FDA OKs home test for breast cancer gene, but experts have concerns

Denise Dador Image
Wednesday, March 7, 2018
FDA OKs home test for cancer gene
A sample of your saliva is all it takes to find out if you possess specific genetic changes associated with a higher risk for breast, ovarian and prostate cancer.

A sample of your saliva is all it takes to find out if you possess specific genetic changes associated with a higher risk for breast, ovarian and prostate cancer.

The FDA just cleared a new genetic test that would be sold directly to consumers.

"It does explain what it's looking for and what it's not looking for," said Dr. Ora Gordon from Providence Medical Institute. "But I think that would be lost on a lot of people."

The new 23andMe gene test detects three out of more than 1,000 BRCA mutations.

Gordon, a medical genetics specialist with the Disney Family Cancer center, says a negative result would give consumers a false sense of security.

"It gives people a misunderstanding of what they're getting and false reassurance if it's not positive that they're off the hook," Gordon said.

23andMe's CEO Ann Wojcicki in a post said why it's a helpful test. "So many people fall through the cracks in the current system leaving them unaware of their risk," Wojcicki wrote.

But Gordon says the three genetic mutations are only pertinent to people of Ashkenazi Jewish descent. "It is highly relevant to that very specific ethnic background and generally irrelevant to almost everybody else," she said.

"The test also does not provide information on a person's overall risk of developing any type of cancer," the FDA said. "The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor."

The test is found online. You pay $200 and the kit is sent to your home. But thanks to better technology, Gordon says geneticists can offer you a more comprehensive test for just $50 more.

"You can get clinical grade testing for every known hereditary cancer susceptibility for $250," Dr. Gordon said.

Experts say at home testing is fine for fun facts about your ancestry, but genetic health tests should be done with a genetic counselor.

"I think that the risk for misinformation is very high," Gordon said