TY - JOUR
T1 - The next controversy in genetic testing
T2 - Clinical data as trade secrets?
AU - Cook-Deegan, Robert
AU - Conley, John M.
AU - Evans, James P.
AU - Vorhaus, Daniel
N1 - Funding Information:
This work was supported in part by NIH grant P50 HG003391, the Ewing Marion Kauffman Foundation and Fondation Brocher. This manuscript benefited from the insightful comments of Richard Epstein, Michael Hopkins, Patrick Willems and anonymous reviewers. Author contributions: All four authors were directly involved in all phases of writing and revising this manuscript.
Publisher Copyright:
© 2013 Macmillan Publishers Limited.
PY - 2013/6/1
Y1 - 2013/6/1
N2 - Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing - and compelling participation in - resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.
AB - Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing - and compelling participation in - resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.
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U2 - 10.1038/ejhg.2012.217
DO - 10.1038/ejhg.2012.217
M3 - Article
C2 - 23150081
AN - SCOPUS:84883100680
SN - 1018-4813
VL - 21
SP - 585
EP - 588
JO - European Journal of Human Genetics
JF - European Journal of Human Genetics
IS - 6
ER -