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.
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 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
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 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.
To learn about quality regulations within clinical laboratories, click here.
With this growing popularity of 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 healthcare best practices. Our management system standards, such as BS EN ISO/IEC 27001 Information security management system (ISMS) and BS EN ISO 9001 Quality management system can help direct-to-consumer genetic organizations build trust with their customers, become reputable brands, and overcome some of the above challenges within the industry currently.
BS EN ISO 9001 is the internationally recognized Quality Management System (QMS) standard that can benefit any size organization. Designed to be a powerful business improvement tool, BS EN ISO 9001 implementation can help you to:
Continually improve, streamline operations and reduce costs
Win more business and compete in tenders
Satisfy more customers
Be more resilient and build a sustainable business
Show you have strong corporate governance
Work effectively with stakeholders and your supply chain
As direct-to-consumer genetic organizations handle a lot of personal information, they simply can’t be too careful when it comes to information security. Protecting personal records and commercially sensitive information is critical. BS EN ISO/IEC 27001 helps you implement a robust approach to managing information security (infosec) and building resilience.
As innovations continue to disrupt the healthcare sector, accessing the standards your business needs to adapt to these emerging ways of working does not have to be complicated and time-consuming. Our tailored BSI Knowledge subscription service provides flexibility, access, visibility, and control over the standards and insights your team needs to adopt emerging processes. Request to learn more.
Improve the practices of your direct-to-consumer genetic business by adding these healthcare standards to your collection today.