Types of dtc genetic tests on the market

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A growing number of commercial firms are advertising and selling genetic tests directly to consumers. A February 2008 article in Nature Biotechnology observes:

The onset of genetic testing as a wide-spread consumer commodity continues to gather pace. At least 27 web-based companies now offer genetic tests - once the exclusive domain of hospital clinics and academic laboratories - directly to consumers for costs ranging from roughly $100 for a simple gene scan to $350000 for a personal genome sequence and related medical advice (Schmidt, 2008).

In a December 2007 report, the UK Human Genetics Commission (2007, Appendix 2) identified 26 companies based in the USA, UK and Europe that advertise and/or sell DTC genetic tests. While not an exhaustive count of the number of firms currently operating in this field, the tests provided by these 26 companies reveal the range of health concerns for which testing is available and the variable models by which services are offered. DTC tests assess genetic predisposition for a range of diseases and conditions, including cancer (mainly breast, ovarian, prostate and colorectal cancer), cardiovascular disease, osteoporosis, diabetes (type 1 and type 2), obesity, celiac disease, inflammatory bowel disease, hemochromato-sis, factor V Leiden, thrombophilia, glaucoma, macular degeneration and Alzheimer's disease. They may test for genetic factors that affect lipid, glucose, caffeine, alcohol and pharmaceutical metabolism. Pregnancy and newborn screening tests are also available. Some tests are bundled into packages marketed to men (e.g. including tests for genetic predisposition for prostate cancer and cardiovascular disease) and women (e.g. including tests for genetic predisposition to breast cancer and osteoporosis). A nutrigenetic test package may test for various genes that affect nutrient metabolism and susceptibility to common diseases that may be mitigated through dietary changes. Some tests aimed at fitness enthusiasts or athletes offer information to help optimize physical training and nutrition to enhance performance.

Genetic tests that are sold DTC require a consumer to order the company's test kit, collect a genetic sample at home (generally a buccal swab), return it to the company for analysis and, for some tests, provide lifestyle information, including information about sex, age, health history, diet and other behaviors (e.g. tobacco use, exercise). Exchange of personal information and test results may be done online or by mail and counseling, where provided, may be done by telephone or by referral to in-person counseling. Business models vary among genetic testing companies. Some provide only one or a few types of tests, while others offer a broader range. Some sell tests directly to consumers, while others simply advertise DTC but only accept testing referrals from a health care professional (typically a physician). Some provide post-test counseling with a health care professional (such as a dietician, genetic counselor or physician) to explain test results and discuss potential lifestyle modifications or need for medical follow-up. If counseling is offered, it may be included in a standard fee or it may be an optional service available at extra cost. In addition to genetic testing services, some companies sell nutritional supplements claimed to be formulated to improve heart health, bone health or other problem areas identified through the company's genetic testing. In some cases, companies market packages that include genetic testing, consultation and, sometimes, diet plans and supplements, aimed at mitigating disease susceptibility or achieving weight loss.

In an analysis of 24 DTC genetic testing companies, Geransar and Einsiedel (2008) examined the companies' target markets (tests marketed to consumers only or health professionals and consumers both), company policies regarding involvement of physicians in the testing process (the consumer's physician or a physician associated with the company, or no involvement) and company policies regarding genetic counseling (counseling in person, via telephone or other means, consumer's physician responsible for referral to genetic counselor, referral to contracted counselor, or no requirement for genetic counseling). They also examined the types of information on company websites about the genetic condition(s) for which tests are sold (e.g. information about disease symptoms, prevention, treatment) and cited sources of information (e.g. peer-reviewed studies, unpublished company studies, professional organizations). Companies that sell nutrigenetic tests were less likely to require physician involvement (compared, for example, to companies that sell diagnostic or predisposition tests for conditions like cystic fibrosis, Huntington disease, Alzheimer's disease and breast and ovarian cancer) and to offer counseling by telephone or other long-distance means.

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