Innovic (ASX:IIQ) announced advances in its SubB2M diagnostic program and completed specificity studies for its “neuCA15-3” breast cancer monitoring test.

This test is being developed to monitor treatment response and recurrence of breast cancer. This test is effective in monitoring breast cancer and detects breast cancer across all stages, major types, and subtypes with a sensitivity of 81% (accurately identifies people with breast cancer) and a specificity of 93% (accurately identifies people with breast cancer). It has been verified that it can be detected by accurately excluding people who are not.

INOVIQ is a biotechnology focused on cancer testing and treatment. Earlier this week, the company reported on progress on its ovarian cancer test.

How is the test done?

CA15-3 is a substance in the blood that is associated with cancer. Other CA15-3 tests measure all types of CA15-3, whether from normal or cancerous cells. However, INOVIQ uses a specially designed protein called SubB2M that binds to the Neu5Gc sugar commonly found in cancer cells. By targeting this cancer-specific sugar, the test can focus on CA15-3, which is associated with cancer cells, improving the accuracy of cancer tests (breast, ovarian, prostate, pancreatic, etc.) I will.

The conventional CA15-3 test is used to monitor response to breast cancer treatment, but has insufficient sensitivity and specificity for screening.

The neuCA15-3 test was originally developed as an improved monitoring test.

Key findings from the research

This disease specificity study tested the ability of neuCA15-3 to discriminate between breast cancer and non-cancer diseases.

Compared to leading FDA-approved tests, the neuCA15-3 test achieved better sensitivity and specificity.

For comparison, other CA15-3 tests achieve approximately 60% sensitivity and 76% specificity in preoperative breast cancer (as opposed to 81% sensitivity and 93% specificity for neuCA15-3).

next step

INOVIQ plans to migrate the neuCA15-3 test to a high-throughput diagnostic platform, publish the results in a peer-reviewed journal, and secure a U.S. laboratory partner for commercialization.

“This study is an important milestone in the development of the neuCA15-3 breast cancer test,” said CEO Dr. Liane Hinch. “This test demonstrated excellent ability to detect breast cancer across all stages and major subtypes, while distinguishing breast cancer from non-breast cancer conditions.”

The global breast cancer diagnostics market was valued at USD 4.3 billion in 2022 and is expected to reach USD 7.7 billion by 2030.

Following the announcement, INOVIQ’s stock price rose 12% to 56 cents.