You may be surprised to learn that the government agency most responsible for "regulating" genetic testing is the FTC--the Federal Trade Commission. This group regulates advertising. If a company claims to do something they do not do, the FTC can intervene. However, the FTC has little control over the Internet and--contrary to its normal influence on other advertising--does not link with the FDA (Food and Drug Administration) to require that advertisers send out "Dear Doctor letters" to correct false advertising that appears on television or in print.
What controls are there?
The FDA, which oversees prescription and generic drugs as well as foods, does not review and approve genetic tests unless they are true medical devices--something that either must be provided by a physician (such as a heart pump) or directly diagnoses a condition (such as home HIV testing). The FDA considers most genetic testing "home brew". The FDA's extent of involvement then becomes the same as its involvement in any food or drug--no applications and approvals, but the FDA can insist that a product be removed from store shelves (e.g., ephedra) if it is shown to potentially cause harm. Psychological harm from false advertising is not included.
DNA tests and genetic tests, by the way, are considered "nonmedical tests", meaning that the results do not indicate a clinical condition that can be dealt with in a physician's office or hospital. Medical tests include blood cell counts, chemistry analysis, urinalysis, tissue examination. Newborn genetic testing is medical testing, since the tests look for the accumulation of specific substances in the blood. DNA testing (forensic, paternity, genealogical) and genetic testing for specific genes and/or mutations are nonmedical tests.
The most strict oversight of genetic testing laboratories comes from organizations that accredit and approve laboratories. Among these are the AABB (American Association of Blood Banks), CAP (College of American Pathologists), CLIA (Clinical Laboratory Improvement Amendments and CLIAC, Clinical Laboratory Improvement Amendments Committee), and ISO (International Organisation for Standards, specifically ISO 17025 for laboratories). All of these organizations offer voluntary accreditations for testing laboratories; only AABB specifically identifies accreditation for DNA testing (but not other genetic testing). The following URLs get you to the home page of these organizations:
http://www.aabb.org/Content/Accreditation/Parentage_Testing_Accreditation_Program/ptprog.htm
http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=accreditation
http://www.phppo.cdc.gov/clia/default.aspx
http://www.qualico.co.uk/html/iso_17025_lab_requirements.html
None of these organizations has any regulatory clout; they can only refuse or revoke accreditation. The closest to regulatory clout is the CDC (Centers for Disease Control), a federal agency that is primarily concerned with the spread of infectious diseases (influenza, sexually-transmitted, food poisoning).
Some states require that forensic or parental DNA testing be conducted by specific laboratories for the results to be considered acceptable in legal cases.
The Genetic Alliance, a group coordinating the activities of hundreds of support groups for specific genetic conditions, recently requested that standards for genetic testing be set and enforced by CMS (Centers for Medicare and Medicaid Services).
If you're thinking of DNA or genetic testing, check whether the company you are considering advertises accreditation by one or more of these organizations. Then--if you can--check to see whether the accreditation is current. This is possible for AABB by going to http://www.aabb.org/Content/Accreditation/Parentage_Testing_Accreditation_Program/AABB_Accredited_Parentage_Testing_Laboratories/ . None of the other organizations provide similar lists, but you can ask the company you are interested in by calling their toll-free number.
Whatever you do, remember the old adage: Buyer beware!
Marie Godfrey, PhD