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FDA Approves First Home Test Kit for Breast Cancer

FDA Approves First Home Test Kit for Breast Cancer

This past April, for the first time, the Food & Drug Administration (“FDA”) approved a kit to test for breast cancer risk that consumers can purchase “over the counter” without having to go through their doctor first. Offered by 23andMe, which is best known for its ancestry DNA testing, the kit involves taking a saliva test to identify three genetic mutations associated with increased breast cancer risk. The FDA warned that the particular mutations tested affect only a limited number of people and that the kit should not be used as a substitute for regular medical screenings. However, the FDA’s decision is the first step in the availability of direct-to-consumer genetic tests, and what better way to start than with breast cancer.

On average, 1 in 8 women in the United States will be diagnosed with breast cancer. It is estimated that a woman is diagnosed with breast cancer every two minutes. Sadly, it is also estimated that a woman dies of breast cancer every 13 minutes. While breast cancer is most commonly diagnosed in women, it can also affect men. Statistics show that an estimated 2,470 men are diagnosed with breast cancer each year.

For women, the 23andMe test kit produces a report which describes if she is at an increased risk of developing breast cancer and/or ovarian cancer. For men, it describes if he is at an increased risk of developing breast cancer and/or prostate cancer. However, again, the test only detects three out of more than 1,000 known mutations. “[A] negative result does not rule out the possibility that an individual carries other…mutations that increase cancer risk,” a press release issued by the FDA warned. Moreover, most cases of cancer are not caused by hereditary gene mutations but are thought to be caused by other factors such as smoking, obesity and other lifestyle factors.

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