FDA approves 1st at-home genetic testing kit, but experts wary of results

Denise Dador Image
Saturday, April 8, 2017
FDA approves 1st at-home genetic testing kit
For the first time, the FDA approved the sale of an at-home genetic test that gives information about a person's risk for certain diseases. A California company will now market that genetic test.

LOS ANGELES (KABC) -- For the first time, the FDA approved the sale of an at-home genetic test that gives information about a person's risk for certain diseases. A California company will now market that genetic test.

The company 23andMe was approved to market their personal genome health risks test that screens for 10 different diseases and conditions.

You provide a saliva sample and send it in. The company then looks at your DNA for 500,000 genetic variants. Neurologist Dr. Yafa Minazad was not a fan.

"Putting those types of tests in the hands of consumers and giving them the option of going for them can be both dangerous and also misleading," she said.

According to Minazad, there is no genetic test that could determine 100 percent whether you're going to get Alzheimer's or Parkinson's, so the question is how can this test help you?

"Putting this in the hands of the consumer with a test that has that gray zone of false positive, false negative, is going to be a disaster," Minazad said.

Your results are delivered online.

"If this goes into your medical record it's not going to be very difficult for people to have access to it or to be discovered," Minazad said.

And there were concerns about what people might do once they get results.

Eyewitness News called 23andMe and were told they don't provide genetic counseling. They advised talking to your doctor.

The FDA cautioned that genetic risk is just one piece of information and does not mean a person will eventually get the disease.

Currently, the 23andMe health risk test costs $199.