Posted: 9 February 2023
INOVIQ Limited is pleased to announce positive results from an independent retrospective case-control study to evaluate the performance of its SubB2M-CA15.3 breast cancer test across all stages of breast cancer.
CA15.3 is a tumour marker test that is commonly used in a clinical setting to monitor breast cancer treatment response and disease recurrence. By enhancing existing tumour marker tests with SubB2M, sensitivity, specificity and clinical utility are expected to be improved.
The objective of this 94-serum sample study was firstly, to establish that INOVIQ’s SubB2M-CA15.3 test effectively discriminates between breast cancer cases and control samples, and secondly, to compare the performance of the SubB2M-CA15.3 test against Roche’s Elecsys CA15.3 II test running in a clinical service laboratory. The data showed INOVIQ’s SubB2M-CA15.3 test clearly discriminated between breast cancer and healthy controls across all cancer stages, correctly identifying 73% (69/94) of all samples tested. When compared to Roche’s Elecsys CA15.3 II test, performed on the same set of samples, INOVIQ’s SubB2M-CA15.3 test displayed superior performance with:
- AUC2 of 0.81 vs 0.68;
- lower false positive rate (21% vs 29%); and
- lower false negative rate (31.3% vs 43.8%).
The overall performance of INOVIQ’s test was 69% sensitivity and 78% specificity for breast cancer across all stages, compared to 56% sensitivity and 71% specificity for the Roche test. Notably, INOVIQ’s test discriminated early-stage breast cancer (Stage I and II) from healthy controls, whereas the Roche test only discriminated stage IV cancer from controls.
