Published: Thu, March 08, 2018
Health Care | By Oscar Goodwin

FDA Approves Direct-to-Consumer Cancer Mutation Test

FDA Approves Direct-to-Consumer Cancer Mutation Test

It's called 23andMe, and tests for three of the more than 1,000 genetic mutations linked to breast cancer. Most BRCA mutations that increase an individual's risk are not detected by this test. The test also does not provide information on a person's overall risk of developing any type of cancer.

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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. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the USA, and could significantly raise the number of people aware of having the cancer-related mutations. It works similarly to the Company's ancestry test, with the consumer providing a saliva sample which is then analyzed to tell if a woman is at increased risk of developing breast and ovarian cancer, or if a man is at increased risk of developing breast cancer or prostate cancer. Due to the prevalence of other mutations, the test can not determine overall cancer risk, according to the FDA. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment.

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Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent. For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations. 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 company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer. 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. Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement that the utility of the test lies in offering information to a specific population that otherwise might not get genetic screening. As with the first 10 tests, the company is authorized to provide the results directly to the customer.

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