San Francisco Chronicle Examines Direct-To-Consumer Genetic Testing

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Direct-To-Consumer Genetic Testing

The San Francisco Chronicleon Tuesday examined the new field of direct-to-consumer genetictesting, including home-based paternity tests and tests that candetermine the gender of a fetus. A paternity test released last week bySunnyvale, Calif.-based Consumer Geneticscan be done without the man's knowledge. In addition, more companiesalso are offering home tests that can indicate a person's risk fordiseases such as ovarian or breast cancer.

According to the Chronicle,consumer genetic testing might offer convenience and privacy, but it is"largely unregulated and quality may vary widely." Ethicists andmedical professionals also have voiced concerns about how patientsmight react to "undesirable results" at home or whether pregnant womenwould seek an abortion if the fetus is not the desired gender, the Chronicle reports.


In addition, some of the tests have led to legal action, according to the Chronicle.Massachusetts-based Acu-Gen Biolab, the maker of a genetic testdesigned to identify gender as early as six weeks, is facing a classaction lawsuit for allegedly providing inaccurate gender results. Morethan 100 women nationwide are suing the company for causing distressfrom inaccurate results. Sens. Edward Kennedy (D-Mass.) and GordonSmith (R-Ore.) earlier this year introduced legislation that wouldrequire makers of direct-to-consumer genetic tests to prove to FDA that their tests are accurate and properly carried out.


"Right now, we don't have anyone minding the store," Kathy Hudson, director of the Genetics and Public Policy Centerat Johns Hopkins University, said, adding, "Without appropriate safetyand quality assurances and without consumer protections being in place,individual consumers don't have access to information about the qualityof the laboratories or the validity of claims made about a specifictest." Jesse Reynolds -- policy analyst at the Oakland, Calif.-based Center for Genetics and Society-- said, "The upside of [the tests] is that the individual isempowered. But, at the same time, that can be ... challenging,particularly when what's at stake is powerful information such aspossession of a gene that's related to a fatal disease."

Ryan Phelan -- founder and CEO of San Francisco-based DNA Direct,which provides direct-to-consumer testing for a range of seriousillnesses -- said her company tries to distinguish DNA Direct fromother companies by using federally certified labs, licensed geneticcounselors and a report written for consumers. "We try to helpconsumers understand genes are not destiny, but they provide valuableinformation," Phelan said (Colliver, San Francisco Chronicle, 8/21).

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