Many companies offer direct-to-consumer genetic testing. These tests give people access to their genetic information without involving a healthcare provider or health insurance company. The results may encourage consumers to make better lifestyles choices.
Direct-to-consumer genetic tests are marketed to customers via various media outlets and tests can be bought either online or in stores. Customers send a DNA sample and receive their results directly from either a secure website or in a written report. The most popular tests give information about health, disease risk or clues on ancestry.
These test kits could fall under the In Vitro Diagnostic Regulations depending on the product claims made by the manufacturer, who should define whether these are consumer products or for medical use.
Opportunities in this rapidly expanding market
The direct-to-consumer genetic testing market is increasing globally at a considerable rate, along with the range of health conditions and traits covered by these tests.
The number of people who had their DNA analyzed by direct-to-consumer genetic testing companies more than doubled in 2017, and now exceeds 12 million according to industry estimates . A recent study revealed genealogy is now the second most popular hobby in the United States and the second most popular internet-surfing topic .
An explanation for this upsurge could lie in the rise of personal awareness around health, the emerging culture of consumer empowerment and the demand for personalized consumer services.
There are many positives for carrying out these tests, for example:
• Costs of testing are known upfront • Sample collecting is usually easy and non-invasive • The results may be useful for future family planning • Results could help future genetic research
Challenges for consumer genomics
High consumer demand and interest in direct-to-consumer genetic tests have put more pressure on this market to deliver an optimum service.
As with other direct-to-consumer services, users are seeking quality assurance and clear information about the processes involved with this type of testing. Consumers are increasingly looking for more information, including:
• Does the company have experienced geneticists on its staff? • Does it include scientific evidence to link any variations with a particular disease or trait? • How is consumer privacy protected?
Direct-to-consumer genetic companies are being driven to deliver more analytical validity, produce results that can be interpreted clearly and offer consumers the option to get more details after receiving their test results.
Providing the best available practice
With this growing popularity for direct-to-consumer genetic testing, it's key that geneticists strive to build consumer trust and maximize customer satisfaction to develop a creditable service.
BSI is a recognized facilitator for industry best practice. We develop PASs with organizations for products, services and processes, and allow exploration of next practices. A PAS sets the standard for an industry by providing a framework to work more responsibly and better meet the needs of customers. Organizations have their profiles raised and their brands respected.
Developing a PAS for direct-to-consumer genetic testing would set the bar for good practice and potentially transform the way direct-to-consumer genetic testing is currently offered and managed.
We can develop best practice for non-regulatory aspects of these test kits. Our service means standards can adapt more quickly to define ‘state of the art’ for new products and guide manufacturers through best practice.
 REGALADO, ANTONIO. 2017 was the year consumer DNA testing blew up. MIT TECHNOLOGY REVIEW, 2017. Available from: http//www.technologyreview.com/s/610233/2017 [viewed January 2020].
 BOWEN, SCOTT, KHOURY, MUIN. Consumer genetic testing is booming: but what are the benefits and harms to individuals and populations. CDC 2018. Available from: http://www.blogs.cdc.gov/genomics/2018/06/12/consumer-genetic-testing/ [viewed January 2020].