The U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk Report, by 23andMe Inc., on Tuesday, which will report on three specific BRCA1/BRCA2 breast cancer gene mutations.
The drug regulator said the test, which work by analyzing DNA collected from saliva samples, provides genetic risk information but can not determine a person's overall risk of developing a disease or condition.
The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. "The variants may also be associated with an increased risk for certain other cancers".
This test analyzes a sample of saliva and screens for three mutations of the BRCA1 and BRCA2 genes. Those most at risk of developing such cancers are of Eastern European Jewish descent. "Women with one of these variants have a 45-85 percent chance of developing breast cancer by age 70".
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In a prepared statement, 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, called the approval a step forward with "a lot of caveats". 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 test was reviewed through the de novo premarket review pathway. The test report provides information about the results, how to interpret results, and where additional information can be found, according to the release.
The FDA granted the marketing authorization to 23andMe.