FDA Approves First Home Test For Breast Cancer Risk

FDA Approves First Home Test For Breast Cancer Risk

FDA Approves First Home Test For Breast Cancer Risk

Mutations in these genes raise a person's risk for breast, ovarian, and prostate cancer.

It's called 23andMe, and tests for three of the more than 1,000 genetic mutations linked to breast cancer.

Audio will be available later today. "The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk".

Experts say the three genetic mutations found in the 23andMe test are most commonly found in Jewish people.

BRCA mutations account for about 50 percent of hereditary breast cancers and up to 65 percent of those who inherit the mutations will develop breast cancer. But those mutations are not the most common BRCA mutations in the broader population.


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". "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement. The evaluation, through the FDA's pathway for novel, moderate-risk medical devices, required greater than 99 percent accuracy and repeatability for the assay to be approved. The agency also noted that most cancers do not arise from genetic mutations but more likely from a combination of factors, including lifestyle and environmental factors.

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.

Still, the company, which already tests DNA for other health risks as well as ancestry, said this cancer test is "a step in the right direction".

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.

Related news



[an error occurred while processing the directive]