INOVIQ (ASX:IIQ) has announced progress in its SubB2M diagnostic program, completing a specificity study for the “neuCA15-3” breast cancer monitoring test.
The test is being developed as an aid in monitoring breast cancer treatment response and recurrence. The test has been validated to be effective for breast cancer monitoring and to detect breast cancer across all stages, major types and subtypes with 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.
