23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post Reply
User avatar
Julie G
Mod
Mod
Posts: 9187
Joined: Sat Oct 26, 2013 6:36 pm

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by Julie G »

Good point, NF52. Given the extreme variability of the statistical reporting, perhaps we should replace" 87%" (worst case scenario) with "high":
WARNING: Learning of the carriage of APOE-ε4 may cause distress. Think carefully before unlocking this information. While the gene is not deterministic, some statistics suggest that homozygotes have a high risk of developing the disease in their lifetime. Alzheimer’s is currently considered to be incurable, but there may be prevention strategies that can delay/mitigate onset of the disease. Unfortunately, deciphering the most helpful strategies is often confusing. ApoE4.Info is a grassroots non-profit that offers both support and cutting edge information to carriers of this gene. Genetic counseling is another option for anyone who needs additional support.
circular
Senior Contributor
Senior Contributor
Posts: 5565
Joined: Sun Nov 03, 2013 10:43 am

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by circular »

Or 'significantly elevated' (since everyone living a long life has a pretty high risk of AD, though I don't know the figures for that).
ApoE 3/4 > Thanks in advance for any responses made to my posts.
User avatar
Julie G
Mod
Mod
Posts: 9187
Joined: Sat Oct 26, 2013 6:36 pm

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by Julie G »

Huge thanks to all who participated in this discussion! As a result, our dedicated team has created a new page that we've linked to our Welcome entitled Thinking about Testing? to help prepare those who are considering this step. Feel free to offer feedback.
circular
Senior Contributor
Senior Contributor
Posts: 5565
Joined: Sun Nov 03, 2013 10:43 am

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by circular »

Wow, fantastic job!

I've had a couple friends ask if I thought they should get tested, and one way I put it to them is by asking ... if they got a positive result, would they become more lax in their lifestyle decisions thinking those decisions don't matter as much. This can be a problem since age is still the #1 risk factor, so they are at risk whether e4 or not, and not being e4 may falsely reassure them they don't have to worry about preventing AD. Not sure you want to complicate your already good presentation that way though.
ApoE 3/4 > Thanks in advance for any responses made to my posts.
Nancy
Contributor
Contributor
Posts: 460
Joined: Wed Jun 08, 2016 1:30 pm

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by Nancy »

Great idea for a warning, JulieGee. I don't have time to check right now, but if I remember correctly, I think the article said there would be some kind of warning for the gene.
3,4
User avatar
Julie G
Mod
Mod
Posts: 9187
Joined: Sat Oct 26, 2013 6:36 pm

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by Julie G »

Thanks, Circ & Nancy. Yes, the plan was to create a sample warning, (not included on this page,) as a suggestion for medical information companies who regularly distribute this information. Many of these companies already have their own version of a warning, but surprisingly many (especially cardiovascular testing sites) do not. My plan is to reach out to all with our sample warning and a link to this page. Providing this service touches upon both our mission to support E4 carriers, but also to educate health professionals and the public at large.
User avatar
Gilgamesh
Contributor
Contributor
Posts: 1711
Joined: Sat Oct 26, 2013 11:31 am
Location: Northeast US mostly
Contact:

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by Gilgamesh »

Excellent work everyone. Glad to see this happen.

Until recently I wasn't spending much time in English-speaking countries so I'm easily stymied by my native language (for ex., people didn't used to use "issue" to mean problem when I left the US – it seems Bill Gates' attempt to avoid saying "bug"/problem caught on big time; really threw me last year when I returned). But "Thinking about testing" seems like maybe it should be "Thinking about getting tested"? But again, maybe I'm just being linguistically old-fashioned.

And if we can get some more global links to genetic counselors that would be great. I haven't been able to find any reliable ones (not even WHO has any).

G
User avatar
TheBrain
Contributor
Contributor
Posts: 1413
Joined: Fri Oct 03, 2014 12:12 pm

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by TheBrain »

I received an email this morning from 23andme about the availability of four of the ten new Genetic Health Risk reports. The four reports are for Parkinson's disease, late-onset Alzheimer's disease, hereditary thrombophilia, and alpha-1 antitrypsin deficiency.

The only report showing that a variant was detected was for Alzheimer's. It states, as I expected, that I have two copies of the e4 variant of ApoE.

Regarding my risk, this is what the report says:
Although your risk may be increased, many people with this variant do not develop late-onset Alzheimer's disease.
Studies estimate that an average woman of European descent with this result has a 28% chance of developing late-onset Alzheimer's disease by age 75 and a 60% chance by age 85. There is not enough data to estimate the chances in women of other ethnicities.


I would have thought that my chance of developing Alzheimer's by age 75 would have been higher than 28%. Have I been exaggerating my risk, scaring the crap out of myself unnecessarily? :o
ApoE 4/4 - When I was in 7th grade, my fellow students in history class called me "The Brain" because I had such a memory for detail. I excelled at memorization and aced tests. This childhood memory helps me cope!
User avatar
WhatNext
Senior Contributor
Senior Contributor
Posts: 124
Joined: Thu Jun 30, 2016 8:08 am

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by WhatNext »

I got the 23&me email on Wednesday. APOE was my only variant too. I'm 3/4, and they are really minimizing the risk:

"You may have a slightly increased risk of developing late-onset Alzheimer's disease based on your genetic result.
Although your risk may be slightly increased, most people with this variant do not develop late-onset Alzheimer's disease.
Studies estimate that an average woman of European descent with this variant has a 5-7% chance of developing late-onset Alzheimer's disease by age 75 and a 27-30% chance by age 85."

Note that it says I may have a slightly increased risk. I'm pretty sure APOE4 is definitely associated with increased risk :?: Promethease describes 3/4 as increasing the risk by 2x the normal risk, but it also describes one of the snps that defines APOE4 as increasing the risk by 3x, which has always confused me. :?

WhatNext
User avatar
Julie G
Mod
Mod
Posts: 9187
Joined: Sat Oct 26, 2013 6:36 pm

Re: 23andMe, Inc. Granted First FDA Authorization to Market Direct-to-Consumer Genetic Health Risk Reports

Post by Julie G »

Alysson & WhatNext, do they cite a specific resource for determining your risk level?
Post Reply