TY - JOUR
T1 - Direct-to-consumer testing
T2 - More risks than opportunities
AU - Lippi, G
AU - Favaloro, E J
AU - Plebani, M
N1 - © 2011 Blackwell Publishing Ltd.
Includes bibliographical references
PY - 2011/12
Y1 - 2011/12
N2 - As a result of incessant genetic discoveries and remarkable technological advancements, the availability and the consequent consumer's request for genetic testing are growing exponentially, leading to the development of a 'parallel' market, i.e. the direct-to-consumer (DTC) testing, also known as 'direct access testing' (DAT). Analogous to the traditional laboratory diagnostics, drawbacks of DTC testing might arise from any step characterising the total testing process, and include poor control of both appropriateness and preanalytical requirements, potential operation outside national or international regulation for in vitro diagnostic testing, little evidence of quality as well as the risk of transfer of genetic materials from the companies to other entities. Another important issue is the test panels offered to consumers, which are often based on preliminary, speculative or unsupported scientific information. Finally, the potential of this type of testing to generate anxiety or false reassurance should also be carefully considered. Although DTC testing carries some theoretical advantages (e.g. greater consumer autonomy and empowerment), solid clinical studies and costs vs. benefit analyses are needed to definitely establish whether DTC testing might be effective for decreasing the burden of diseases, delay their onset or modify their progression and therefore the clinical outcome.
AB - As a result of incessant genetic discoveries and remarkable technological advancements, the availability and the consequent consumer's request for genetic testing are growing exponentially, leading to the development of a 'parallel' market, i.e. the direct-to-consumer (DTC) testing, also known as 'direct access testing' (DAT). Analogous to the traditional laboratory diagnostics, drawbacks of DTC testing might arise from any step characterising the total testing process, and include poor control of both appropriateness and preanalytical requirements, potential operation outside national or international regulation for in vitro diagnostic testing, little evidence of quality as well as the risk of transfer of genetic materials from the companies to other entities. Another important issue is the test panels offered to consumers, which are often based on preliminary, speculative or unsupported scientific information. Finally, the potential of this type of testing to generate anxiety or false reassurance should also be carefully considered. Although DTC testing carries some theoretical advantages (e.g. greater consumer autonomy and empowerment), solid clinical studies and costs vs. benefit analyses are needed to definitely establish whether DTC testing might be effective for decreasing the burden of diseases, delay their onset or modify their progression and therefore the clinical outcome.
KW - Access to Information
KW - Commerce
KW - Genetic Markers
KW - Genetic Testing/methods
KW - Humans
KW - Marketing of Health Services/organization & administration
KW - Patient Acceptance of Health Care
KW - Patient Identification Systems/standards
KW - Quality Control
KW - Research Design
KW - Specimen Handling/standards
KW - Thrombophilia/genetics
U2 - 10.1111/j.1742-1241.2011.02774.x
DO - 10.1111/j.1742-1241.2011.02774.x
M3 - Review article
C2 - 22093530
SN - 1368-5031
VL - 65
SP - 1221
EP - 1229
JO - International Journal of Clinical Practice
JF - International Journal of Clinical Practice
IS - 12
ER -