Executive summary Breast cancer is detected by testing for a cancer antigen, CA153, that increases as cancer cells multiply. Inoviq Ltd is an Australian medical diagnostics company that has developed a breast cancer detection test that outperforms the incumbent CA153 test. According to the WHO, breast cancer is the most common cancer globally, with 2.3m new cases, 685k deaths and 7.8m survivors (5-year prevalence) in 2020. Breast cancers recur in roughly 10% of cases (up to 40% for triple negative cancers), necessitating regular monitoring of patients (four times annually for 2 years and once annually thereafter). The global breast cancer diagnostic market was valued at $4.2b in 2021. As at December 2023, Inoviq Ltd has a market capitalisation of AUD$60m. The science Cancer cells have a distinct feature of adding different sugar molecules to the proteins they produce, which sets them apart from normal cells. One such sugar molecule commonly found in cancer cells is Neu5GC. Inoviq has engineered a protein, called SubB2M, that preferentially binds to Neu5GC, enabling increased sensitivity and specificity in disease detection. SubB2M is a patented technology. The performance advantage Existing CA153 tests have inadequate sensitivity and specificity for early-stage detection and are commonly used as an adjunct to other diagnostic tests for monitoring. An independent clinical validation study revealed that SubB2M/CA15-3 demonstrated sensitivity and specificity of 81% and 93%, compared to 37% and 88% for Roche's approved CA15-3 test, respectively. The SubB2M test significantly reduces misdiagnoses with lower false positive (7%) and false negative (19%), compared to Roche's test (12% and 63%, respectively). The area under the curve (AUC) for Inoviq's test was 0.93, compared to 0.70 for the Roche test. 
According to the Principal of ResearchDx, "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 would be a game-changer for clinicians and clinical practice for screening of undiagnosed breast cancer and in monitoring diagnosed breast cancer." Commercialisation The SubB2M test will initially be released as a Laboratory Developed Test (LDT) with eventual FDA 510k/PMA as an In Vitro Diagnostic (IVD). As of December 2023, the company is conducting a cross-sectional monitoring study to demonstrate superior performance of the test for treatment response and/or disease recurrence over approved CA15-3 tests. This study is expected to be complete by the end of Q2 FY24, with the LDT expected to be market-ready by December 2023. Sources ASX Announcement Breast Cancer Diagnostics Market Size & Share Report 2030 (grandviewresearch.com) Cancer Today (iarc.fr) Comments are closed.
|