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Pink or Blue? The Need for Regulation is Black and White

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Publication Date: July 2006

Publisher(s): American Society for Reproductive Medicine

Author(s): Gail H. Javitt

Funder(s): Pew Charitable Trusts

Funder(s): Pew Charitable Trusts

Topic: Health (Licensing and regulation)
Health (Medical research and technology)

Keywords: Fetal gender; Regulation; Direct-to-consumer; Genetic testing

Type: Other

Coverage: United States


A new direct-to-consumer genetic test purports to detect fetal gender as early as five weeks of pregnancy. The availability of this test highlights the consequences of the current system of oversight for genetic tests and underscores the need for an enhanced regulatory framework to ensure the accuracy, reliability, and validity of genetic tests.

In Fertility and Sterility, vol.86:1, July 2006, p.13-15.