In recent years, there has been significant increase in the number of Direct-to-Consumer (DTC) genetic tests that consumers can purchase over the internet, without the involvement of a doctor. The National Health and Medical Research Council (NHMRC) recommends that consumers interested in purchasing DTC genetic tests should exercise caution and understand the important issues associated with DTC genetic testing.
What is a Direct-to-Consumer (DTC) genetic test?
Direct-to-Consumer genetic tests are purchased directly by consumers, often over the internet and without the involvement of a medical professional. A sample such as saliva or a swab from the inside of your mouth is sent to a laboratory where they analyse the sample and provide the results directly to the consumer. The results may be used to establish parentage or ancestry, or to indicate pre-disposition to a particular disease.
What should I consider if I am interested in a DTC genetic test?
There are important factors to consider if you are thinking about having a DTC genetic test, including that:
- Companies offering DTC genetic tests are mostly located overseas and may not meet the quality standards that apply in Australia;
- A person’s genes are not the only things that determine their future health, and the results of genetic tests need to be considered in the context of other factors such as lifestyle, environmental factors and normal ageing;
- Some DTC companies may sell information about you and your genetic results to pharmaceutical and other companies; and
- Obtaining your own genetic test results may reveal unexpected information about you and your blood relatives. This information may also have implications for obtaining risk-rated life insurance.
Genetic issues are complex, and DTC genetic tests should not be used as the sole basis for clinical decision making and health care. Anyone who has concerns about a genetic condition, or about their current or future health, should consult their doctor. In Australia, when genetic testing is suggested by a doctor, patients are referred to a clinical setting and provided with access to a broad range of professional advice, support and genetic counselling. This level of support and advice may not be available from a DTC genetic test provider.
What consumer protection is available when dealing with Australian and/or overseas DTC testing laboratories?
As DTC DNA testing is a relatively new and mostly unregulated industry, customers of these services should exercise caution in choosing a provider.
In Australia, laboratories wanting to offer DTC genetic tests must adhere to Australian regulatory requirements — for example, formal accreditation undertaken through the National Australian Testing Authority (NATA). If the laboratory offering the DNA test is located overseas, it may be difficult to determine the type of accreditation obtained by that laboratory, or how well the laboratory will perform the DNA test.
Disclaimers attached to the testing may clear the DTC genetic testing company of any responsibility if an inaccurate or incorrectly interpreted test result is provided to the consumer. The degree of consumer protection is even more difficult to determine where DTC genetic tests are offered by overseas laboratories.
Although Australian law protects a consumer’s privacy rights where services are provided in Australia, these protections do not apply outside of Australia. It is difficult to determine how well privacy is safeguarded by DTC DNA laboratories outside of Australia.
- Direct-to-Consumer Genetic Testing: A Statement from the National Health and Medical Research Council (NHMRC)
- Discussing Direct-to-Consumer Genetic DNA Testing with Patients: A Short Guide for Health Professionals
- Understanding Direct-to-Consumer Genetic DNA Testing – An Information Resource for Consumers
Page last updated on 10 December 2014