Abstract
The Internet currently enables unprecedented ease of access for direct-to-consumer (DTC) genetic testing, with saliva collection kits posted directly to consumer homes from anywhere in the world. This poses new challenges for local jurisdictions in regulating genetic testing, traditionally a tightly-regulated industry. Some Internet-based genetic tests have the capacity to cause significant confusion or harm to consumers who are unaware of the risks or potential variability in quality. The emergence of some online products of questionable content, unsupported by adequate scientific evidence, is a cause for concern. Proliferation of such products in the absence of regulation has the potential to damage public trust in accredited and established clinical genetic testing during a critical period of evidence generation for genomics. Here, we explore the challenges arising from the emergence of Internet-based DTC genetic testing. In particular, there are challenges in regulating unaccredited or potentially harmful Internet-based DTC genetic testing products. In Australia, challenges exist for the Therapeutic Goods Administration, which oversees regulation of the genetic testing sector. Concerns and challenges faced in Australia are likely to reflect those of other comparable non-US jurisdictions. Here, we summarize current Australian regulation, highlight concerns, and offer recommendations on how Australia and other comparable jurisdictions might be more proactive in addressing this emerging public health issue.
Highlights
A direct-to-consumer (DTC) genetic test is any DNA test for a medical or non-medical trait that provides interpretation or communication of test results directly to a consumer, rather than via a health professional
DTC genetic tests are often accessed via the Internet without the need for a medical referral, outside of the health system
Internet-based DTC genetic tests vary in price, quality, and genetic content measured, ranging from “recreational” testing [1] to return of medical disease risk information [2]
Summary
A direct-to-consumer (DTC) genetic test is any DNA test for a medical or non-medical trait that provides interpretation or communication of test results directly to a consumer, rather than via a health professional. DTC genetic tests are often accessed via the Internet without the need for a medical referral, outside of the health system. Online DTC genetic tests are growing in popularity due to various consumer motivations, many of which are not necessarily medical in nature [2, 3]. Direct access via a global online marketplace creates challenges for non-US authorities in enforcing local regulations on Internet-based products. How local jurisdictions, such as Australia, the UK, and Europe, should approach regulation and quality control of Internet-based genetic testing is uncertain [9,10,11,12]. Many of these challenges are not necessarily unique to the field of genetic testing and have been mirrored in other regulated industries recently disrupted by the emergence of a global online marketplace, such as the online prescription drug sector [13]
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