INOVIQ (ASX:IIQ) has successfully completed 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.
“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,” CEO, Leearne Hinch, said.
“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.”
