FDA approves first at-home test for cancer risks

08 March, 2018, 01:36 | Author: Wilson Dawson
  • FDA OKs direct-to-consumer test for certain types of breast cancer mutations

The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population.

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more.

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.


But the U.S. Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe. Only a small percentage of Americans carry one of the three mutations, and most of the 1,000 known BRCA mutations that increase an individual's cancer risk are not included in the test. She works for and mentors other survivors at Carolina's Breast Friends, an organization which provides compassion and support to people going through breast cancer. It can not determine a person's overall risk of developing cancer. 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. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor.

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.

The vast majority of people with these genetic mutations have ancestral ties to the Ashkenazi Jewish population formerly living in central Europe and Russian Federation. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test.

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