On Wednesday, the House Committee on Energy and Commerce announced that it and the Subcommittee on Oversight and Investigations have begun investigating personal genetic testing kits being sold over the internet. Chair Henry A. Waxman (D-CA), Ranking Member Joe Barton (R-TX), Subcommittee Chairman Bart Stupak (D-MI), and Subcommittee Ranking Member Michael C. Burgess (R-TX) have sent letters to companies 23andMe, Inc., Navigenics, and Pathway Genomics Corporation after reports surfaced in the New York Times that one of the companies (Pathway) may be planning to sell personal genetic testing kits in retail locations. The committee says that the scientific community has concerns regarding the accuracy of the tests.

The letters to the companies request that they produce the following information for the Committee by June 4:

--A chart listing the conditions, diseases, consumer drug responses, and adverse reactions for which the companies test;
--All materials regarding genetic counseling and physician consultations, including documents regarding what conditions, diseases, drug responses, or adverse reactions trigger the need for genetic counseling or physician consultation, and documents concerning communications with consumers regarding individual genetic testing results;

--All documents relating to the ability of the genetic testing products to accurately identify consumer risk, including: internal and external communications regarding the accuracy of the testing; documents describing how analysis of individual test results controls for scientific factors such as age, race, gender, and geographic location; third party communications validating the association between the scientific data the company uses for analyzing test results and the consumer's risk for each condition, disease, drug response, or adverse reaction as identified by the results of an individual test; and documents relating to proficiency testing conducted by the companies' clinical laboratories;

--All documents regarding policies for processing and use of individual DNA samples collected from consumers, including those regarding collection, storage, and processing of individual DNA samples; protection of consumer privacy; and regarding collected DNA sample uses other than to provide individual genetic counseling to a consumer;

--All documents regarding compliance with the Federal Food, Drug, and Cosmetic Act and U.S. Food and Drug Administration regulations.

The Committee announcement and letters to the companies may be found at:
http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2009:committee-investigates-personal-genetic-testing-kits&catid=122:media-advisories&Itemid=55

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