No more 23andMe testing in this household!

 

 

I have mentioned this several times in classes in recent weeks, but now it is time to put a more public face, uh, lipstick on this pig. If you are in the DNA testing marketplace for a DNA test right now my best advice is "DO NOT" do any genetic DNA testing at the company 23and Me. They have gone completely off the deep end in regards to those of us who are interested in genetic genealogy. Quite frankly I have never seen anything quite like it.

 

But hey, don't take my word for it. Roberta Estes on her DNAeXplained blog does a much better job at this point of explaining the issues than I would, but everything she mentioned in her post I have experienced first hand.

 

So if you have been thinking about testing at 23endMe for genetic genealogy purposes, be sure to read Roberta's comments in her Closing Up Shop at 23andMe and the Trap post.

 

Caveat emptor!

 

Our 23andMe DNA test results are in! And our impressions of their service . . .

Yesterday, I got back the results of my son's atDNA test. It is my first experience with this genetic genealogy testing company. I have tested in the past at Ancestry and FTDNA. And in my opinion of 23andMe - what an absolute utter mess.

The site is not user friendly (very difficult to navigate), the genetic tools, especially the chromosome browser, if that is what they call it, is non-standard and it is darn near useless.

They have loaded their plate up for all this health stuff and turned away from the genetic genealogy part of DNA testing. To add insult to injury it looks like they may have hired some of Ancestry's programmers to make their site real pretty, but like Ancestry and their "new site" the trade off is it is non-functional as a working DNA testing site (tongue firmly planted in cheek).

This experience has been a huge disappointment and as a genetic genealogy instructor I will make sure to let my students know not to utilize this service if they are interested in doing real genetic genealogy testing.

Bottom line: I immediately took his raw data and uploaded it to GedMatch (will also populate his test to FTDNA), and will wash my hands of this site, their tests, tools and company. For something that I have heard others rave about in the past, the 23andMe of today pretty much sucks and is a huge disappointment IMHO.

More DNA Testing in the VH Household

Well, surprise, surprise, I just ordered another DNA test kit. As most my students know I am eaten up by all this DNA stuff.  More about that kit in a minute.

So let's review what we have here. I started things when I ordered my first test, a 37-marker Y DNA test in January 2007 from FTDNA. I later upgraded that to a 67-marker Y-DNA test at FTDNA in Feb 2012.

In June 2012 I ordered and took a HSV1 mtDNA test from FTDNA.

In the meantime Gayle ordered and took a HSV2 mtDNA test in Feb 2012. In April 2012 we had Gayle's 2nd cousin take a 37-marker Y-DNA at FTDNA. Three months later we had his nephew also take a 37-marker test to verify and support the test taken by Gayle's cousin.

In May 2012, I was honored to be one of the original AncestryDNA autosomal Beta testers. On the heels of my test I had Gayle also take an AncestryDNA autosomal test. When AncestryDNA test raw results were finally released for download in June 2013 I sent both Gayle and my results to FTDNA and their atDNA database (much cheaper than taking two more test at their site).

In short order I also had my Dad, Mother and my Dad's 1st Cousin test at Ancestry and Gayle had her 2nd cousin also take an AncestryDNA test. All those results were also uploaded to GEDMatch (another large database with a chromosome browser capability).

So I admit that I have been a very busy guy managing all these test, but recently got a nifty great idea. Since neither Gayle or I have tested at 23andMe, the third major atDNA test site/database, we are going to have our son test there to get our DNA in their database with only one test for $99. Of course, I will upload his results to GEDMatch and phase his test with ours to see who gave him the most DNA.

That will get our autosomal DNA across all three major atDNA databases. So I hope that before my Fall DNA class a TCCC is over, I can provide a report to my students on how our 23andMe experience has been.

All this testing has been a wonderful tool in genealogy research. Some brick walls have fallen, leads have been pursued, and ancestral paper research lines have verified.  We maximized our testing by doing our initial test at Ancestry and uploading results to FTDNA and GEDMatch. We have truly gotten the most bang for the buck.

It has been a lot of fun working with our DNA test results and everyday is a new adventure thanks to it our genetic genealogy research.

If you have not tested and you are working on your family history, you are missing the boat. I especially encourage those who have parents living (or in their place siblings of those parents) to test them as well and soon before they are gone. You don't want to lose that precious resource and family genealogy record.

Bottom line, each of us has a genetic genealogy history book inside us and now we have the ability to read that book. It is time for you to turn those pages and discover your family history.

FDA Tells Google-Backed 23andMe to Halt DNA Test Service

23andMe Inc., the Google Inc.-backed DNA analysis company was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.”

23andMe is led by Anne Wojcicki, who co-founded the company in 2006 and recently separated from her husband, Google co-founder Sergey Brin. Google has invested millions of dollars in the company in recent years.

The 23andMe $99 Saliva Collection Kit and Personal Genome Service, or PGS, tells users whether they carry a disease, are at risk of a disease and would respond to a drug. Most of the uses fall into the category of a medical device and require Food and Drug Administration approval, the agency told the Mountain View, California-based company in a Nov. 22 letter made public yesterday.

Alberto Gutierrez, director of the FDA’s Center for Devices and Radiological Health, said in a letter to the company made public on Monday that 23andMe had failed to address concerns raised on multiple occasions since the agency began working with it on compliance in July 2009.

“FDA is concerned about the public health consequences of inaccurate results from the PGS device,” the agency said today. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”

“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment,” Gutierrez wrote.

The FDA said that while 23andMe had initiated new marketing campaigns that show how it plans to expand the uses of PGS, it had failed to provide information that the FDA requested multiple times. The FDA said it has had “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications” with 23andMe to discuss how to get the company to comply with its recommendations.

“However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions,” Gutierrez wrote.

23andMe is one of many companies to offer at-home genetic testing; in September it reported that its database had reached 400,000 people. Scientists have raised questions about the accuracy of the tests, and in May 2011 a Dutch study claimed the tests were inaccurate and offered little to no benefit to consumers.

Blog Editor Note: I have had several emails regarding this story and it has nothing to do with the genetic genealogy test we take to study our family history. This is about the personalized health DNA test that 23andMe (and only 23andMe) has been advertising recently for $99. Scientist claim that these personalized health tests that screen thousands of genes for versions that influence disease are inaccurate and offer little, if any, benefit to consumers. This part of the DNA story has been out there for several years now. As I see things now not to worry about the genetic testing that we have taken as genealogists. This has NOTHING to do with that unless you did your genetic test at 23andMe and that would only be impacted if the company shuts down.

There is a very interesting Forbes article with background on all this online at http://www.forbes.com/sites/matthewherper/2013/11/25/23andstupid-is-23andme-self-destructing/

Finally, here is an update posted yesterday on the 23andMe blog:

An Update Regarding The FDA’s Letter to 23andMe
         Published by Anne Wojcicki, co-owner of 23and Me.

23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives.

It is absolutely critical that our consumers get high quality genetic data that they can trust.   We have worked extensively with our lab partner to make sure that the results we return are accurate.  We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.
In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.

In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.
This is new territory for both for 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.

I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to better decisions and healthier lives — a goal that all of us share.

We will provide updates as they become available.