November 2010

The FDA versus Personal Genetics Firms

Personal GenomicsShortly after the meeting, the U.S. Congress also held a hearing with personal genetic firms that discussed “Direct-to-Consumer Genetic Testing and the Consequences to the Public Health.” In this meeting, the U.S. Government Accountability Office (GAO) presented evidence from a year-long undercover investigation of several personal genomics companies. The GAO suggested the tests were “misleading and of no practical use,” pointing out that identical samples from one individual produced varied, and often conflicting, results across the four companies investigated. Claims ranged from blatant disregard for consumer consent, to lack of utility of the tests to deceptive marketing tactics.

The actual fallout of these meetings has not yet been fully articulated. What is definitive is that federal regulation is looming over the DTC genetic testing industry and that it will be designed to ensure that consumers are protected. This likely will include regulation that ensures validity, accuracy and utility of the genetic tests; consumer consent; consumer privacy and involvement of health care providers.

For Better or for Worse?

With the promise of premarket clearance of DTC genetic tests on the horizon comes the question of whether such guidelines ultimately will hamper the advances this industry promises. In the face of regulation, Pathway Genomics’ partnership with Walgreens practically has dissolved. Both Pathway and Navigenics now require consumers to sign up through either their “physician or corporate wellness program.” DeCODeme currently is not offering tests online that scan for cancer and cardiovascular conditions. Other firms might opt to move their businesses elsewhere, outside the borders of this country and federal regulation. As of 2007, 13 states prohibited direct-to-consumer genetic tests, whereas 25 states, plus the District of Columbia, permitted it. In light of everything that has occurred, it will be interesting to see how federal oversight ultimately will impact this industry.

Lola Olufemi ( is a doctoral candidate/NSF BRIDGE fellow at the Southern Illinois University School of Medicine.


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