Home DNA test kits


by Greg Bernhardt
Tags: home, kits, test
Monique
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#19
Jan30-12, 11:46 AM
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Quote Quote by Borek View Post
Be ready for some surprises.

The more DNA testing, the more divorces.
I was doing genetic testing a few years ago in the States, of families volunteering to participate in a scientific study. I sometimes ran into families where it was clear that the child must've been conceived by another man than the listed father. I always wondered whether any of the parents knew that was the case
Greg Bernhardt
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Jan31-12, 10:46 AM
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I ended up going for it! Just sent in my test tube of spit :) I'll report back in a few weeks with a review!
Ryan_m_b
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Jan31-12, 11:25 AM
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Quote Quote by Greg Bernhardt View Post
I ended up going for it! Just sent in my test tube of spit :) I'll report back in a few weeks with a review!
Please note we don't provide diagnoses here

In all seriousness it will be interesting to see what you find out, in particular what the company highlights.
lisab
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Nov26-13, 07:17 PM
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Interesting development about 23andme:

http://www.bbc.co.uk/news/technology-25100878

The US Food and Drug Administration has imposed a ban on a company offering personal genetic screening to the general public.

Google-backed 23andme has been ordered to "immediately discontinue" selling its saliva-collection tests after failing to provide information to back its marketing claims.

...

In a public letter the FDA said that 23andme had not supplied this information, despite increasing its marketing campaign and the scope of its tests.

"FDA is concerned about the public health consequences of inaccurate results from the PGS device - the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work," said Alberto Gutierrez, director of the FDA's centre for devices and radiological health, in a letter to the company.

"Patients relying on such tests may begin to self-manage their treatment through dose changes or even abandon certain therapies depending on the outcome of the assessment," he added.
While this certainly does have a "nanny-state" smell to it which I don't like, I see FDA's point. If the people ordering this test don't know how to interpret it, and they are making medical decisions with the data, that could be a problem. Or if they don't have enough relevant information to correctly interpret it due to marketing, that could be borderline fraud (e.g. if the company isn't releasing information because it would negatively affect sales).

Sticky problem. I wonder what 23andme is going to do about this?
edward
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Nov26-13, 09:49 PM
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It may go deeper than just a "Nanny State" situation.

The astigen-1 gene appears to be involved in muscle damage caused by statins. Statins are a multi- billion dollar industry.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2735363/

I have read a number of articles about people who have quit taking statins and headed to alternative medicine sources. The link below is from 23andme and describes one patient's experience.

But over the last few years, Richard noticed he was experiencing muscle problems. His doctor didn’t seem too worried, so at first Richard didn’t push it.

But all that changed when Richard took the 23andMe test last summer. His results at once surprised him and made sense. According to his 23andMe report he was at risk for developing muscle myopathy due to the use of statins.

23and me has a good read on a sidebar about not stopping meds because of anything found in the genetic tests.

http://blog.23andme.com/23andme-cust...ep-on-pushing/
berkeman
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Nov26-13, 10:22 PM
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My take-away is that Greg never revealed the results of his spit test...
Pythagorean
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Dec1-13, 02:38 PM
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"But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public."

http://www.scientificamerican.com/ar...or-reasons-fda
Greg Bernhardt
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Dec1-13, 05:01 PM
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Here was the email sent to me

Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

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.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe


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