Opinion | 23andMe Responds: Empowering Consumers

To the Editor:

Re “Why You Should Be Careful About 23andMe’s Health Test” (editorial, nytimes.com, Feb. 1):

We were surprised to read your editorial criticizing the 23andMe direct-to-consumer genetic test and warning customers to be wary. For 13 years, 23andMe has been paving a way forward for customers to get affordable access to potentially lifesaving genetic information, without the barrier of having to go through a medical professional. Our reports covering risks for hereditary breast cancer, Parkinson’s disease, harmful blood clots, and inherited lung and liver disease are just a few that have significantly affected lives.

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.

The Food and Drug Administration sets a high bar for accuracy and user comprehension. The reports authorized by the F.D.A. have gone through a rigorous process that has shown they are both clinically and analytically valid, far different than the “parlor trick” test the editorial refers to. We spent years proving to the F.D.A., through detailed analytical testing, that our Genetic Health Risk reports meet accuracy thresholds of 99 percent or higher.

More equitable health care will come only if we can provide direct access — access without a medical professional barrier — in affordable ways. We believe that consumers can learn about genetic information without the help of a medical professional, and we have the data to support that claim — specifically, user comprehension studies showing greater than 90 percent understanding of the concepts in our reports, including that a 0 variant or “negative” result does not mean forgoing other recommended screenings.

Many people do not meet the criteria for diagnostic testing through their medical professional, thus inhibiting access. Insurance companies have well-defined, restrictive criteria around who can qualify for tests like BRCA such as a family history of disease and/or specific ancestral origins. We have seen over the last decade that many customers do not in fact know their family history or ancestral origins and thus would never qualify.

Several studies show that as many as 50 percent of people with one of the three well-established BRCA1 and BRCA2 gene variants that 23andMe tests for would not qualify for traditional screening under current guidelines. Women who carry one of the variants we test for have a 45 to 85 percent risk of developing breast cancer versus 12.4 percent in the general population. For those who carry one of these variants — and we have thousands of customers who do — knowing that information is medically important.

There are significant opportunities for all of us to have better health care, prevent disease and live better lives — but that comes from individuals actually being empowered to take more control of their health.

Anne Wojcicki
Mountain View, Calif.

The writer is chief executive and co-founder of 23andMe.

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