RT Book, Section
A1 McCarthy, Jeanette J.
A1 Mendelsohn, Bryce A.
SR Print(0)
ID 1134735324
T1 Regulation and Reimbursement
T2 Precision Medicine: A Guide to Genomics in Clinical Practice
YR 2016
FD 2016
PB McGraw-Hill Education
PP New York, NY
SN 9781259644139
LK accessmedicine.mhmedical.com/content.aspx?aid=1134735324
RD 2024/04/25
AB Regulatory  and  reimbursement  decisions  for  precision  medicine  tests  are  based  in  large  part  upon  a  body  of  evidence  around  three  performance  characteristics  of  the  test:  analytical  validity,  clinical  validity,  and  clinical  utility.  We  will  first  review  these  concepts  and  then  discuss  the  current  regulatory  and  reimbursement  environment  in  the  United  States.