilised. Personal genomic susceptibility testing (PGST) is introduced as an example of a technology where expectations serve a crucial role, thanks to the inherently future-oriented nature of testing for genetic susceptibility to future health conditions. Nonetheless, expectations may increase rather than decrease scientific, regulatory and commercial uncertainties surrounding a technology. Technology promoters may therefore enact particular strategies to prove that technologies are not in need of stringent, technology-specific regulation. With the aid of an extensive historical analysis of company websites, together with semi-structured interviews with company representatives, it is shown how four PGST companies based in the United States have used efforts towards collaborative standardisation as ways of stabilising and legitimating PGST in an often hostile environment. We explore how these strategies make use of expectations, and how they centre on the promotion of new ‘regulatory objects’ in an effort to influence regulatory agendas. Although processes of standardisation in the PGST industry have stalled, we suggest that they nonetheless represent successful engagement with regulators, insofar as they have succeeded in shaping regulatory agendas and staving off new regulation.

KW - direct-to-consumer genetic testing

KW - personal genomics

KW - personalised medicine

KW - regulation

KW - sociology of expectations

KW - standardisation

U2 - 10.1057/biosoc.2013.1

DO - 10.1057/biosoc.2013.1

M3 - Journal article

VL - 8

SP - 181

EP - 204

JO - BioSocieties

JF - BioSocieties

SN - 1745-8552

IS - 2

ER -