After struggling to receive clearance for consumers on health-related genetics testing in 2013, 23andMe has now been approved by the Food and Drug Administration. In addition to its ancestry service it now tests for genetic cancer variants.
While this may seem like a step forward for those interested in knowing whether or not they’re at risk for certain cancers, this at-home genetics test is misleading and could create a false sense of security.
— Anne Wojcicki (@annewoj23) March 6, 2018
23andMe may be trying to save people’s lives with early detection for breast, ovarian and prostate cancer, but the test is very limited in the mutations being detected. More background development and more gene variants need to be included before this test was released to the public.
The test covers only three mutations that are commonly linked to people at higher risk for breast and ovarian cancer, according to an official blog post by Anne Wojcicki, the co-founder and CEO of 23andMe.
Genetic testing is an “important part of breast cancer risk determination,” said Sora Tanjasiri, a professor and chair of the health science department at Cal State Fullerton who mainly focuses on breast cancer.
But this at-home screening is misleading to customers who are looking to seriously test their risk. While these three mutations are frequently found in individuals of Ashkenazi Jewish ancestry, they aren’t as common in the general population, according to the National Cancer Institute. In fact, there are many gene mutations outside of these that are linked to breast and ovarian malignancies.
Testing for only three mutations associated with breast cancer doesn’t even scratch the surface as only 1 in 4 cases involve these genes, according to the Genetic Literacy Project, which aims to help people understand genetic and biotechnology research. A combination of low-risk factors could actually be the culprit for cancerous growth, according to the Genetic Literacy Project.
But this at-home test bypasses doctors, who Tanjasiri said are essential in recommending genetic testing.
Genetic counseling is also not being adequately considered by 23andMe.
“An important component of genetic testing is the interpretation of the results with a genetic counselor and those are generally not available through these third-party companies like 23andMe,” Tanjasiri said. “They’ll give a print out of what they find, but it’s left up to the individual to interpret what that means for them.”
While some may argue 23andMe genetic testing motivates people to learn more about their medical history, Tanjasiri said research is still not definitive on whether or not it makes people more proactive in seeing a licensed physician.
“I recommend that women who believe they’re at higher risk for a disease like cancer talk to their doctors about what genetic testing is available, what can be done, what can they be told, and what they might be able to do with the results,” Tanjasiri said.
As the first ever FDA approved genetic cancer risk test, 23andMe is feeding consumer’s curiosity rather than providing extensive or genuine results. Genetic counseling is an important factor in the testing and its exclusion from 23andMe is concerning.
If 23andMe wants to actually offer preventative health information that will make a difference, it would provide a genetics test to offer more gene mutation testing, as well as genetics counseling to guide customers.