Genetic Testing Mix-up at 23andMe, Another Blow to the Industry


23andMe may have provided the wrong results to as many as 96 customers for its genetic testing services. According to statements made on the 23andMe blog, human error was behind the mistake at LabCorp which provides the Silicon Valley company with its genetic processing. A single 96-well plate used in processing samples was incorrectly placed. Comments accessible only to 23andMe customers reveal that the mix-up caused serious distress among some of those affected (as reported in Genetic Futures and New Scientist). While a relatively minor mistake, 23andMe’s error comes at a bad time, as congress gears up to investigate genetic testing and the FDA considers restricting the industry. The future of SNP-based personal genomics is starting to look troubled.

Genetic testing is an exciting field. New discoveries into the secrets of genes are being discovered every day, and 23andMe itself is looking for genetic indicators for athleticism as well as markers for disease. Yet the industry of personal genomics is struggling with gaining widespread acceptance. The FDA spooked Pathway Genomics (a 23andMe competitor) from retailing its test kits at Walgreens, and congress is looking into the efficacy of such tests. What can someone really learn from spitting into a cup and having their SNPs analyzed? Well, they can learn some vague (and not so vague) suggestions about their health, and their ancestry. Beyond that…well the industry is still in its infancy.

Whether or not it will make it to adulthood is unclear. 23andMe isn’t the only personal genomics service which has flubbed its results. Peter Aldhous (of New Scientist) caught DeCode Genetics in a large mistake when reviewing his results from the struggling company. There’s also the looming threat that whole genome sequencing (which analyses more than 99% of a person’s DNA) may become cheap enough to directly compete with SNP-based analysis.

I am a fan of direct-to-consumer DNA analysis, as I think that every one has the right to freely access and review their genome. However, such access is virtually meaningless if consumers don’t have confidence that the information they receive is not only theirs, but also pertinent to their lives. As always, Daniel MacArthur from Genetic Futures provides some great insight into the issue. His review of 23andMe’s error reminds us that consumers must still be very cautious when receiving genetic analysis, double checking and verifying results before using that data to make health care decisions. I whole-heartedly agree.

23andMe has taken steps to keep the same mistake from happening again. From now on a customer’s sex will be used to double check that they receive their personal results (one wonders why this wasn’t done in the first place). Corrected data for each customer affected by the mix-up was sent out on June 8th.

Despite these stumbling blocks in the industry, I think it’s clear that personal genomics will continue to advance in the years ahead. There’s just too much amazing research into genetics for that not to happen. Yes, right now DNA testing can provide few certain answers, but at some point in the future genomics will be able to give us truly meaningful insight into our health and our lives. Whether or not that future arrives in time to save SNP-based direct-to-consumer companies is unclear. Hopefully 23andMe will be able to overcome this mistake and regain customer confidence. As an industry, 23andMe, DeCode, Navigenics, Pathway Genomics, and the rest need to better define (and possibly expand) what they can offer to the public in order to secure their position in the promising future of genetic testing.

[image credit:23andMe (altered)]
[source: 23andMe blog, Genetic Futures, New Scientist]