FDA approves popular DNA testing company home kit test for breast cancer

spinonews home kit test for breast cancer

Home kit test for breast cancer

The FDA approved a home kit test for breast cancer test for breast cancer designed by popular DNA testing company 23AndMe. Researchers in 23AndMe company are handling thousands of saliva samples from people who used the home kit to get genetic information about their family or health.

The test that we offer is a great way for those people to get access to the information directly without having to get a prescription, said, Emily Drabant Conley, VP of Business Development at 23andMe.

The company has long offered DNA testing to learn more about ancestry. Now, for the first time the FDA is allowing the company to begin testing for specific genetic mutations linked to breast cancer risk.

BRCA1/BRCA2 gene mutations

The 23AndMe test will screen for three BRCA1/BRCA2 gene mutations found in a little level of the population. They applicable primarily to people of Ashkenazi Jewish ancestry, so that’s an important limitation of the test, said, Drabant Conley.

Women who carry one of the three BRCA1 and BRCA2 gene mutations are at substantially increased risk for developing breast and ovarian cancer. In men who carry one are at higher risk for breast cancer and may at higher risk for prostate cancer as well.

Stanford University medical ethics professor David Magnus worries will confuse users. People will misunderstand and believe that because they test negative. They don’t test positive for any of the three BRCA genes that implies they have a doctor’s approval.

Magnus said, someone could still have another one of the thousands of gene mutations that aren’t covering the take-home kit. People who may get this test, it may harder to translate and comprehend those outcomes.

But company representatives say it’s something they’ve worked through with the FDA. 23andMe has needed to demonstrate that people could understand this data specifically instead of accepting it through a health care supplier.

However, the testing kit will available in the next couple of weeks on the 23andMe website. Which costs $199.