Table 1.

Biomarker scoring for six drugs according to [3]

Points to evaluate	Dabigatran	Ipilimumab	Gefitinib	Gefitinib*	Vilazodone	Latrepirdine	Semagacestat
1	5 [4]	3 [5]	5 [6,7]	5 [6-10]	3 [11]	-	5 [12,13]
2	5 [4]	1 [5]	3 [6,7,14]	4 [6,7,10,14]	1 [15]	-	5 [12,13]
3	3 [16,17]	5 [5]	3 [1]	5 [1]	1	-	3 [18,19]
4	3 [20,21]	2 [5]	5 [1]	5 [1,10,22]	1	-	0 [23]
5	1	5 [5]	5 [24,25]	5 [8,9]	5 [26,27]	-	1 [23]
6	10 [20,21]	4 [5]	10 [24,25]	10 [8-10,22,28]	6 [26,27]	-	0 [23]
7	4 [29]	5 [5]	4 [30]	5 [28,30]	1	-	1 [23]
8	3 [31]	4	4	5	1 [32]	-	5 [33,34]
9	3 [35]	4	4	5	1 [32]	-	4
10	5 [36]	5 [1,5]	5 [1]	5 [1]	5 [11]	-	4
Sum	42	38	48	54	25	0	0

*after the development of the pivotal biomarker (EGFR mutation status)

The leading biomarkers evaluated were: aPTT for dabigatran, immune related response criteria for ipilimumab, effects on tumor growth for gefitinib, tumor growth and mutation status of EGFR for gefitinib, Hamilton Rating scale for depression-17 for vilazodone, none for latrepirdine, and effects on amyloid plaques for semagacestat.

Points to evaluate:

1. Are animal or in vitro data available?

2. How many species have been tested positively?

3. Are the animal models enough to reflect human disease?

4. Is there corresponding clinical data?

5. Are human data available?

6. Human data classification (2x)

7. Does the biomarker represent a pivotal disease constituent?

8. What is the statistical predictability?

9. What is the accuracy or reproducibility of the assay?

10. How accessible is the specimen?