San Francisco Chronicle Examines Field Of Direct-To-Consumer Genetic Testing

Main Category: Genetics
Also Included In: Women's Health / Gynecology;  Pregnancy / Obstetrics
Article Date: 29 Aug 2007 - 15:00 PST

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The San Francisco Chronicle on Tuesday examined the new field of direct-to-consumer genetic testing, including home-based paternity tests and tests that can determine the gender of a fetus. A paternity test released last week by Sunnyvale, Calif.-based Consumer Genetics can be done without the man's knowledge. In addition, more companies also are offering home tests that can indicate a person's risk for diseases 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 and medical professionals also have voiced concerns about how patients might react to "undesirable results" at home or whether pregnant women would 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 test designed to identify gender as early as six weeks, is facing a class action lawsuit for allegedly providing inaccurate gender results. More than 100 women nationwide are suing the company for causing distress from inaccurate results. Sens. Edward Kennedy (D-Mass.) and Gordon Smith (R-Ore.) earlier this year introduced legislation that would require makers of direct-to-consumer genetic tests to prove to FDA that their tests are accurate and properly carried out.

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"Right now, we don't have anyone minding the store," Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, said, adding, "Without appropriate safety and quality assurances and without consumer protections being in place, individual consumers don't have access to information about the quality of the laboratories or the validity of claims made about a specific test." Jesse Reynolds -- policy analyst at the Oakland, Calif.-based Center for Genetics and Society -- said, "The upside of [the tests] is that the individual is empowered. But, at the same time, that can be ... challenging, particularly when what's at stake is powerful information such as possession 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 serious illnesses -- said her company tries to distinguish DNA Direct from other companies by using federally certified labs, licensed genetic counselors and a report written for consumers. "We try to help consumers understand genes are not destiny, but they provide valuable information," Phelan said (Colliver, San Francisco Chronicle, 8/21).

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