In 2013, the FDA sent "cease and desist" letters to several DTC genetic testing companies, ordering them to immediately discontinue marketing and sales of their health-related testing services until they received FDA authorization for these devices. In 2015, the FDA allowed DTC testing services to apply for medical device approval, opening the door for companies to provide genetic health risk screens and carrier screens that have been approved by the FDA. The FDA has granted permission for DTC testing to detect genetic variants associated with medication metabolism, genetic health risk tests, and carrier screens.¹

DTC companies are permitted to use consumer genetic information (de-identified, aggregate) for profit in research. They must obtain the consumer's informed consent before using their data.²

A prescription written by an ordering physician is only sometimes required for DTC genetic testing. While some tests may require a prescription, others can be ordered directly by consumers without a physician's involvement.^3,4

FDA granted clearance for pharmacogenomic testing in 2020, but the results are not intended to be used to make medical decisions without confirmatory testing (except for clopidogrel and citalopram). Health care professionals should caution their patients not to use DTC pharmacogenomic results to modify or discontinue medications on their own.¹

References:
1. National Human Genome Research Institute (NHGRI). Direct-to-Consumer Genetic Testing FAQ. NHGRI website. Updated March 31, 2022. Accessed May 22, 2023. https://www.genome.gov/For-Health-Professionals/Provider-Genomics-Education-Resources/Healthcare-Provider-Direct-to-Consumer-Genetic-Testing-FAQ.
2. 23andMe. 23andMe Research Innovation Collaborations Program. 23andMe website. (n.d.). https://research.23andme.com/research-innovation-collaborations/.
3. Allyse MA et al. Mayo Clin Proc. 2018;93:113-120.
4. Majumder MA et al. Annu Rev Med. 2021;72:151-166.