Posted: 5 December 2024
INOVIQ Limited (ASX:IIQ or INOVIQ) is pleased to announce the successful completion of disease specificity testing for breast cancer. The INOVIQ blood test is a simple, accurate and affordable immunoassay developed using a monoclonal antibody, widely used by diagnostic companies, combined with INOVIQ’s SubB2M detection reagent. The hybrid test specifically detects CA15-3 produced by cancer cells, improving cancer detection and potentially reducing false positives.
The test has now been analytically and clinically validated to detect breast cancer across all stages (81% sensitivity and 93% specificity), key breast cancer types and subtypes. Importantly, the test is effective for breast cancer monitoring.
The purpose of this study was to show that the neuCA15-3 test was positive and specific for cancer and had low false positives for non-cancer diseases. CA15-3 levels were measured in serum samples obtained from healthy individuals and patients with breast cancer or other non-cancer diseases where CA15-3 could be elevated, including endometriosis, rheumatoid arthritis, Crohn’s disease and type II diabetes. The test showed positive results for breast cancer, with the average CA15-3 concentration being five-fold greater than that observed in healthy individuals. The results were negative for 97.4% of non-breast cancer samples, confirming the specificity for breast cancer.
The same samples were also tested by an independent accredited pathology laboratory using a leading FDA-approved comparator CA15-3 test. Average CA15-3 concentrations were not significantly different between healthy and non-breast cancer patients for the comparator, indicating the superiority of the INOVIQ test.
CEO Leearne Hinch said: “The test is being developed as an LDT for the US market initially. Demonstrating the specificity of neuCA15-3 for breast cancer detection completes another component of the test validation. The next step towards commercialising the neuCA15-3 test is to transfer and optimise the test on a system compatible with high-throughput commercial diagnostic instruments.”
Chairman David Williams added: “The aim is to demonstrate that our SubB2M technology can be used as a detection reagent to enhance the performance of multiple existing cancer biomarker tests, including CA125, HE4, PSA and others.”
The next steps to commercialise the test include:
- Publication of a scientific paper on the neuCA15-3 test in a peer-reviewed journal to support partnering discussions;
- Transferring the test to an assay for implementation on a high-throughput instrument platform;
- Undertaking an in-clinic Breast Cancer monitoring study to support clinical adoption of the test; and
- Securing an accredited laboratory partner in the US for commercialisation of the test as a Laboratory Developed Test.
