23andMe is a personal genomics company in California that provides rapid genetic testing based on DNA microarray hybridization. You just spit into the collection tube, they extract DNA from your saliva and analyze more than a million genetic variants. 23andMe DNA microarray technology is based on the most advance science in genomics today and they are real pioneers to bring genomics to the people. I am one of the more than half a million people so far who had the advantage to be tested and has the privilege to look into the secret of my own personal genome.
23andMe received a warning letter from the FDA because they made some marketing mistakes. They have been marketing their products as “for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body”, the FDA warning letter says.
This is a false promise from 23andMe because their tests are based on association studies. Association studies determine if a certain trait or disease is associated with specific genetic variant. Association studies do not claim that certain genetic variant causes a trait or a disease. 23andMe tests more than one million genetic variants, single nucleotid polimorphism (SNP’s), but today there is no information available as what most of those SNP’s mean. Results for association studies are available only for 254 conditions as 23andMe claims. We know something about those 254 conditions, some statistical information about some possibilities. Association studies do not give direct genetic evidence about a genetic cause for a specific disease.
Here is the assessment for breast cancer BRCA-related genetic risk. Think of Angelina Jolie. I thought a half a year ago she was making me a favor and as a matter of fact for everyone in the genetic business. She was providing the entire industry with free good publicity. In my early phase of preparing for my blog I was enthusiastically talking about the famous Hollywood actress, who was making a serious health related decision based on genetic testing. Her test was based on sequencing both the BRCA-1 and BRCA-2 genes and the testing company was searching for every possible known variation. They determined that she had an 87% chance for developing breast cancer by the age of 70, plus she had a strong family history of breast cancer, which made her odds worse. Angelina Jolie is one of the most known celebrities in the world. Her decision was based on medical information. Her medical doctor prescribed the genetic test, her medical doctor received the test result, her medical doctor analyzed the data, and the medical doctor presented to Angeline what the genetic test meant. The cost of testing herself for two breast cancer genes was $7,000.
The quality of Angelina Jolie as a person is as good as the quality of a Ferrari in the automotive industry. The quality of the breast cancer genetic testing is a Porsche. The cost of a 23andMe test is only $99 which is much less than the $7,000 that Angelina paid. Think with a simple, pure, logical competitive sense of capitalism. The quality of the company 23andMe is like a Lamborghini Diablo with world class scientists and first in its class upper management, but in medical terms 23andMe genetic test is a toy for children, a nice present to give to family members for Christmas.
Also, it was a very good summer present for me. I loved reading the results and their specific health recommendations. I created a full blog analyzing my own personal genomics and real life experiences. I am no longer drinking on long international flights even if the boose is for free because I have an elevated risk for thromboembolism, blood clot formation in my lower legs if I just sleep 7-8 hours sitting, and the clot might get loose in my bloodstream. I eat healthier food, because I have an increased risk for getting fat or gaining weight based on my pleasure eating FTO gene, that is responsible for the regulation of my appetite and satiety. They have other recommendations that I love to read.
Ok, let’s say I don’t have that much of a risk for thromboembolism or the whole FTO theory for obesity and eating desire is questionable. Am I making a mistake to drink less alcohol or eat healthy food? No, it is for my benefit. I feel good about it. I feel good about myself, maybe because I am a genetic determinist, and also there are half a million other people out there who enjoy this information, for 99 dollars. Good for them. Good for us. And please, share with me all this information on my EpiGeneBook. It is unbelievable what people share on Facebook. Personal genomics information is at least based on cool science and it is fun to share. But all in all, would I make a serious life changing medical decision based on 23andMe genetic testing? No. Should anybody do that? Hell no. 23andMe is responsible for this kind of statement. They know exactly how much they can say about your genetic test results. 23andMe should say that their genetic testing is not for medical diagnostic purpose. 23andMe genetic tests are for research only, for pleasure only.
In my opening blog I said if you are sick, go to a doctor. You might have a genetic condition which has a diagnostic test approved for it by the FDA, do it. Make the health insurance provider pay for it and make your doctor decide what your treatment would be. Make health-life decisions based on direct medical, genetic facts, taking the advice of your doctor. If you are sick, you might not want to take the 23andMe genetic tests.
My recommendation to Mr. Alberto Gutierrez FDA Director: Follow the law and regulate 23andMe for making false statements, but please don’t take away my toy. Toys’R’Us would be liable to promise that children playing with their toys will acquire a PhD in science but they can claim, that some of their smart toys can sharpen children’s mind.
Tibor Gyuris
Personal Genomics Blogger
2013. November 26
“Knowledge is always good and certainly always better than ignorance.”–Sergey Brin
“Possideo genes ergo sum”—Anonymous Roman Philosopher
….can fruit fly choose sexual orientation….
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