23andMe passes two million milestone and gets FDA approval to offer health reports to US customers

While I was away last week in Birmingham at Who Do You Think You Are? Live it was announced that 23andMe have now obtained approval from the Food and Drug Administration (FDA) to offer genetic health reports on ten medical conditions, including Alzheimer's and Parkinson's, to their customers in the US. This is a landmark decision and clears the way for 23andMe to submit further applications in the future for additional reports. The approval will now put 23andMe in a very strong position as they are the only company who can say that their reports are approved by the FDA.

The new FDA reports will only be made available to 23andMe customers in the US, all of whom have now been migrated to the new 23andMe platform. 23andMe reintroduced their health reports in the UK back in 2014 but they haven’t updated any of the literature on most of these reports since about 2011 so they are now very out of date. 23andMe's customers in the UK, Canada and a few other countries are still in limbo on the old 23andMe platform. No announcement has been made about the availability of the reports in other countries. I assume that we will not be able to benefit from the updated reports until we have been migrated to the new website. There are rumours that we will be transitioned by the end of June, but it remains to be seen if this will happen.

It is also worth noting that there are still many health reports available to UK customers that have yet to be approved by the FDA in the US. One example is the report on the BRCA markers associated with hereditary breast and ovarian cancer. As this test is potentially diagnostic I understand it will have to go through a separate approval process.

There is no mention of 23andMe re-introducing the pharmacogenetic reports in the US. In a recent preprint Lu, Lewis and Traylor (2017) expressed concerns about the out-of-date pharmacogenetic reports that 23andMe are providing to their UK customers. The authors say:

Better mechanisms should be in place to ensure that tests reflect the latest science, to ensure tests do not become outdated. Pharmacogenetic research can move quickly – and producing out-of-date reports raises ethical questions since reports may be invalid based on updated research results.

It seems unlikely that 23andMe would be in a position to update these reports until they have approval from the FDA so I hope that they will eventually get clearance for these too.

Anne Wojcicki, the co-founder and CEO of 23andMe, was interviewed by Bloomberg on Friday and provided some interesting insights into the approval process and the company's future plans. She also revealed that the company now have over two million people in their database. 23andMe were reported to have 1.2 million customers in March 2016 which means that they have sold around 800,000 tests in the last 12 months or so.

Update 17th April 2017
The full text of the letter received by 23andMe from the FDA can be seen here. The official press release from the FDA can be seen here.

Update 22nd April
Note that US customers who tested prior to 23rd November 2013 will not have access to the new reports. See the article in the 23andMe help centre Am I eligible to receive the new Genetic Health Risk reports?

Further reading
I've provided links below to some of the most useful articles and blog posts about the FDA's approval of the 23andMe health reports:

• 23andMe rides again: FDA clears genetic test to predict disease risk by Matthew Herper. Forbes Magazine, 6 April 2017. This article also mentions the growth of the 23andMe database to 2 million.
• Good news about health reports, 23andMe Blog, 6 April 2017
• No doctor required: 23andMe cleared by FDA for at-home DNA tests by Alessandra Potenza, The Verge, 6 April 2017
• FDA approves sale of genetic tests for risk of Alzheimer’s and other diseases by Meghana Keshavan, Stat News, 6 April 2017.
• FDA approves 23andMe’s genetic test for personal disease risks by Thomas M Burton, Wall Street Journal, 6 April 2017
• 23andMe given green light to sell DNA tests for 10 diseases by Amy Maxman, Nature News and Comment, 6 April 2017
• FDA opens genetic floodgates with 23andMe decision by Emily Mullin, MIT Technology Review, 6 April 2017
• What a saliva kit can and can't tell you about your risk of Alzheimer's, Parkinson's or other diseases by Paul Sisson, San Diego Union-Tribune, 7 April 2017 
• Before you send your spit to 23andMe, what you need to know by Sharon Begley, Stat News, 7 April 2017.