INOVIQ (ASX:IIQ) has announced progress in breast cancer diagnostics, completing a pivotal study for its “neuCA15-3” blood test.
The test is designed to detect breast cancer across all stages and major subtypes. It achieved 81% sensitivity (correctly identifying those with breast cancer) and 93% specificity (accurately excluding those without breast cancer).
INOVIQ is a biotech focused on tests and therapies for cancer. Earlier this week, it reported progress with its ovarian cancer test.
How does the test work?
CA15-3 is a substance in the blood linked to cancer. Other CA15-3 tests measure all forms of CA15-3, regardless of whether it’s from normal cells or cancer cells. However, INOVIQ uses a specially engineered protein called SubB2M, which binds to the Neu5Gc sugar commonly found on cancer cells. By targeting this cancer-specific sugar, the test can zero in on CA15-3 linked to cancer cells, making cancer tests (breast, ovarian, prostate, pancreatic and others) more accurate.
Traditional CA15-3 tests are used to monitor response to breast cancer treatment, but they have have inadequate sensitivity and specificity for screening.
The neuCA15-3 test is initially being developed as an improved monitoring test.
Key findings from the study
The disease specificity study validated neuCA15-3’s ability to distinguish breast cancer from non-cancer diseases.
When compared to a leading FDA-approved test, the neuCA15-3 test delivered better sensitivity and specificity.
For context, other CA15-3 tests have achieved sensitivity of around 60% in preoperative breast cancer, and specificity of 76% (in contrast with neuCA15-3’s 81% sensitivity and 93% specificity).
Next steps
INOVIQ plans to transfer the neuCA15-3 test to high-throughput diagnostic platforms, publish the findings in a peer-reviewed journal, and secure a US laboratory partner for commercialisation.
“This study is a critical milestone for the development of the neuCA15-3 breast cancer test,” said CEO Dr Leearne Hinch. “It demonstrated the test’s superior ability to detect breast cancer across all stages and key subtypes while distinguishing it from non-breast cancer conditions.”
The global breast cancer diagnostics market was valued at US$4.3b in 2022 and is expected to reach US$7.7b by 2030.
Shares in INOVIQ have risen 12% to 56 cents on the back of the announcement.