WHAT STRATEGY FOR A NEW US TEST? FDA KIT APPROVAL, OR THE CLIA ROUTE? I have seen some phenomenal strategic errors in this area (names withheld); the best blooper was a set of tests that took a decade and close to 100 M USD in the FDA KIT approval process. This same set of tests would have taken only a matter of months and a few thousand dollars to launch in a CLIA Approved reference lab. If you want an OTC test, there may be reasons to go the FDA route, but rarely does it make sense. Don’t become another case study of a flawed strategy!
linkedin post 2022-06-29 05:12:48
Nigel Fleming
September 21, 2022