Anne Wojcicki, CEO and co-founder of 23andMe, fired back at critics who argue patients must work with physicians to interpret direct-to-consumer genetic test results.
Ms. Wojcicki's op-ed, published in STAT April 9, comes on the heels of the FDA's recent approval of a 23andMe test that reports mutations in BRCA1 and BRCA2 genes, which are linked to breast cancer. The FDA's March decision marked the first time the agency approved a direct-to-consumer genetic test to evaluate a patient's inherited risk for cancer.
Following the FDA approval, 23andMe faced backlash from critics who suggested patients who choose not to seek clinical interpretation services from medical professionals — such as a physician or genetic counselor — are at a disadvantage. Without appropriate guidance, these respondents argued a patient may not be able to contextualize their genetic test results alongside relevant clinical context and family history.
However, Ms. Wojcicki argued these critiques were reminiscent of initial reactions to a now ubiquitous direct-to-consumer product — at-home pregnancy tests.
"Forty years ago, when the first at-home pregnancy tests became available, some physicians warned against their use," she wrote. "They thought women might not be able to handle such information on their own and claimed that the results might trigger them to make irrational decisions — some went so far as to claim it would lead to suicides. Looking back, it seems unthinkable that we questioned women's ability to access this kind of information."
Ms. Wojcicki noted 23andMe had to demonstrate the company's ability to deliver information to customers in a way they understand as part of the FDA's approval process. The company's genetic health risk reports, which Ms. Wojcicki said are similar to the BRCA1/BRCA2 report, boasted a user comprehension rate of at least 90 percent.
"As is the case for at-home pregnancy tests, I believe that years from now we’ll look back and wonder why we questioned that individuals would be able to understand and responsibly act on carefully delivered health information," she concluded.
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