510k = FDA clearance for Class II device; CLIA = Clinical Laboratory Improvement Amendments (high-complexity tests) ; IVD = In Vitro Diagnostic; LDT = Laboratory Developed Test; 
1. https://gco.iarc.fr/today/home; Breast Cancer Diagnostics Market Size & Share Report 2030 (grandviewresearch.com); 3. Based on 4.5m tests pa @$150/test for BC monitoring in US, EU5 and AU; 4. Neu5Gc = the sialic acid, N-glycolylneuraminic acid

Study Objectives

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.

Study Outcomes

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.

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.

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.

Figure 1: Test Sensitivity by Stage @95% Specificity

1. SubB2M/CA15-3 clinical validation results (ASX: 27/6/23) ; 2. Breast cancer monitoring study results (ASX: 22/2/24); 3. HR+ = Hormone Receptor, HER2+ = Human Epidermal growth factor Receptor 2 (HER2), Triple-Negative Breast Cancer (TNBC)