Posted: 1 May 2024
INOVIQ Limited (ASX:IIQ or INOVIQ) is pleased to announce the successful completion of an analytical validation study for its blood test for ovarian cancer. Overall, the test correctly identified 85% of all samples tested (76% of the cancer samples and 94% of the cancer free samples).
The blood test is a simple, accurate and affordable combination immunoassay developed using both a CA125 monoclonal antibody (used by leading diagnostic companies) combined with our SubB2M detection reagent. The addition of SubB2M ensures that the test only detects CA125 that is produced by cancer cells, resulting in improved specificity for cancer and potentially a reduced number of false positive test results.
The SubB2M/CA125 test has been analytically validated to have:
- Excellent reproducibility with less than 5% variability within assays and less than 10% variability between assays;
- Acceptable Limit of Quantitation of less than 4 Units of CA125 per ml of serum;
- High overall accuracy in 334 sample study with sensitivity of 76% and specificity of 94% for detection of ovarian cancer; and
- Equivalence to a leading CA125 test for detection of ovarian cancer (see graph).
CEO Leearne Hinch said: “With analytical validation complete, we want to refine our test to see if we can further improve the test performance before moving to clinical validation.”
Chairman David Williams said: “INOVIQ is seeking to demonstrate our SubB2M technology can be a superior detection reagent to improve the performance of multiple cancer biomarker tests. This will showcase the commercial potential of SubB2M for multiple cancers.”
