GAO investigators say DNA tests give bogus results

July 25, 2010

A government investigator told members of Congress on Thursday that personalized DNA tests claiming to predict certain inheritable diseases are misleading and offer little or no useful information.

An undercover investigation by the Government Accountability Office found that four companies delivered contradictory predictions based on the same person's DNA. Investigators also found that test results often contradicted patients' actual medical histories.

"Consumers need to know that today, genetic testing for certain diseases appears to be more of an art than a science," said GAO investigator Gregory Kutz, in testimony before a House Energy and Commerce Subcommittee.

The GAO presented its findings at a Congressional hearing to scrutinize the personalized genetic industry, which until recently operated below the radar of federal regulators.

Genomic testing companies market saliva-based kits designed to detect whether individuals are genetically predisposed to get certain inheritable diseases like or Alzheimer's Disease. Such tests have been sold online for years, but they began attracting federal scrutiny in May when Pathway Genomics announced plans to market its products in retail pharmacies.

That plan was scuttled by the , which said the tests must undergo federal testing.

The chief executive of Pathway testified alongside counterparts from Navigenics and 23andMe, saying their companies used the latest technology to give consumers insight into their .

But the GAO report suggests the companies still have a long way to go in drawing accurate conclusions.

The agency submitted from five staffers to four different genetic testing companies. When considering the same disease, the companies' results contradicted each other nearly 70 percent of the time, according to GAO. In response to the same patient's DNA, one company claimed he was at above-average risk for prostate cancer, a second said he was below average and two others said his risks were average.

In another case, a patient implanted with a pacemaker to control irregular heart beat was told he was at decreased risk of developing the heart condition.

"I believe, as do our experts, that these results clearly show that these tests are not ready for prime time," Kuntz said.

Kuntz told lawmakers that the tests don't constitute fraud because the companies believe in the accuracy of their methods — but they should still be subject to regulatory standards.

According to the companies, the disparate results reported by GAO are a result of different analytical methods used by each company.

23andMe CEO Ashley Gould told lawmakers the company is working with competitors and the FDA to standardize methods for analyzing genes.

As tests that predict the presence of a medical condition, genetic tests fall under the regulation of the FDA, though the agency has only recently begun scrutinizing the space.

In June the FDA issued letters to several genomic testing firms, asking them to submit their products for federal review.

FDA's device chief Jeffrey Shuren said that action was overdue.

"If there's any issue with the FDA, it's why didn't we act sooner," Shuren said.

The agency is in the process of meeting with companies and may take additional actions against the companies and their products.

Explore further: Home DNA kits have questionable results

Related Stories

At Home Genomic Tests for Disease Risk Premature

March 18, 2008

The recent marketing of "at home" genomic tests for disease risk may be premature, according to Dr. Kenneth Offit, MD, MPH, Chief of the Clinical Genetics Service at Memorial Sloan-Kettering Cancer Center (MSKCC).

Marketing of unproven genetic tests a threat to public health

April 3, 2008

No mechanism currently exists to ensure that genetic tests are supported by adequate evidence before they go to market, or that marketing claims are truthful and not misleading, according to a policy analysis to be published ...

DNA self-tests: More hype than help?

March 20, 2009

With a little spit and a few keyboard strokes, you can unlock the secrets of your DNA. At least, it seems that simple at an array of Internet sites that are pitching genetic tests directly to consumers.

FDA medical device approvals get external review

September 23, 2009

(AP) -- The Food and Drug Administration is asking the government's top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

( -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...


Adjust slider to filter visible comments by rank

Display comments: newest first

3.7 / 5 (3) Jul 25, 2010
"According to the companies, the disparate results reported by GAO are a result of different analytical methods used by each company."

Analytical methods don't matter. If the science behind it is accurate than any method will yield the same result. Only a complete fool would take this as a real answer.
3 / 5 (2) Jul 25, 2010
I find it appalling that right below the story sits "Google Ads" for similar DNA tests the story just got done warning people about!
not rated yet Jul 26, 2010
"If the science behind it is accurate than any method will yield the same result."

That's the point, the science behind the tests _is_ inaccurate at this time. It is one of the most advanced testing you can get on the market right now, so the science is still not worked out fully. And it will take many years to work it out fully.

It's not a cholesterol test that was here for a long time and is much simpler technology. And even then, different cholesterol readers will give you different readings as well! Not to mentioned that usefulness of the cholesterol test is constantly challenged by many people from the scientist to practitioners.

DNA testing is in its infancy and in my opinion it should not be stifled outright by the government regulations.
not rated yet Jul 26, 2010
I find it appalling that right below the story sits "Google Ads" for similar DNA tests the story just got done warning people about!

right on!!
absolutely despicable
no accident i'll bet
not rated yet Jul 26, 2010
LOL, you guys are silly. I bet the type of the ad displayed is selected by the key words used in this science story. This one is about DNA testing so that's what the ad is all about. :-)

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.