Monday, January 20, 2014

The next controversy in genetic testing: clinical data as trade secrets?

 2013 Jun;21(6):585-8. doi: 10.1038/ejhg.2012.217. Epub 2012 Nov 14.

The next controversy in genetic testing: clinical data as trade secrets?

Author information

  • Institute for Genome Sciences & Policy and Sanford School of Public Policy, Duke University, Durham, NC, USA. gelp@duke.edu

Abstract

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 laboratoryservices; 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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