California Firm's Cancer Test-By-Mail Get FDA Approval — But Not Necessarily From Doctors
The Silicon Valley company 23andMe can tell you about your ancestry, your geographic origins and your risk for diseases like Alzheimer’s and Parkinson’s — all based on a swab of saliva.
Now, they’ve got approval from the U.S. Food and Drug Administration to test for mutations in the a gene that indicates heightened risk for breast, ovarian, prostate and pancreatic cancers.
The company will be the first mail-in service to test for this mutation. But some doctors are cautioning against getting this sort of information through the mail.
Though the test only explains risk for certain conditions and does not give a formal diagnosis, Dr. Beth Karlan with the Cedars Sinai Women’s Cancer Program in Los Angeles says the results could be more confusing than helpful.
“Especially if it’s positive,” she said. “There’s a concern this test result will be misinterpreted by the patient, by them not completely understanding what it says or doesn’t say.”
The company was previously prohibited from testing for cancer because the results could lead consumers to seek additional screening, confirmatory procedures, or treatments that could cause harm.
Karlan worries people will either brush off the test or take it too seriously. For example, the 23andMe kit only screens for the three most frequent mutations of the BRCA gene. Butin reality there are thousands that have been associated with cancer risk, so a negative on the saliva test doesn’t mean you’re in the clear.
Also, the three mutations in the test are most closely associated with cancer risk for people of Ashkenazi Jewish descent. This means people who test positive but don’t share that ancestry could end up worrying — and seeking treatment — unnecessarily.
Karlan said she usually spends about an hour explaining positive BRCA results to patients.
“Not every person has the basic medical knowledge to know what to do with this information,” she said.
A spokeperson with 23andMe wrote in an email that its health reports include information about the variants the kit tests for and the different factors involved in cancer risk.
“We think that people have a right to access this information if they choose,” the statement read. The company cited its extensive FAQ section on its website, plus information on resources and next steps.
Auser comprehension study conducted by the company found that more than 90 percent of consumers understood 23andMe report results.
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