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View Full Version : 23andme officially goes retail



Amerijoe
09-11-2016, 02:31 PM
23andme at Walgreens drug store. This morning's tv ad for 23andme mentions available at retail outlets.

can't_lurk_no_mo'
09-11-2016, 07:27 PM
This will sell a lot more kits, especially if they can get some good product placement. I'd say they'll be advertising from the health angle since it's Walgreens.

AnnieD
09-12-2016, 06:03 AM
While this catches me by surprise, as it doesn't seem that long ago that the FDA shut down the health reports over concerns that 23andMe's marketing recklessly side-stepped physicians,I applaud the move & hope that it's profitable. It sounds like 23andMe will start competing with self-test companies like Pathway Genomics that popped up on Walgreen's shelves back in 2010 before physician groups & other critics cried that it was TMI for average consumer.

Personally, I understand the concern over high-risk results causing excessive fear-mongering vs. low-risk results causing false alarms or missed diagnosis. However, I don't foresee the masses storming into Dr. offices for unnecessary or ineffective medical care based on a few genetic reports or totally neglecting further inquiry or self-monitoring. I can already get myself in a frenzy (& do rash things like order a vitamin deficiency test kit online) by googling health topics over the Internet. OTOH, however, Pathway Genomics apparently offered genetic counseling to customers and physician-reviewed lab results, expensive benefits that probably paid for themselves in increased credibility.

miiser
09-12-2016, 09:07 AM
While this catches me by surprise, as it doesn't seem that long ago that the FDA shut down the health reports over concerns that 23andMe's marketing recklessly side-stepped physicians,I applaud the move & hope that it's profitable. It sounds like 23andMe will start competing with self-test companies like Pathway Genomics that popped up on Walgreen's shelves back in 2010 before physician groups & other critics cried that it was TMI for average consumer.

Personally, I understand the concern over high-risk results causing excessive fear-mongering vs. low-risk results causing false alarms or missed diagnosis. However, I don't foresee the masses storming into Dr. offices for unnecessary or ineffective medical care based on a few genetic reports or totally neglecting further inquiry or self-monitoring. I can already get myself in a frenzy (& do rash things like order a vitamin deficiency test kit online) by googling health topics over the Internet. OTOH, however, Pathway Genomics apparently offered genetic counseling to customers and physician-reviewed lab results, expensive benefits that probably paid for themselves in increased credibility.

I have experience developing medical devices and dealing with the FDA, so I can speak to the FDA requirements.

Just to clarify what happened with 23andMe - 23andMe wasn't shut down because the FDA had a problem with their product. 23andMe were temporarily shut down simply because they hadn't gone through the process of having the FDA declare that their product is okay for marketing. The FDA has a process that medical products are required to go through before marketing. 23andMe hadn't gone through any of that required process.

Any product which claims to provide some sort of medical testing or treatment is required to be cleared by the FDA. Once the FDA reviews the product, they decide how to classify it. At the lowest classification, they basically just say "okay, you're fine as is, but just put some official standardized labeling on the product to clarify how the product should and should not be used". At higher classifications, the FDA requires all sorts of device testing, extensive quality controls, validations, and animal and human clinical trials to prove that the product is safe and effective.

23andMe got the easiest path once they had gone through the formal FDA process. The FDA basically just made them put some labeling on it and clarify that the patient should not undergo any medical treatment based solely on the DNA test. But the FDA also made it clear that they were okay with the product being sold for its intended purpose.

I think the high profile Angelina Jolie case raised some alarm bells for the FDA, bringing it to their attention and causing some concern, making them realize that they needed to address the industry before large numbers of consumers started going to their doctors demanding preemptive organ removal. I've met enough fools in my life to believe that this is a legitimate concern by the FDA.

But the FDA doesn't have any problem with the product. It was more just a matter of nipping it in the bud so that it would not become a problem.

Also, 23andMe having already gone through the process makes it easier for subsequent companies to offer similar products, since the product type has now been classified and had some standards established. Sellers just need to go through the process of submitting a formal request to the FDA that says: here's what we plan to sell, marketed for this specific usage, and here's the labeling we plan to use.

leonardo
09-12-2016, 10:42 AM
23andme at Walgreens drug store. This morning's tv ad for 23andme mentions available at retail outlets.

Is the cost on the shelf, the same as online?

Ann Turner
09-12-2016, 03:22 PM
Any product which claims to provide some sort of medical testing or treatment is required to be cleared by the FDA. Once the FDA reviews the product, they decide how to classify it. At the lowest classification, they basically just say "okay, you're fine as is, but just put some official standardized labeling on the product to clarify how the product should and should not be used". At higher classifications, the FDA requires all sorts of device testing, extensive quality controls, validations, and animal and human clinical trials to prove that the product is safe and effective.

23andMe got the easiest path once they had gone through the formal FDA process. The FDA basically just made them put some labeling on it and clarify that the patient should not undergo any medical treatment based solely on the DNA test. But the FDA also made it clear that they were okay with the product being sold for its intended purpose.
.

