Breast Cancer Test | Improved BC Monitoring
Breast Cancer Test | BC04
To evaluate the clinical performance of the SubB2M/CA15-3 test across all stages of Breast Cancer compared to healthy controls and compare the performance of the SubB2M/CA15-3 test to a leading approved CA15-3 test in the same samples in a clinical laboratory setting.
| Table 1: SubB2M/CA15-3 & Comparator CA15-3 Test Performance Summary
|Breast Cancer All Stages
|False Negative Rate
|False Positive Rate
|Positive Predictive Value
|Negative Predictive Value
SubB2M/CA15-3 breast cancer test provides more accurate detection of breast cancer across all stages, and significantly outperformed a leading approved CA15-3 test.
Figure 1: Test Sensitivity by Stage @95% Specificity
Breast Cancer Test | Data
Data from a 483-sample retrospective case control, clinical validation study demonstrated the SubB2M/ca15-3 breast cancer test significantly outperformed a leading approved CA15-3 test across all states of breast cancer1.
SubB2M/CA15-3 test provides more accurate detection of breast cancer across all cancer stages, demonstrating 81% sensitivity and 93% specificity, compared to a leading approved CA15-3 test2.
NEXT: Cross-sectional monitoring study to evaluate performance of SubB2M-CA15-3 test to aid monitoring of treatment response and/or disease recurrence.
1Study performed by ResearchDx under Master Services Agreement (ASX: 5/4/22); 2SubB2M Breast Cancer Test results (ASX: 27/6/23); 3A Receiver Operating Characteristic (ROC) curve is method of estimating the performance of a test to classify samples as diseased or healthy. The area under the ROC curve (AUC) represents how well the test can correctly discriminate between case and control samples; the higher the AUC, the better the test.