23andMe previously included breast cancer risk in its genetic tests in the USA, but stopped in 2013 after the FDA sent the company a warning letter stating the company was marketing its test without approval. However, even prescription-ordered genetic testing is not 100% conclusive that a person will develop cancer or not.
The FDA's review of the test determined among other things that the company provided sufficient data to show that the test is accurate (i.e., can correctly identify the three genetic variants in saliva samples), and can provide reproducible results.
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23andMe has received the first FDA authorisation for a direct-to-consumer genetic test for cancer risk. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the United States, and could significantly raise the number of people aware of having the cancer-related mutations.
These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities, according to the FDA.
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The FDA's director of the Office of In Vitro and Radiological Health, Donald St. Pierre noted that the test has a lot of caveats. Any person who comes back with a negative for these three gene mutations, for example, could still carry other mutations in the BRCA genes that elevate their 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.
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In addition to self-breast exams, which men and women are encouraged to do at home, there's also an at-home test approved by the Food and Drug Administration that consumers can buy. For all of these reasons, it is important for patients to consult their health care professional who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk. At this time, the FDA is also establishing special controls that outline the agency's expectations for accuracy, reproducibility, clinical performance, and labeling. Test results come in the form of a report sent to the user.