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posted by martyb on Wednesday March 07 2018, @03:22PM   Printer-friendly
from the it's-a-start dept.

The FDA will allow the genetic testing company 23andMe to offer information about three common BRCA mutations that can have an influence on breast cancer risk. According to the FDA, the test should not be used as a substitute for seeing a doctor:

The Food and Drug Administration for the first time has authorized a genetic testing company to offer screenings for three breast cancer mutations common in Ashkenazi Jews, giving consumers the ability to initiate testing at home and see results without talking to a doctor or counselor.

The agency's action on Tuesday permits the testing company, 23andMe, to report results as part of its $199 Health and Ancestry product, which uses DNA from saliva samples to inform customers about their families' countries of origin, along with information on genetic health risks. There will be no extra charge for the additional reports, which should be available in a few weeks to customers who actively opt in and request to see them, company officials said.

[...] But testing negative for the three mutations does not mean someone is in the clear, as there are over a thousand BRCA mutations associated with increased cancer risk. Some critics say that comprehensive genetic testing — an exhaustive analysis to detect all mutations associated with an increase in breast cancer risk — is preferable. Physicians, geneticists and policymakers have long been concerned that the enthusiasm over personalized medical information and genetic testing may place consumers who misunderstand or misinterpret results at risk of jeopardizing their health. Even for Jews of Ashkenazi descent, whose families originated in Eastern and Central Europe and who are most likely to test positive for the three mutations, testing negative is no panacea, as they may carry other mutations that increase cancer risk.

Also at STAT News, Reuters, and The Verge.

Related: FDA Permits Marketing of 23andMe Direct-to-Consumer Genetic Test
Color Genomics Launches a $249 Genetic Test for Breast Cancer Risk
23andMe Genetic Test Relaunches, but Transparency Report Reveals Law Enforcement Data Requests
FDA to Allow 23andMe to Sell Genetic Tests for Disease Risks


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  • (Score: 0) by Anonymous Coward on Wednesday March 07 2018, @04:55PM (1 child)

    by Anonymous Coward on Wednesday March 07 2018, @04:55PM (#649063)
    insular breeding populations will have higher incidences of specific genes, good or bad
    like how the scots have so many redheads. it's because it's all redheads banging other redheads and no dominant brunettes to mess it up
    you guys need to stop banging each other
  • (Score: 0) by Anonymous Coward on Wednesday March 07 2018, @07:47PM

    by Anonymous Coward on Wednesday March 07 2018, @07:47PM (#649132)

    I agree, they need to let me join them.