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Direct-to-Consumer Genetic Testing: Gatekeeping the Production of Genetic Information


Gaia Bernstein


Seton Hall University - School of Law

February 22, 2011

University of Missouri-Kansas City Law Review, Vol. 79, No. 2, p. 283, 2010
Seton Hall Public Law Research Paper No. 1767383

Abstract:     
Traditionally, the practice of genetic testing was governed by the Diagnostic Paradigm. Under the Diagnostic Paradigm an individual tested for a disease that was prevalent in his family and a medical professional guided the testing process. Yet, recently, a new genetic testing paradigm has emerged - the Consumer Paradigm. Under the Consumer Paradigm, direct-to-consumer genetic testing companies are offering online packages of multiple genetic tests that are bundled together. The individual purchases the package and undergoes testing for a large battery of tests usually without the guidance of a medical practitioner.

This Essay argues that the emergence of the Consumer Paradigm signals a new step in the genetic revolution and creates a need for an additional policy focus. While in the past legal discourse focused on the removal of barriers for innovation and access, it should now also consider the need to regulate and filter the production of genetic information. Specifically, this Essay underscores the necessity of having a medical professional as a gatekeeper of the production of genetic information.

This Essay argues for the need for a law mandating the guidance of a medical professional not only at the interpretation stage but also at the outset of the process - to guide individuals through the selection of tests. Not all genetic information is made equal and not all test results are similarly desirable for all people. A medical practitioner can guide individuals in selecting the genetic tests that reflect their preferences and produce the genetic information that is beneficial for them.

Number of Pages in PDF File: 12

Keywords: genetic testing. direct to consumer, internet, physicians, genetic counselors, FDA

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Date posted: February 23, 2011 ; Last revised: July 28, 2013

Suggested Citation

Bernstein, Gaia, Direct-to-Consumer Genetic Testing: Gatekeeping the Production of Genetic Information (February 22, 2011). University of Missouri-Kansas City Law Review, Vol. 79, No. 2, p. 283, 2010; Seton Hall Public Law Research Paper No. 1767383. Available at SSRN: http://ssrn.com/abstract=1767383

Contact Information

Gaia Bernstein (Contact Author)
Seton Hall University - School of Law ( email )
One Newark Center
Newark, NJ 07102
United States
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