Academics decry FDA crackdown on genome service companies

January 16, 2014 by Bob Yirka, Medical Xpress report
genome

(Medical Xpress)—Dr. Robert Green, a medical geneticist with Brigham and Women's Hospital and Nita Farahany, professor of genome sciences and policy at Duke University, who also happens to be a lawyer have stepped into the "controversy" surrounding companies that provide genetic testing for anyone who wants it. Together the two have published a COMMET piece in the journal Nature, arguing against a recent order by the FDA, that 23andMe, a genome services company, cease offering services that offer medical advice.

As has come down in price, it's moved from research labs into the private sector with some companies now routinely offering genome services to the public. Such companies offer genealogy information, which is not considered controversial and/or quasi such as letting people know if they have markers in their genes that make them more susceptible to certain diseases. This type of service has become controversial chiefly because it hasn't become anywhere near foolproof—consumers report receiving different information from different testing companies. Because of this, the FDA chose to inject itself into the situation—last month they sent 23andMe a letter telling the company to stop offering such services. Now, Farahany and Green are responding to that letter and the possible impact it might have on genomic services in general.

Farahany, a onetime customer of 23andMe, and her colleague, argue that the FDA has overstepped its bounds in classifying genomic testing services as medical devices. They also accuse the agency of engaging in speculation rather than science in cracking down on such services and back up their allegations by listing several studies (some of which were conducted by 23andMe) that showed that consumers are not adversely impacted by such services. The FDA had suggested that some consumers may alter their medications or medical practices due to genome reports they receive. Farahany and Green also contend that the FDA's main reason for halting such services is out of fear of customer reaction should they be told they have a genetic predisposition to breast cancer. Farahany and Green cite more studies that have shown that the vast majority of consumers who receive such information immediately consult their physician and only take action if they are advised to do so by their doctor (as was the highly public case of celebrity Angelina Jolie.)

Nature’s Kerri Smith looks at the recent FDA crackdown on personal genomics company 23andMe. Credit: Nature

The FDA has yet to respond to the comment piece, but the article does shed light on the increasingly common practice of consumers seeking medical information by having their genes scrutinized—a practice that in the long run should be good for everyone. As more people have it done, more information becomes available which should over time help to improve the accuracy of such tests. Whether they should be held under the guidance of the FDA, however, is still unclear and may ultimately have to be resolved by the courts.

Explore further: It is game over for 23andMe, and rightly so

More information: Regulation: The FDA is overcautious on consumer genomics, Robert C Green& Nita A Farahany, Nature, DOI: 10.1038/505286a

Related Stories

It is game over for 23andMe, and rightly so

November 27, 2013
The market for personal genome services is facing a reality check. While the most prominent and innovative company 23andMe has flourished so far, in the past few years many of its competitors have gone out of business. Now, ...

US tells 23andMe to halt sales of genetic test

November 25, 2013
The U.S. Food and Drug Administration is ordering genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is backed by science.

New study launched investigating the impacts of personal genomic testing

March 5, 2012
As genetic risk information plays an increasingly important role in the diagnosis and treatment of many diseases, private companies have made personal genomic testing for these risk factors widely available to the public. ...

Putting the brakes on home genetic testing: Four questions with geneticist Scott Diehl

December 4, 2013
The Food and Drug Administration recently ordered an end to sales of the home genetic testing kit 23andMe. FDA medical experts said the kit's manufacturers had failed to prove their claim that the $99 test can help customers ...

23andMe faces class action lawsuit in California

December 3, 2013
Genetic testing company 23andMe is facing a class action lawsuit alleging that the Silicon Valley startup misled customers about its test kit.

USPSTF supports counseling, BRCA tests for at-risk women

December 24, 2013
(HealthDay)—Nine of 10 women do not need and should not receive genetic testing to see if they are at risk for breast or ovarian cancer, an influential panel of health experts announced Monday.

Recommended for you

Peers' genes may help friends stay in school, new study finds

January 18, 2018
While there's scientific evidence to suggest that your genes have something to do with how far you'll go in school, new research by a team from Stanford and elsewhere says the DNA of your classmates also plays a role.

Can mice really mirror humans when it comes to cancer?

January 18, 2018
A new Michigan State University study is helping to answer a pressing question among scientists of just how close mice are to people when it comes to researching cancer.

Two new breast cancer genes emerge from Lynch syndrome gene study

January 18, 2018
Researchers at Columbia University Irving Medical Center and NewYork-Presbyterian have identified two new breast cancer genes. Having one of the genes—MSH6 and PMS2—approximately doubles a woman's risk of developing breast ...

A centuries-old math equation used to solve a modern-day genetics challenge

January 18, 2018
Researchers developed a new mathematical tool to validate and improve methods used by medical professionals to interpret results from clinical genetic tests. The work was published this month in Genetics in Medicine.

Epigenetics study helps focus search for autism risk factors

January 16, 2018
Scientists have long tried to pin down the causes of autism spectrum disorder. Recent studies have expanded the search for genetic links from identifying genes toward epigenetics, the study of factors that control gene expression ...

Group recreates DNA of man who died in 1827 despite having no body to work with

January 16, 2018
An international team of researchers led by a group with deCODE Genetics, a biopharmaceutical company in Iceland, has partly recreated the DNA of a man who died in 1827, despite having no body to take tissue samples from. ...

3 comments

Adjust slider to filter visible comments by rank

Display comments: newest first

Zera
not rated yet Jan 16, 2014
I am a member of 23 and Me, and contribute to 23 and We.

I read carefully the agreement, I understand the risks and considerations. The advice is just that, with careful weight placed on how likely a marker is actually a meaningful indicator of characteristic.

Each person must decide for themselves, makes me wonder what the real FDA motivation is, potentially lobbying by pharma companies, who see genetically tailored drugs as waves of the future?
technodiss
not rated yet Jan 17, 2014
this is great tech that helps a lot of people. but if you're getting different results from different places, someone is doing something wrong. so i think there should be oversight for quality control. if something isn't certain its likelihood should be shown. but simply saying, "it's not perfect so stop it," is a bit over the top, ESPECIALLY for the fda.
bmorrow492
not rated yet Feb 21, 2014
"The FDA had suggested that some consumers may alter their medications or medical practices due to genome reports they receive."

Some consumers may alter their medications based on what they read about side effects. Does the FDA thereby conclude that it should ban disclosure by drug companies about drug side effects?

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.