INOVIQ Exosome Diagnostic Solutions
SubB2M/CA15-3 Test: data and plans
Clinical validation study | completed
Retrospective, case-control, clinical validation study in 483-samples
demonstrated SubB2M/CA15-3 test detected breast cancer across
Sall stages with high accuracy (AUC 0.93, 81% sensitivity and 93%
☐ specificity) and outperformed a leading approved CA15-3 test¹
biomarker concentration
For personal use only
Breast Cancer monitoring study | commenced
2-phase monitoring study in over 200-samples to evaluate
performance of SubB2M/CA15-3 test as an aid for monitoring
treatment response and/or disease recurrence compared to
approved CA15-3 test
Data expected Dec-23
SubB2M/CA15-3 and comparator CA15-3 test
performance summary
Breast Cancer All Stages
AUC
sensitivity
specificity
SubB2M
Comparator
0.93
0.70
81%
37%
93%
88%
false negative rate
19%
63%
false positive rate
7%
12%
positive predictive value
92%
75%
negative predictive value
83%
58%
overall accuracy
87%
63%
Test Sensitivity by stage @95% Specificity
100%
79%
80%
76%
72%
71%
64%
60%
40%
24%
23%
17%
18%
20%
18%
primary treatment
recurrence & treatment
tumor growth
treatment response
treatment response
0%
Stage I
Stage II
Stage III
Comparator
SubB2M
Stage IV
All Stages
10
1. SubB2M/CA15-3 clinical validation results (ASX: 27/6/23)
Breast cancer (n=241: 1=75, II=72, 3=72, III=72, IV = 22) and healthy controls (n=242)
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