Kristine Ashcraft, Medical Affairs Director, Pharmacogenomics, Invitae
0:00 A tipping point
4:00 How to deal with the Rx/Dx conflict?
5:39 Does the industry want help from the FDA?
12:29 Are you happy with AMP and CPIC - is this working?
18:04 Ideally we all have PGx testing once in our life - at birth
23:49 Short horizon for payers a big obstacle
28:46 Pharmacists the ideal educators for PGx
Pharmacogenomic testing, or PGx, is considered low-hanging fruit, a no-brainer for the application of genetic testing in the clinic. And some may think it is small fruit. Not so, says today’s guest, Kristine Ashcraft.
"Currently we lose a life every two minutes in the United States to non-optimized medications,” says Kristine in today’s show. She has spent over twenty years working to see pharmacogenomic testing adopted into standard-of-care medicine. Kristine serves today as the Medical Affairs Director for PGx at the genetic testing company Invitae.
“In 2016, we spent $528 billion on non-optimized medications. That is more than we spend on the drugs themselves or on any chronic disease. Pharmacogenomics will not solve that on its own, but it is a major piece we do not consider.”
There are some big questions here. The FDA has not regulated genetic testing, for the most part. Has this been a hindrance to the adoption of PGx into medicine? Does the industry want the FDA to take a larger role? There are some informal regulatory groups, such as AMP and CPIC putting out guidance. Is Kristine happy with the system as it currently is?
Let’s take it out to you the listener. Have you been pharmacogenomically tested? Why or why not? When or how does one decide to be tested?
Kristine has some ideas. And Invitae, who recently bought her company YouScript, is the place where the rubber meets the road in genetic testing. Are we at the tipping point for PGx?