FDA approves first at-home breast cancer test

Local genetic researchers evaluate test

DANVILLE, MONTOUR COUNTY (WBRE/WYOU) -- Do-it-yourself health test kits have been around for years but now there's something new. The Food and Drug Administration just announced on Tuesday it approved the first at-home test kit for breast cancer risk.

A company best known for its ancestry DNA testing is behind this development. As Eyewitness News Healthbeat Reporter Mark Hiller explains, the question is how accurate is this breast cancer test kit and can it do more harm than good?

Detecting breast cancer could be as simple as a saliva test in the comfort of your home. At least that's what the health and ancestry testing company 23andMe says will be possible now that the FDA made the kit the first direct to consumer DNA test for breast cancer gene mutations. 

"One of my first thoughts is how the general public would react to that," said Geisinger Genetic Researcher Christa Martin, Ph.D. She is concerned many who may test negative at home for breast cancer risk might think they're in the clear. "There are thousands of changes in those genes that can cause or increase risk for breast cancer and this test is looking at three of them."

The three BRCA1/BRCA2 breast cancer gene mutations occur in about 2% of Ashkenazi Jewish women but rarely anyone else. "It's important that if you have a negative result you know that that doesn't in any way decrease your risk of having a genetic change that's related to breast cancer," she said.

Dr. Martin and fellow geneticist Andy Faucett conduct genetic research for Geisinger's MyCode. The community health initiative aims to develop precision health based on DNA findings and treat disease better or even prevent it. Mr. Faucett acknowledges the limits of 23andMe as a diagnostic test for breast cancer. "If you have a family history of breast cancer it's probably not the best test for you."

However, Mr. Faucett does believe the at-home DNA test kit of your 23 chromosomes has value. "With this test, you're just not looking at those changes related to breast cancer. You're getting the full 23andMe panel. There's a lot of genetic data captured that can then be used to look for other genetic causes of disease or other associations."

23andMe already tests for diseases like alzheimer's and parkinson's and wellness factors like saturated fat and lactose intolerance. It will add breast cancer gene mutation testing in the coming weeks to its health and ancestry services at no additional cost.

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