Published: Wed, March 07, 2018
Medical | By Marta Holmes

Test For Breast Cancer Gene Will Be Available In Weeks

Test For Breast Cancer Gene Will Be Available In Weeks

These genetic variants are known to increase a person's risk for developing primarily breast cancer, but also also ovarian or prostate cancers.

The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene mutations.

Screen Shot 2018 03 07
An example of someone's BRCA1/2 results 23andMe

The FDA has approved a direct-to-consumer test, called the Personal Genome Service Genetic Health Risk Report, that detects three specific types of BRCA1/BRCA2 breast cancer gene mutations that are the most prevalent in Jewish women of Eastern European descent (Ashkenazi). "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement.

The three mutations detected by the test occur in about 2 percent of Ashkenazi Jewish women, but only 0 to 0.1 percent of other ethnic groups, according to the U.S. National Cancer Institute. The FDA expanded that today, adding breast cancer risk testing onto the approved list.

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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.

The FDA announcement stresses that the results of the tests are limited in scope, do not mean other cancer-causing gene mutations are not present, and should not be used to determine treatments without other testing and genetic counseling.

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"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued. As with the first 10 tests, the company is authorized to provide the results directly to the customer. As part of the process, the FDA examined user comprehension data, using representative GHR test reports showing instructions and reports were generally easy to follow for the consumer. But, of course, the results of the test should in no way be taken as a replacement for a visit to the doctor. The test has the potential to provide a false sense of safety among consumers.

The FDA granted the marketing authorization to 23andMe.

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That service ended after the FDA got involved, however, with the administration citing concerns about providing that sorts of info to individuals who may not have any medical training.

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