Local doctor, patient discourage use of newly-approved 23andMe cancer risk test
MADISON, Wis — On March 6, the Food and Drug Administration gave popular genetic testing company 23andMe the green light to test for BRCA genes related to breast and ovarian cancer, but some believe the results will confuse customers and leave them with no support.
“People get a test result and then immediately want to fix it,” Shelley Luedtke said. “If I wouldn’t have had a genetic counselor to talk to about what do I do now, I don’t know where I would’ve gone.”
Luedtke, 44, of Sun Prairie was diagnosed with the BRCA 1 gene at age 29. She watched her mother and grandmother lose their battles to ovarian cancer at early ages.
After the test came back positive, her doctor scheduled an immediate hysterectomy and recommended a complete mastectomy.
Doctors estimate people with the BRCA 1 gene have a 90 percent chance of getting breast cancer in their lifetime, and about a 40 percent chance of getting ovarian cancer.
“I’ve taken the steps to change that for myself. Not to say that it won’t happen, but I don’t have any ovaries so I hope that I don’t get ovarian cancer,” Luedtke said.
Now she is helping others in the same situation by volunteering as a peer navigator with the organization FORCE, or Facing Our Risk of Cancer Empowered.
She encourages others who have a family history of cancer to get tested, but she does not recommend the new 23andMe test.
The @US_FDA approved #BRCA testing by @23andMe, but doctors say the test is limited. It only tests for 3 of the most common mutations. Customers could get a negative result, but still be positive for 1 of hundreds of other mutations, making them more likely to get #breastcancer. pic.twitter.com/bHyYV1Y1eU
— Amanda Quintana (@AmandaQTV) April 2, 2018
In the next few weeks, 23andMe will offer the first-ever direct-to-consumer genetic test for cancer risk. It will allow people to get tested for BRCA by mailing in their saliva in the privacy of their home, without speaking to a doctor or genetic counselor.
But the test only looks for the three forms of BRCA 1 and BRCA 2 mutations that are most common in the Ashkenazi Jewish population, out of hundreds of BRCA variations.
“One of the most frustrating things is you can imagine a consumer buying this product and saying ‘Ok, I got tested. My test result was negative. I don’t have to worry about carrying an abnormal gene and I don’t have to worry about my cancer risk.’ That is just completely farcical,” Dr. Lisa Barroilhet said.
Barroilhet works with patients at the UW Health Carbone Cancer Center who have a high risk of developing cancer. She said discussing BRCA results is a conversation patients should have with their physician.
“Actually the FDA specifically stipulated in the approval that clinical action should not be taken based on these test results. So if you’re a patient who gets a 23andMe test that comes back positive, you then have to go to your physician and have them repeat the test by a certified laboratory, to make sure it’s in fact correct,” Barroilhet said.
Luedtke agrees. She said seeing a positive or negative result on a computer screen won’t give people the support they need.
“I feel like there’s so much information out there, and unless you are given the tools to know where to find that information, you’re kind of left in the dark,” Luedtke said.
A spokesperson for 23andMe said customers will receive an eight-page education module with their results.
“In it we are very clear about many factors, including providing resources for people who might receive a positive variant outcome,” said the spokesperson.
It will outline the details about the testing so consumers are clear about what the company is testing for, including some of the limitations of the test.
She said the results will clearly state, “Please share your result with a healthcare professional. It is important to confirm this result in a clinical setting before taking any medical action.”
The results will also include resources about support groups, genetic counseling and how to discuss results with family.
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