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[Vanillalite]

Forbes

23andMe, a genetic testing startup that captured the national imagination a decade ago, appears to have fully emerged from the wilderness. The Food and Drug Administration has cleared the startup to market $199 genetic tests that will tell consumers not whether they have a condition like Parkinson's or Alzheimer's, but how likely they might be to get it.

In November 2013, 23andMe provided people who purchased its test kits, spit in a vial and mailed it in information on 254 health conditions. Then the FDA required the company to withdraw all its tests for genetic risks related to health from the market because the company had not established the efficacy of its tests and had gone silent on regulators. In February 2015, the FDA cleared 23andMe to provide consumers with information about genes they might carry that might affect their future children. But the bar was lifted even further today, particularly because the FDA says it intends to grant 23andMe and exemption that will allow it to introduce new tests far more easily.

Experts had mixed responses to the decision. George Demetri, director of the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute, praised the FDA for "thinking ahead and accelerating progress" in a tweet. Anirban Maitra, scientific director of the Ahmed Center for Pancreatic Cancer at M.D. Anderson Cancer Center, tweeted, "The potential for quackery & snake oil salesmanship this will result in is mind boggling."

"It could be worse," says Hank Greely, director of the Center for Law and the Biosciences. "It might not be a bad thing. I’m not enthusiastic. I’m not convinced this will improve Americans' health or make consumers better off. But I’m not convinced that it won’t."

One reality is that the science around such tests has changed since the FDA's original action, which was caused as much by 23andMe's clumsy refusal to respond to the FDA's queries as by the science. "Since that whole debacle at the FDA, many genetic risk scores have been published, in top-tier journals," says Eric Topol, director of the Scripps Translational Research Institute in La Jolla, Calif. "This whole idea of genomic risk for common diseases is a real deal. I think 23andMe and other companies provide information and education; I think that’s a good public service."

The disorders that will be included in the test are, verbatim from the FDA press release:

Parkinson’s disease, a nervous system disorder impacting movement
Late-onset Alzheimer’s disease, a progressive brain disorder that destroys memory and thinking skills
Celiac disease, a disorder resulting in the inability to digest gluten
Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease
Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements
Factor XI deficiency, a blood clotting disorder
Gaucher disease type 1, an organ and tissue disorder
Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition
Hereditary hemochromatosis, an iron overload disorder
Hereditary thrombophilia, a blood clot disorder

 

[guek]

This might help patient satisfaction but not patient outcomes. That's my stance. *tips doctor hat*

 

[Vanillalite]

I feel like we don't really know enough to say it'll actually do any good one way or another as the one person quoted said.

I also feel like there is potential for a lot of fakes or bad info being pedaled to people. Plus how would you really know if what they say is actually correct?

I'm conflicted on this.

 

[Dazza]

That good. Most of the diseases on that list are pretty clear cut with genetic links.

On a side note, does anyone know how easy it is to get all the raw data from 23andme when you're outside of the US and EU nowadays? I missed that early window are few years ago where they supplied more information. I take it you have to plug your data into a 3rd party app, can anyone reommend one?

 

[M0nochromatic]

That's good to hear. If people can more easily access information about their genetic history, they won't be as blindsided when any related diseases may pop up.

 

[KernelPanic]

I'd be more wary who they share such data with

 

[shiftplusone]

I don't know who my dad is so I've always been interested in doing one of these just so I can have an idea of some extra family history but haven't gone through with it

 

[kirblar]

Hereditary hemochromatosis, an iron overload disorder

Good, there's a separate Genetic test available for this anyway.

 

[cloudstrife]

I'd be more wary who they share such data with

Same.

 

[guek]

I'd be more wary who they share such data with

It should be protected under HIPPA

 

[cDNA]

I think is good. If you know Genetics applications like Galaxy you can already check by yourself the genetic variants because they provide you the raw results. This just make it more easy for the people not familiar with bioinformatics.

 

[cDNA]

It should be protected under HIPPA

In their page says They are not covered by the HIPPA

 

[Hickbilly Deluxe]

I'd be more wary who they share such data with

Why do you think they suddenly got approval? Someone's dipping their fingers into that cookie jar with a smile on their face.

 

[Eye for an Eye]

There's already tests available for these things, but it's usually done through a doctor and cost dependent on insurance.

Sure, it's nice but it's more about the risk of development than an actual disease effecting a person. Look at these women going through double mastectomies because of the genetic testing. I don't know if the harm will out weigh the good.

I can see it being a benefit to adopted people, since some will never know their biological parents. But it's such a small percentage of the population.

 

[TheMan]

i think getting this kind of info without genetic counseling could be a big problem

 

[DiscoJer]

I think it's completely absurd, if not actually insane, that that government forces a company to withhold information about a person's own DNA for fear that they might panic if they learn something potentially bad.

I mean, we are adults, aren't we? Yet we can't be trusted with information about ourselves?

This is basically just aw ay to force people to go through the existing medical industry to get such info, where they will be charged several times what this costs.

 

[lenovox1]

I think it's completely absurd, if not actually insane, that that government forces a company to withhold information about a person's own DNA for fear that they might panic if they learn something potentially bad.

I mean, we are adults, aren't we? Yet we can't be trusted with information about ourselves?

This is basically just aw ay to force people to go through the existing medical industry to get such info, where they will be charged several times what this costs.

The issue is that the data might not be accurate and that 23andMe did not fully disclose their testing methods. And there might not be conclusive genetic links to the hundreds of things 23andMe searched for before.

 

[derder]

I think it's completely absurd, if not actually insane, that that government forces a company to withhold information about a person's own DNA for fear that they might panic if they learn something potentially bad.

I mean, we are adults, aren't we? Yet we can't be trusted with information about ourselves?

This is basically just aw ay to force people to go through the existing medical industry to get such info, where they will be charged several times what this costs.

No. They're rightly concerned that others may start selling bullshit.