By Karuna Jaggar, Executive Director
This piece was originally published in the San Francisco Chronicle.
I am not celebrating that the Food and Drug Administration just approved, for the first time, an at-home genetic testing kit to predict the risk of breast and ovarian cancer. It might seem as if direct-to-consumer genetic testing, which doesn’t require a doctor’s prescription, would give more people access to potentially life-saving information about their cancer risk. But the FDA’s approval of 23andMe’s new genetic test is anything but an historic step forward for women at risk of and living with breast cancer.
The FDA’s decision allows the company to report on just three out of the more than 1,000 known BRCA gene mutations. This means that a negative result does not tell a person if they are in the clear and or if they have one of the hundreds of other BRCA mutations that elevate the risk of breast and other cancers. It only means they don’t have one of the three mutations 23andMe looked for.
This is not a minor problem.
The vast majority of people will get a negative result from 23andMe. After all, some 799 out of 800 people in the United States do not have an inherited risk of breast cancer. For those who do carry a genetic mutation, the chances are 23andMe’s test won’t catch it. Most people will get an utterly meaningless result, making the test worse than useless for people who want to know if they are at increased risk of breast cancer.
This biotech company has gotten rich (and in trouble with the FDA in the past) with overblown claims about its genetic testing.
The original BRCA test was developed with Ashkenazi (Jews of Eastern European descent) families and companies have struggled to predict cancer risk for people from other ethnic backgrounds. Women of color are disproportionately likely to be told that a mutation was found, but doctors don’t know if it is harmful or not. 23andMe’s over-the-counter test deepens these existing problems by only looking for the three mutations most common to people of Ashkenazi ancestry — but these are not the most common for people of other backgrounds.
To use a crude analogy, the 23andMe test is like taking your car to your mechanic for a safety inspection. But instead of a comprehensive review of known safety concerns, the mechanic only tests for three specific things, which are common for only one car model but not your model. Even if you learn your car doesn’t have one of the three specific problems, you still don’t know if your car is safe.
The FDA’s press release states: “Consumers and health care professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries. Such decisions require confirmatory testing.” The terrifying reality is that 23andMe’s test may very likely mislead people about their breast cancer risk.
What then are we to think with the FDA’s approval? Is the product safe and effective and do the benefits outweigh the harms? Unfortunately, the FDA’s approval does more for 23andMe’s bottom line than it does for women at risk of and living with breast cancer.
The gaping limitations mean 23andMe’s test cannot effectively provide meaningful information about breast cancer risk. And the high likelihood that some consumers will not understand the results of the test arguably renders the product unsafe.
This represents a step backward. The FDA has given the green light to 23andMe to provide less information than existing tests, and in doing so it has put corporate enrichment above public health.