FDA Approves First Home Test For Breast Cancer Risk

10 March, 2018, 01:29 | Author: Cassandra Gardner
  • FDA OKs direct-to-consumer test for certain types of breast cancer mutations

The newly authorized test identifies three of 1000-plus mutations associated with breast cancer risk.

Personal genetics company 23andMe announced yesterday that it's received the first-ever FDA authorization for genetic testing for cancer risk.

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The 23andMe test will only screen for three possible breast cancer mutations that are mostly seen in people of Ashkenazi Jewish descent. An oncologist at Florida Hospital says these mutations are uncommon in the general population, which means that even if it comes back negative, it doesn't mean a person won't develop the disease.

The National Society of Genetic Counselors recommended that people should not take the test without first consulting cancer experts, saying, "Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions". But, of course, the results of the test should in no way be taken as a replacement for a visit to the doctor. Only a small percentage of Americans carry one of the three mutations, and most of the 1,000 known BRCA mutations that increase an individual's cancer risk are not included in the test. "Women with one of these variants have a 45-85 percent chance of developing breast cancer by age 70". About 2% of Ashkenazi Jewish women have one of the mutations, but they occur very rarely in other ethnic groups, the FDA says. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. The FDA expanded that today, adding breast cancer risk testing onto the approved list. "You have to be prepared to share this information with your family... including the sister you haven't talked to in ten years".

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Your ancestry picture is about to get bigger and more clear. Overall, greater access to the information is "a good thing", he said, but dealing with the fallout "is just something we will have to get used to, as a culture". It can not determine a person's overall risk of developing cancer.

23andMe founder and CEO Anne Wojcikci acknowledged that most cancer is not hereditary and that this test does not cover many variants tied to an even higher cancer risk.

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