Where is the consumer genetic testing industry headed?
Giving consumers clarity and choice
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.
Sources
[1] 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].
[2] 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].