Yeah, me too. The primary reason I purchased this is that I know I have 50% odds of having a BRCA mutation (1 of my parents does). I was really looking forward to that test.
This is exactly why the FDA is acting correctly here!
Dig deep on the 23andme website and you'll find that they test for a few BRCA mutations, but not all. It's far from comprehensive, and it's not at all equivalent to a normal test that you would get from a doctor. From https://customercare.23andme.com/entries/23241132-Does-the-2... "The BRCA Cancer Mutations (Selected) report includes 3 selected BRCA mutations. The BRCA mutations covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes that can cause cancer."
I've seen several commenters here on HN making the same mistake as you. HN readers are generally smart and skeptical. If we aren't perceptive enough to see through the bullshit, how do you think the general public is going to fare?
Are the BRCA genetics well enough understood that a deep sequence of that gene is able to be adequately interpreted?
Ultimately, what you seem to be suggesting is that it is better that we not get partial data because most people won't understand that it's partial data and further won't know what to do with it. Most people are not geneticists. I sort of agree, but there is no doubt in my mind that the future will see the loosening of the physician-as-gatekeeper, and to what extent is that acceptable. Would this service be allowed if they taught cursory genetics and SNPs in the general biology curricula at the high school level?
Are the BRCA genetics well enough understood that a deep sequence of that gene is able to be adequately interpreted?
It's not my field, but I know they're well enough understood that you can get far more information from the full sequence than from a few SNPs. Even 23andme has always said the same thing on their website if you look closely.
Ultimately, what you seem to be suggesting is that it is better that we not get partial data because most people won't understand that it's partial data and further won't know what to do with it.
I wouldn't quite say that. I think partial data is perfectly fine. I'm a 23andme customer, despite understanding that it's close to meaningless from a medical perspective (I think the most valuable medical information I got was related to male pattern baldness; coolest information is the Neanderthal stuff). The problem IMHO was 23andme's marketing, which to me seemed almost as if it was designed to mislead people.
Another example... over thanksgiving I was talking to my cousin. She brought up the 23andme news because she had recently done it, but hadn't received results yet. I asked her why she got the test. First answer? BRCA. She had no idea that the 23andme test was not nearly comprehensive. And she's not just some average person not smart enough to understand things - she has a PhD from MIT (albeit not in biology, although her husband has a biology PhD), knows a lot about breast cancer since her mom had it, and is generally very cynical about stuff like this.
Would this service be allowed if they taught cursory genetics and SNPs in the general biology curricula at the high school level?
I think high school curricula are irrelevant to the discussion, for multiple reasons. The vast majority of high school students don't have the background to understand this stuff. Even if they did, most wouldn't care enough to remember it. And even if they did care, the science is changing rapidly - it won't be too long before we're doing whole genomes and many other things.
I didn't say anything about problems with their genetic testing (heck, I bought it myself), just with their marketing and interpretation. Those are the things that are now on pause.
This is exactly why the FDA is acting correctly here!
By "this" I meant "people not understanding the massive limitations in what 23andme does, likely due to their misleading and overhyped marketing material".
Rereading my post, I can see how that might not have come across as I originally intended.
Dig deep on the 23andme website and you'll find that they test for a few BRCA mutations, but not all. It's far from comprehensive, and it's not at all equivalent to a normal test that you would get from a doctor. From https://customercare.23andme.com/entries/23241132-Does-the-2... "The BRCA Cancer Mutations (Selected) report includes 3 selected BRCA mutations. The BRCA mutations covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes that can cause cancer."
I've seen several commenters here on HN making the same mistake as you. HN readers are generally smart and skeptical. If we aren't perceptive enough to see through the bullshit, how do you think the general public is going to fare?