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FDA Approves First Home Test For Breast Cancer Risk

Photo from 23andMe

The US Food and Drug Administration has approved the first home test for consumers to check breast cancer risk.

The DIY test, manufactured by genetics company 23andMe, looks for three DNA mutations that are most often found in Jewish people, NBC News reports. There is no need for a prescription to take the test.

The FDA said in a statement,

These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.

This approval is expected to raise concerns over whether or not people should ask for professional medical help, as this information may not be appropriately handled by everyone, cancer experts said.

The test is fairly straightforward. The FDA added, “The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer.”

However, this does not find all genes that cause cancer, the FDA cautioned. “The test only detects three out of more than 1,000 known BRCA mutations. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.”

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.”

Erica Ramos, the organization’s president, said, “Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results.”

Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent.

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