Here’s a hypothetical scenario: someone uses a home DNA test and presents to their healthcare practitioner (HCP) with grave concerns because they are “at risk of developing” a whole host of diseases. The HCP sees more than one patient that day with similar concerns. Healthcare horror story or positive progression? Whatever your view, this could soon be a reality – at least in the UK. Earlier this month, the country’s Medicines and Healthcare Products Regulatory Agency (MHRA) agreed to allow California-based DNA service providers 23andMe to market its saliva collection kit and personal genome service (PGS). Interestingly, just over a year ago the FDA banned the company from promoting its service in the US. Why? According to the warning letter issued in November 2013 (1), 23andMe were doing so “without marketing clearance or approval” and the healthcare regulator did “not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses” despite numerous information requests. According to a spokesperson, however, those things that were a concern to the US watchdog have been removed from the CE marked test (2) and a subsequent letter to 23andMe confirmed the violations had been addressed (3).
However, cautions of the potential health consequences that could result from false-positive or -negative assessments remains, in particular for high-risk conditions, such as BRCA-related genetic risk and drug responses. Nevertheless, 23andMe CEO, Ann Wojcicki, believes providing information on 254 diseases and conditions (which includes categories such as carrier status, health risks, and drug response) to customers “is empowering” (2).
The company’s intended use of the data generated from these tests has also set alarm bells ringing for some. In fact, director of the Center for Law and the Biosciences at Stanford University in California went as far as to query if the firm’s long-term business plan was to make money by selling the data. Perhaps that’s not an entirely surprising accusation given 23andMe’s recent partnership with Google to supply genomic data for the tech giant’s latest endeavor: building a complete database of the human genome (4).
The actual impact that public availability of these tests will have on UK consumers, HCPs and pathology labs remains to be seen and I’d really like to hear your thoughts. Do you welcome these tests? Could they have a positive impact on your work or indeed the profile of your profession? Let us know by commenting on our website (www.thepathologist.com). For now, the MHRA, as well as the Department of Health and patient societies, like the Alzheimer’s Society, warn to approach them with caution.
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References
- FDA Warning Letter issued to 23andMe, Inc. (22 Nov 2013) http://1.usa.gov/1avFitx. M. Roberts, P. Rincon, “Controversial DNA Test Comes to UK,” BBC News (2 Dec 2014) http://bbc.in/1CARHQQ. FDA Close Out Letter issued to 23andMe, Inc. (25 Mar 2014) http://1.usa.gov/1ukDayG. M. Schubert, “The Google Genome,” The Pathologist, 2, 42–43 (2014).
