In an unusual broadside, the New York Times editorial board last week warned consumers that 23andMe's genetic screening tests are "more parlor trick than medicine"—and now 23andMe's CEO is pushing back against the media giant, defending the tests' accuracy and potential to increase access to genetic screening.
The New York Times' editorial board in its piece took aim at 23andMe's "new screening for gene-based health risks," which received FDA approval last month. The test can be used for to screen for risk factors related to several conditions, including celiac disease, Alzheimer's, Parkinson's, and breast cancer.
"But 'FDA-approved' does not necessarily mean 'clinically useful,'" the editorial board wrote, saying that the test's results should be interpreted "with caution."
For example, many cases of breast cancer are linked with any of 1,000 errors in the BRCA gene, the editorial board explained. But the 23andMe test looks only for certain, rare BCRA mutations that affect only two out of 100 women of Ashkenazi Jewish heritage and just one out of 1,000 women of other genetic backgrounds. It doesn't look for other BRCA mutations that contribute to breast cancer risk, according to the editorial board.
As a result, consumers may find it difficult to draw any conclusions from 23andMe's BRCA test. "Just because you test negative for the few mutations that 23andMe screens for doesn't mean you won't get breast cancer," according to the editorial. "It doesn't even mean that you won't get breast cancer caused by a BRCA mutation."
23andMe's other genetic health risk tests suffer from the same shortcomings as its BRCA test, the editorial board argued. "They look for only a handful of errors that may or may not elevate your risk of developing the disease in question. And they don't factor into their final analysis other information, like family history. … So the results will not tell you much about your actual health risks."
As a result, the editorial board claimed that "doctors and geneticists say that the tests are still more parlor trick than medicine" and recommended that, rather than using the tests, anyone concerned about their genetic predispositions to disease should contact a doctor.
23andMe pushes back
The editorial board's accusations didn't sit well with 23andMe CEO and co-founder Anne Wojcicki, who penned a sharply worded letter to the editor.
Wojcicki wrote, "While 23andMe is not a diagnostic test for individuals with a strong family history of disease, it is a powerful and accurate screening tool that allows people to learn about themselves and some of the most common clinically useful genetic conditions."
Further, Wojcicki drew attention to the rigor of the FDA approval process, writing that FDA-approved tests "have gone through a rigorous process that has shown they are both clinically and analytically valid."
She added that 23andMe "spent years proving to the FDA, through detailed analytical testing, that our Genetic Health Risk reports meet accuracy thresholds of 99% or higher." That's "far different than the 'parlor trick' test the editorial refers to," she argued.
Wojcicki also noted that many patients don't qualify for genetic health risk tests from their providers under current guidelines, meaning that 23andMe's service could fill an important gap. "More equitable health care will come only if we can provide direct access—access without a medical professional barrier—in affordable ways," she wrote.
"There are significant opportunities for all of us to have better health care, prevent disease, and live better lives," Wojcicki concluded, "but that comes from individuals actually being empowered to take more control of their health" (New York Times, 2/1; Wojcicki, New York Times, 2/5; Spitzer, Becker's Clinical Leadership & Infection Control, 2/6).
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