INOVIQ (ASX:IIQ) announced progress in its SubB2M diagnostic program, completing a specificity study for its “neuCA15-3” breast cancer monitoring test.
The test was developed as an aid in monitoring breast cancer treatment response and recurrence. The test has been validated to be effective in monitoring breast cancer and to detect breast cancer in all stages, major types and subtypes with a sensitivity of 81% (correctly identifying breast cancer patients) and specificity by 93% (carefully excluding those without breast cancer).
INOVIQ is a biotechnology focused on cancer testing and therapies. Earlier this week, it reported progress with its ovarian cancer trial.
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 they come from normal or tumor cells. However, INOVIQ uses a specially designed protein called SubB2M, which binds to the Neu5Gc sugar commonly found on cancer cells. By targeting this cancer-specific sugar, the test can focus on CA15-3 bound to tumor 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 have inadequate sensitivity and specificity for screening.
The neuCA15-3 test was initially developed as an improved monitoring test.
Main results of the study
The disease specificity study validated the ability of neuCA15-3 to distinguish breast cancer from non-cancer diseases.
Compared to a leading FDA-approved test, the neuCA15-3 test provided improved sensitivity and specificity.
For context, other CA15-3 tests have achieved a sensitivity of approximately 60% in preoperative breast cancer and a specificity of 76% (in contrast to neuCA15-3’s 81% sensitivity and 93% specificity).
Next steps
INOVIQ plans to transition the neuCA15-3 test to high-throughput diagnostic platforms, publish the results in a peer-reviewed journal, and secure a U.S. laboratory partner for commercialization.
“This study represents a critical milestone in the development of the neuCA15-3 breast cancer test,” said Dr. Leearne Hinch, CEO. “It demonstrated the test’s superior ability to detect breast cancer at all stages and major subtypes, distinguishing it from conditions other than breast cancer.”
The global breast cancer diagnostics market was valued at $4.3 billion in 2022 and is expected to reach $7.7 billion by 2030.
INOVIQ shares rose 12% to 56 cents in the wake of the announcement.