Inoviq’s breakthrough breast cancer test neuCA15-3 shows unparalleled accuracy

Inoviq Limited, an emerging leader in biotechnology, has announced a significant advancement in breast cancer detection. The company recently completed disease specificity testing for its neuCA15-3 test, which leverages its proprietary SubB2M technology. This innovative immunoassay, designed to detect Cancer Antigen 15-3 (CA15-3), has demonstrated exceptional sensitivity (81%) and specificity (93%) across all stages and types of breast cancer.

The study aimed to confirm that the CA15-3 test delivers accurate results for cancer detection while minimising false positives in non-cancer diseases. Serum samples from individuals with and without breast cancer were tested, alongside those with conditions such as endometriosis, rheumatoid arthritis, Crohn’s disease, and type II diabetes—ailments often associated with elevated CA15-3 levels. Results revealed that breast cancer patients exhibited CA15-3 concentrations five times higher than healthy individuals, while the test remained 97.4% negative for non-breast cancer cases, validating its specificity for cancer.

Further strengthening these findings, an independent accredited pathology laboratory conducted a comparative analysis using a leading FDA-approved CA15-3 test. Unlike the neuCA15-3 test, the comparator could not differentiate effectively between healthy individuals and non-cancer patients, highlighting the superior performance of Inoviq’s innovation in breast cancer detection.

Leearne Hinch, Chief Executive Officer of Inoviq Limited, noted that this achievement marks a critical step toward the test’s commercialisation in the United States, where it will initially be developed as a Laboratory Developed Test (LDT). Hinch emphasised the importance of transferring and optimising the test for compatibility with high-throughput diagnostic systems, enabling broader clinical adoption process.

Inoviq Chairman David Williams expressed optimism about the scalability of SubB2M technology, describing its potential to enhance other cancer biomarker tests, such as those for ovarian and prostate cancers. He stressed that the company’s long-term goal is to establish partnerships for leveraging SubB2M across a wide range of diagnostic applications.

The neuCA15-3 test is part of a broader strategy by Inoviq to address the global need for accurate, cost-effective solutions in breast cancer monitoring. According to the World Health Organization, breast cancer remains the most common cancer worldwide, with 2.3 million new cases annually. Despite the availability of serum tumour marker tests, including CA15-3, CA 27.29, and CEA, these options often fall short in sensitivity and specificity, particularly for early-stage breast cancer detection.

As part of the next phase, Inoviq plans to publish its findings in a peer-reviewed journal, transfer the assay to a high-throughput platform, and conduct clinical studies to support the adoption of neuCA15-3 in breast cancer monitoring and recurrence. The company also aims to collaborate with accredited US laboratories to streamline the test’s market entry.

With its innovative approach, Inoviq is poised to redefine breast cancer detection, addressing unmet clinical needs and offering new hope for millions of patients worldwide.