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To quote: "Requiring that such tests demonstrate clinical "utility" could pose a particular problem if applied to 23andMe: The company has admitted its tests are not medically useful, as they represent preliminary findings, and so are merely for educational purposes."
Well, what have we here! So much money and they did not get their lawyers to do a simple fact check?
Demonstrating clinical utility could be a problem for a genetics test company?
Of course, all that really needs to happen is for Sergei to take a plane to Sacramento and convince people that demanding utilities in products is an absurdity:
"Our family has a tradition of creating half-functional products that we like to then display as the 'next best thing'.
Demanding fully functional or otherwise useful products interferes with our ideals to do business with no meaning, purpose or use and severely inhibits our ability to charge people for it!
If you don't stop making such demands immediately, we will buy California and sell it to someone else."
And so the story goes...
In reality though, if you look past the silliness, I do not have any sympathies for 23andme or Navigenics. Sailing on funds available through randomness or gullible Venture Capitalists, these firms set off to "create genetic profiles" that are "preliminary results only" and what not.
I am also not ga-ga over Navigenics "going through a doctor".
Its not like everyone with a Medical Degree has been sifted through the sieves of ethical practice.
We have barely understood that we have about 30,000 odd (or 40,000 odd was it?) genes in the human body.
We still theorize and struggle to explain why, our genetic scheme is only 1 - 2% different from that of the chimpanzee and that somehow fabulously makes us superior ( a very subjective opinion) as animals.
We have just finished realizing that our mitochondrial DNA - in statistical summary all of ours, meaning the 6 billion of us, almost shared the same mother once - meaning our entire race was nearly destroyed.
All this means one thing: we need to understand a lot more of the nuances of genetic interactions and how they are turned on and off before running around with a CD of our genetic code. Of course, whenever SNPs lead to disease, we can start working on those in the near future, but for most other complex genetic interactions, data provided by companies like 23andme would be useless.
Yes, indeed, it would be a great idea to cull genetic data from thousands of human beings. It would allow for statistical correlations (if we believe in statistics, that is) and eventually solid proof.
However, I have some serious problems with companies that want to charge people for things even they consider to be useless.
It is also an important lesson for entrepreneurs.
Sometimes funding is not enough.
Sometimes funding itself can make you shortsighted and lead you down the wrong path.
What 23andme or Navigenics have failed in doing will be a great stepping stone for the next company that comes in:
1. Research, research, research. Clearly understand what you are selling, understand who is buying and what they want and why the want it. Are they buying something because they want it, need it, or think they need it (like the practically useless ipods and iphones)?
2. Understand national, international and rather more importantly local regulations - especially if "local" happens to be California.
But don't stop there. Just because something is not being regulated right now does not mean you can run away with anything (or precisely, that something). States and Nations often start regulating an industry in the wake of new practices. Of course, most of this is driven by fear, sometimes unfounded, but you need to spend at least a little time thinking about this, especially when you are doing something "groundbreaking".
3. Be wary of where your funding comes from. While it is often harked that you need supportive investors, you also need independent investors who need to judge if your idea makes for an actual sale-able product or service.
4. Don't name something "educational" (refer back to the quote about 23andme) unless it is actually educational. Yes, genetic testing can be educational. But how can it be educational to potentially gullible customers who paid for something useless?
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