. 2013 Apr;33(3):333–342. doi: 10.1177/0272989X12452341

Table 2.

Reimbursement Situations Requiring Different Applications of the Assessment Framework

Reimbursement Situation	Biomarker^a	Test	Drug
Prototype situation (see Additional file 1)	Probable new marker	New reimbursement application	New reimbursement application
Situation I	Valid marker	Currently reimbursed	New reimbursement application
Situation II	Valid marker	New reimbursement application	Currently reimbursed
Situation III	Valid marker	New reimbursement application	New reimbursement application
Situation IV	Group of markers	Currently reimbursed ± new reimbursement application	Currently reimbursed ± new reimbursement application

^a.

The Food and Drug Administration FDA categorizes biomarkers according to “probable” and “valid.”^24,25