My understanding is that it was considerably more complicated than that. 23andMe already had plenty of explanations and disclaimers. For instance, 23andMe had to demonstrate that base calls from a chip corresponded to other testing methods, that customers could answer 90% of questions after reading a report, and so forth.

Disclosure: I have a consulting arrangement with 23andMe, but I'm not involved with the health side of things.

Amerijoe
09-12-2016, 10:53 PM
Here is the offer at CVS.

http://www.cvs.com/shop/home-health-care/home-tests/parental-dna-gender-tests/23andme-personal-genetic-service-saliva-collection-kit-prodid-168385

miiser
09-13-2016, 12:26 AM
My understanding is that it was considerably more complicated than that. 23andMe already had plenty of explanations and disclaimers. For instance, 23andMe had to demonstrate that base calls from a chip corresponded to other testing methods, that customers could answer 90% of questions after reading a report, and so forth.

Disclosure: I have a consulting arrangement with 23andMe, but I'm not involved with the health side of things.

It's more complicated than what I wrote in my first comment. But my main point was that the FDA did not have a problem with the product. The FDA had a problem with 23andMe not following the FDA regulatory process.

23andMe are no longer marketing it as a medical diagnostic tool, as they did before the FDA action.

What 23andMe are selling now is mostly an unregulated product, with a few scattered tests included that are FDA approved for medical testing. They divide the test into 4 sections: carrier status, ancestry, wellness, and traits. Only the "carrier status" reports fall under FDA regulation. The rest gets a free pass. And they put a disclaimer on the carrier status report that says, "The tests are not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future." They no longer have the same sort of medical risk reports that they had before the FDA action.

DNA tests that are marketed for the purpose of medical testing have to prove accuracy and clinical significance. 23andMe basically decided not to market the main portion of their product for medical purposes, which allows them to sell most of their product without satisfying such requirements. But they've been gradually adding medical reports back in for specific tests that have gotten FDA approval. And I expect they will continue adding other tests over time.

leonardo
09-13-2016, 01:16 AM
Here is the offer at CVS.

http://www.cvs.com/shop/home-health-care/home-tests/parental-dna-gender-tests/23andme-personal-genetic-service-saliva-collection-kit-prodid-168385

So, it's essential the same price.

MacUalraig
09-13-2016, 07:09 AM
23andme at Walgreens drug store. This morning's tv ad for 23andme mentions available at retail outlets.

It has been on sale in the UK chain Superdrug for a couple of years.

http://www.superdrug.com/23andme

tippy
09-13-2016, 09:57 AM
I feel like the price should be lower now because they've taken out most of the semi-decent tools. At this stage it's almost like you're paying for the raw data and some piss poor analysis that you can improve by going to wegene or dna.land. Maybe they should just offer a raw data service or maybe they can work on their offerings a bit more? It's sad that genetics have come a long way since 2009 and yet 23andme's service has gotten a lot worse. Back then, the full price was 600$ and you would get value for money a lot more easily, now it's 100 bucks or so and it doesn't feel like it's worth it to me.

shazou
09-15-2016, 10:27 AM
I heard that they also sell them at Target now. I've been meaning to get my uncle a kit for some time now, but Ftdna's $79 price tag for Family-Finder is just too cheap to pass by. Ftdna also tests for more SNPs than the current 23andme chip.

tippy
09-15-2016, 10:38 AM
23andme sent me an email today saying they are upping their UK price by 50 on September 28. No explanation as to why. I think next kit I get will be for ftdna.

MacUalraig
09-26-2016, 12:29 PM
I've been toying with getting into their comparison database for some time now but not sure I can rustle up the cash before the price hike in 3 days time. Baffling that their prices are heading up instead of down especially since you can run AncestryDNA raw data through Promethease.

MacUalraig
09-26-2016, 12:31 PM
23andme sent me an email today saying they are upping their UK price by 50 on September 28. No explanation as to why. I think next kit I get will be for ftdna.

The UK price is increasing from UKP125 to UKP149, not sure where you got that figure from.
" 125

shipping included
Price increasing to 149 on 29 Sept."

https://www.23andme.com/en-gb/?utm_source=google&utm_medium=cpc&utm_campaign=GB_Search-Branded&utm_term=uk_onepager&utm_content=23c_Search_Paid_Brand&gclid=CMTPpe-Crc8CFSEz0wodOW0HNA&dclid=CMjN0O-Crc8CFUuw2wodgF0P8A

tippy
09-26-2016, 12:52 PM
It was 99 a few months ago - but good point. Still, a large price increase without an explanation is not something I'm a fan of.

ArmandoR1b
09-26-2016, 01:17 PM
I received an email from 23andme on Sep 23 that has this at the bottom:


Look for 23andMe DNA kits on sale now at CVS stores and select Target stores nationwide.

I put select in bold. It's missing from the CVS portion of the message.

23andme also has the Ancestry only test for $99 in the U.S. https://www.23andme.com/dna-ancestry/