March 17, 2018

Genetic testing company gets OK to report cancer risk to consumers

08 March 2018, 01:35 | Rodolfo Wallace

FDA OKs direct-to-consumer test for certain types of breast cancer mutations

The FDA announced it will allow the genetic testing company 23and Me to market directly its breast cancer test that will help assess 3 mutations in a common form of breast cancer gene

The DIY test, manufactured by genetics company 23andMe, looks for three DNA mutations that are most often found in Jewish people, NBC News reports.

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 National Society of Genetic Counselors recommended that people should not take the test without first consulting cancer experts, saying, "Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions". "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement. "While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual's risk are not detected by this test". The FDA expanded that today, adding breast cancer risk testing onto the approved list.

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Report for BRCA1/2 (selected variants), which evaluates an individual's risk of developing multiple cancer types, according to a press release. These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities.

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, most cases of cancer are not caused by hereditary gene mutations but are thought to be caused by a wide variety of factors, including smoking, obesity, hormone use and other lifestyle issues. During the review of the test, the FDA determined that the data showed the results are accurate and provide reproducible results. To win approval, the company submitted data showing its instructions and reports are easy to understand. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test. As with the first 10 tests, the company is authorized to provide the results directly to the customer.

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