PHG Foundation | 23andMe engages with the FDA on health-related genetic tests

PHG Foundation | 23andMe engages with the FDA on health-related genetic tests

Philippa leads our communications and knowledge management activities, including dissemination of the PHG Foundation’s activities and outputs.

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Personal genomics provider 23andMe may have taken the first steps towards gaining regulatory approval for their health-related products from the Food and Drug Administration (FDA).

Last November, 23andMe was warned to cease sales of direct-to-consumer genetic risk testing by the US regulator after protracted non-compliance with the stipulated regulatory requirements. Now it seems that the giant of genetic testing must have been working to produce the sort of information that the FDA requires, as they haveannounced that the FDA has accepted an application for a single ‘health report’. 

This report is for a rare inherited condition called Bloom syndrome, and is said to contain validation data including the sample collection (saliva) kit, the microchip used for the genotyping test itself, and the associated computer software, as well as the accuracy of testing.

The FDA will now review the application and may have further questions for 23andMe; Chief Legal and Regulatory Officer Kathy Hibbs nevertheless describes it as ‘an important step in our work with the FDA in the coming months’, apparently as a sort of test run to ‘establish the parameters for future submissions’.

23andMe publicly acknowledge that they are only at ‘very early stages of this regulatory review process’ and are careful to note that further steps may be needed to secure approval even for this single isolated example, whilst stressing that they are ‘moving forward’. This could take a long time, since the original Personal Genome Service involved testing for genetic variants associated with 254 different conditions.

The fact that the company has been busily appointing new expertsincluding Kathy Hibbs suggests that satisfying the FDA and resuming sales of health-related (as opposed to merely genealogical) information is essential for their survival. However, with the cessation of Personal Genome Service sales clearly set to extend well beyond the current seven-month period, the financial impact of failing to meet regulatory requirements much earlier on in the development of the company must be severe.

23andMe was founded by Anne Wojcicki, married to (but separated from) Google co-founder Sergey Brin, and is backed by Google itself; with less powerful backers it seems likely that the company would have folded by now, especially since providing the validation data demanded by the FDA was clearly not a simple box-ticking exercise. The FDA’s concerns were apparently entirely justified. However, as well as moving ahead with efforts to create an FDA-compliant product, it is said to be exploring additional international market opportunities in Canada, Australia and the UK.