DNA tests banned after failing approval from FDA

by | Nov 29, 2013 | News

Tricia Chan
News Reporter

A Silicon Valley startup with ties to Google has had its holiday dreams decimated by the United States Food and Drug Administration, which ordered a ban on the sale of all 23andMe Testing Kits.
The kits can be used to examine the genetic background of a user for a wide range of medical conditions or tendencies.

The FDA is calling for a ban because 23andMe is not an approved health care provider and so should not be offering health care advice, which is what the testing kits apparently claim to do. The company has also failed to prove the science behind the technology.

According to 23andMe.com, the kit can be bought for US$99. It includes a vial to collect a saliva sample, which gets sent back to the company, which sends DNA results back to the customer.

The issue the FDA has is the 250 genetic health risk factors 23andMe recently incorporated into their services, with 23andMe not approved to make claims about health care.

Patrick Chung, 23andMe board member, told the magazine Fast Company in November that the long game is in collecting genetic data and the sale of kits is essential to getting there, but not their primary focus.

“Once you have the data, [the company] does actually become the Google of personalized health care,” said Chung, a board member and partner in New Enterprise Associates, one of the world’s largest venture capital firms.

Casey Hannivan, 25, said she has undergone surgeries and less invasive procedures like sleep clinics and allergy testing to deal with her undiagnosed health problems, but doctors still can’t offer an explanation.

“I’m sick all the time and I’m constantly tired and never wake up feeling rested,” said Hannivan. “Doctors treat symptoms, naturopaths look at preventative care and maintaining a good general level of health. This is more preventative treatment.”

According to Karolina Czajka, a research technician at the Ontario Institute for Cancer Research, 23andMe and her organization use technologies from the same company, Illumina, to read the human genome.

“When the first sequencing method came out it took like a billion dollars to essentially sequence on genome,” said Czajka. “And it took a couple of years to do it.”

She said 10 years later, the technology has improved exponentially, to the point where a person’s entire DNA can be sequenced for $1,000. But while she works in the field, Czajka isn’t mailing her spit to 23andMe anytime soon.

“They look at specific mutations, like the ones correlated with cancer,” said Czajka, explaianing she simply knows too much on the subject. “I think it would make me paranoid.”

Nathaniel Brown, 21, a health and fitness promotion student at Humber, said he does not have a problem with a company having his genetic information if it ends up benefitting everyone.

“I wouldn’t mind it at all,” Brown said. “The sooner you know something the better.”