1. Genetic Medicine
  2. The FDA, 2c19 and the

The FDA, 2c19 and the ACC

Posted on by

Did anyone see the FDA issuance of the better warning that as many as 14% of patients will not benefit from Plavix/Clopidogrel?

Did anyone see the cold shower being poured on by the press and the cardiologists?

Christopher Cannon Assoc. Prof at Harvard says:
The ACC will need to develop protocols, "Thus a real conundrum"

He then says "I expect mass confusion in response to this FDA warning"

Well Chris, It's not as if we haven't been shouting from the rooftops about this for over a year now.......

"The test costs about 500 USD according to Courtney Harper PhD, Director of the FDAs division of chemistry and toxicology devices. But cost isn't the only issue."

Which BTW is false 23andME is cheaper......But wait, isn't that medicine?

"The time to get a result varies. It may be a few hours to a day or two, or other labs may take a few weeks"

This is absolutely true. It takes me 3 weeks for a test from Quest. I am certain that there has to be some lab to do it quicker.......

BUT, the FDA has only approved AmpliChip for this testing.....

This sounds to me like the FDA needs to approve some kits and PDQ with the ACC meeting coming up like,

My guess

1. The ACC will address and release its prelim algorithm

2. The ACC conference will have even further data regarding this released.

3. The last step is to FDA in some kits to do this test, quicker and more standardized.

We need a company that can direct us to

So the question, why all the cold water on this killer app? Well, because it is getting lumped in with DTC genomics, which is feeling a backlash from hype and failed promises. Or trying to play medicine.
As well as a flat disregard for medicine. So when the press and the healthcare providers are against you, you can feel it.

But this is what I have been frustrated about all along. I saw this coming. Doctors blowing off PGx thinking it is SNPChip Hype. Journalists pouncing on overpromising and intellectually dishonest DTC Genomics companies.....

This is why I was so mad about the blimp.

When something really awesome comes around, people are burned out from Open Bars......

The Sherpa Says: Let's really do this. Genomics and PGx IS medicine. Let's say it proud, Let's ay it loud. Quit screwing around to avoid regs. Let's how the world how we can use this to help mankind!

Related Posts

Comments are closed.


  1. Genetic Medicine
  2. The FDA, 2c19 and the