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Diagnostics Regulation and standards, Genetics and epigenetics, Omics

DIY Pathology Panic

“We just found out that she’s at a high risk of getting cancer. And she’s not even 40 yet,” said a gentleman ahead of me in the supermarket line. He was loud, so I couldn’t avoid listening to the rest – but I’ll admit I was also curious. The gist was this: his wife had surgery to remove a brain tumor last year, and decided to order a genetic home test kit to be aware of any other conditions that she might expect later in life. The gentleman didn’t specify the cancer type, but was adamant that his wife would be afflicted by the disease at some point in the future. Thinking back, I wish I had intervened and reassured him that the test was in no way definitive. Instead I kept silent, believing it was not my place to say anything.

The conversation took place just a few weeks after I read that 23andMe had gained the green light from the FDA to market its genetic tests direct to consumers for 10 conditions (1). It was the very first such approval and a huge win for the manufacturer – and I honestly felt unnerved by it. Not because I was wary of the strength or validity of the trial data presented by 23andMe in support of the approval, but because of the impact that widespread marketing of these tests could have on the general public. In the regulator’s press release, the director of the FDA’s Center for Devices and Radiological Health reminded, “It is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.” Will they really understand that? And will the manufacturer make it abundantly clear that its test is not a disease predictor or diagnostic but simply a disease-risk indicator?

The gentleman in the supermarket went on to say that his wife had made dietary changes to try and improve her chances of avoiding the dreaded “C.” If the test has encouraged someone to opt for a healthier lifestyle, that’s a good thing, isn’t it? But we’re approaching Mother’s Day here in the US and a TV commercial re-awoke the pessimist in me. It began: “This Mother’s Day, enjoy $20 off when you order your kit at 23andMe.com,” (with free gift wrapping!), and concluded with a little girl gushing, “I love you, Mom.” Terrifying. Let’s see what the long-term outcome is – public panic or healthier lifestyle choices? I’m hoping the “CynicalMe.com” is proven wrong on this occasion.

Fedra Pavlou

Editor

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  1. US Food and Drug Administration, “FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions” (2017). Available at: bit.ly/2oIy6gc. Accessed May 15, 2017.
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