• INOVIQ's SubB2M/CA15-3 breast cancer test detects all-stages of breast cancer with excellent accuracy (87%), sensitivity (81%) and specificity (93%)
• The results of a comprehensive 483-sample case-control study established that INOVIQ's SubB2M/CA15-3 blood test significantly outperformed a leading approved CA15-3 test, demonstrating an area under the curve (AUC) of 0.93 compared to 0.70
• INOVIQ is finalizing its planned breast cancer monitoring study and advancing discussions with potential partners and Key Opinion Leaders (KOL's) for its SubB2M platform and tests

CEO Dr Leearne Hinch said: "The outstanding results from this independent clinical validation study of our SubB2M breast cancer test represent a major milestone for INOVIQ. Our SubB2M/CA15-3 blood test detected all-stages of breast cancer with 81% sensitivity and 93% specificity, outperforming a leading CA15-3 test. These positive results support the commercial potential of our simple, cost-effective SubB2M/CA15-3 test for screening and monitoring of breast cancer.

INOVIQ intends to present these data and our development plans to potential partners and KOLs to advance commercial discussions for its SubB2M/CA15-3, SubB2M/CA125 and SubB2M multi-cancer tests."

Background to SubB2M technology and SubB2M/CA15-3 test

INOVIQ's disruptive SubB2M technology is an engineered protein that detects the pan-cancer biomarker Neu5Gc, found in multiple human cancers. SubB2M tests are designed to enhance the sensitivity, specificity and clinical utility of existing tumour marker tests routinely used for cancer detection and monitoring, such as CA15-3 for breast cancer, CA125 for ovarian cancer, PSA for prostate cancer and CA19.9 for pancreatic cancer.^[1] 

CA15-3 tumour marker tests are routinely used to monitor breast cancer treatment response and disease recurrence. However, existing CA15-3 tests have inadequate sensitivity and specificity for early-stage detection and are commonly used as an adjunct to other diagnostic tests for monitoring. The SubB2M/CA15-3 test is initially being developed as an improved monitoring test for breast cancer.

INOVIQ engaged US-based contract research organisation, ResearchDx, to undertake assay development and validation of its SubB2M tests (ASX: 5 April 2022). Positive results were previously reported from the analytical validation of the SubB2M/CA15-3 test, demonstrating 78% sensitivity and 80% specificity for detection of breast cancer (ASX: 8 February 2023). The SubB2M/CA15-3 test subsequently underwent further optimisation to improve sensitivity and specificity prior to commencing clinical validation.

SubB2M/CA15-3 test clinical validation study method, results and conclusion

The objectives of this 483-sample, case-control, clinical validation study were to: 1) evaluate the clinical performance of the SubB2M/CA15-3 test across all stages of breast cancer compared to healthy controls; and 2) to 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.

The results demonstrated that INOVIQ's SubB2M/CA15-3 breast cancer test provides more accurate detection of breast cancer across all stages. INOVIQ's test demonstrates overall sensitivity and specificity of 81% and 93%, compared to an approved CA15-3 test of 37% sensitivity and 88% specificity (Table 1). The SubB2M test significantly reduces misdiagnoses with lower false positive (7%) and false negative (19%) rates, in this sample set.

The study established that INOVIQ's SubB2M/CA15-3 blood test significantly outperformed a leading approved CA15-3 test. The area under the curve (AUC) for INOVIQ's test was 0.93, compared to the Comparator test of 0.70, indicating the superior diagnostic accuracy of the SubB2M test.

Analysis of test sensitivity at 95% specificity by breast cancer stage, demonstrates the superior performance of the SubB2M/CA15-3 test compared to a leading CA15-3 test for detection of breast cancer across all stages, in this sample set. The SubB2M/CA15-3 test's performance was confirmed through logistic regression analysis, and these data support its potential use for both screening and monitoring of breast cancer.

INOVIQ CSO, Dr Gregory Rice said: "In this large clinical validation study, the SubB2M/CA15-3 test clearly outperformed a leading CA15-3 test at all cut-off points tested. Its impressive performance makes it an ideal blood test for enhancing treatment response monitoring and enabling earlier detection of disease recurrence. Having completed rigorous analytical and clinical validation, the next step involves conducting disease monitoring studies and assessing the test's impact on clinical decision-making in collaboration with KOLs and potential partners in the United States."  

Dr Mathew Moore, Principal of ResearchDx, added: "These outstanding data clearly improve on existing CA15-3 tumour marker tests routinely used for monitoring breast cancer. The SubB2M/CA15-3 test detects all stages of breast cancer with high accuracy, which could be a game-changer for clinicians and clinical practice for screening of undiagnosed breast cancer and in monitoring diagnosed breast cancer."

SubB2M CA15-3 test and next development steps

INOVIQ's next step is to conduct a cross-sectional monitoring study to demonstrate the superior performance of the SubB2M/CA15-3 test for treatment response and/or disease recurrence over approved CA15-3 tests.

INOVIQ is working with ResearchDx and its clinical advisors to finalise the clinical validation plan. This clinical study is expected to complete by the end of Q2 FY24, with the test then expected to be market-ready.

Other SubB2M test development plans

INOVIQ is also progressing its development plans for the SubB2M/CA125 test for ovarian cancer. Samples have been sourced and assay development and analytical validation studies are expected to commence in H1 FY24 and complete within 6 months. Clinical validation of this test is now expected to complete in H2 FY24.

The research-stage SubB2M multi-cancer test (MCT) on the Nicoya ALTO™ SPR instrument is undergoing further evaluation, with data now expected to report in Q1 FY24. Additional opportunities for development of a potential SubB2M MCT for point-of-care testing on other instrument platforms are also being assessed internally and with potential partners.

Authorised by the Company Secretary, Mark Edwards.

ABOUT INOVIQ LTD

INOVIQ Ltd (ASX:IIQ) (INOVIQ) is developing and commercialising next-generation exosome solutions and precision diagnostics to improve the diagnosis and treatment of cancer and other diseases. The Company has commercialised the EXO-NET pan-exosome capture tool for research purposes and the hTERT test as an adjunct to urine cytology testing for bladder cancer. Our cancer diagnostic pipeline includes blood tests in development for earlier detection and monitoring of ovarian, breast and other cancers