Earlier this year, a drug store chain was three days away from putting home genetic tests on its shelves for sale to the public. Previously, these had been for sale online.

As this test was not seen as a medical device or test—it has been used by family history buffs—the FDA had no notice of the new use.

A Washington Post story broke the news.

The FDA asked for evidence that these home genetic tests were not under its jurisdiction, the drug chain said it would follow the FDA advice and a firestorm erupted.

Many, including this editor, feared that people could be unprepared for what they could learn—the risk of a serious or life-threatening disease. The companies claimed that they were offering telephone “support,” although that was not described.

This Medpage Today story says that the GAO conducted an undercover investigation and the results confirmed some of the concerns had a sound basis.

One undercover agent was told she could secretly test her fiance’s genes, which is illegal in 33 states.

A test user who showed to be an in above-average risk group for breast cancer was told that she was “in the high risk of pretty much getting” breast cancer.

“Pretty much getting” sounds like a diagnosis but is not.

Imagine being a person who was told this news or news like it.

Medpage Today

“Home genetic tests often provide incomplete or misleading information to consumers, according to an undercover investigation by the Government Accountability Office (GAO).

“In testimony to the House Energy and Commerce Subcommittee on Oversight and Investigations, Gregory Kutz, a GAO investigator, described an instance in which a representative of Pathway Genomics said the company could test a woman’s fiance’s genes without the man knowing.

“The company told the bride-to-be (another GAO investigator) that she could give her fiance the results as a gift. The company, the GAO investigators said, made this offer even though secretive DNA testing is restricted by law in 33 states.

“In another scenario, another maker of genetic tests, Navigenics, told a donor that receiving an above-average risk prediction for breast cancer meant she was “in the high risk of pretty much getting” breast cancer. According to a GAO report, experts found that statement “horrifying,” because the tests are not supposed to be used to diagnose diseases.” (Emphasis added)

Source: Medpage Today, July 22, 2010