Posted: 27 February 2024
INOVIQ Limited (ASX:IIQ or INOVIQ) is excited to announce the successful completion of its breast cancer study.
In a 2023 clinical validation study (n=483), INOVIQ’s SubB2M/CA15-3 test detected over 80% of breast cancers across all stages with 93% specificity. The recently completed monitoring study showed INOVIQ’s test detected breast cancer across key cancer subtypes, correctly identified 19% more breast cancers than a leading approved test and was effective for monitoring breast cancer. The Company intends to use these results to attract a partner to speed up the commercialisation of the test.
Breast Cancer study
The aim of the study was to demonstrate the performance of INOVIQ’s test for detection of breast cancer subtypes and post-treatment monitoring compared with an FDA cleared test (Roche Elecys). Serum samples (n=277) were provided by The University of Queensland and analysed by US CRO ResearchDx.
The cancer subtype leg of the study used 159 pre-treatment serum samples from women diagnosed with breast cancer. The test detected breast cancer across all key subtypes (HR+, HER2+ and TNBC)1. Importantly, the test outperformed the FDA approved test by correctly identifying 19% more histologically-confirmed breast cancers.
In the monitoring leg of the study, CA15-3 concentrations were assessed in serum obtained from 12 women before treatment and then at up to 5 subsequent time points post-treatment. The study established equivalence between INOVIQ’s test and the comparator test for monitoring breast cancer.
Next steps
INOVIQ now intends to present its SubB2M/CA15-3 test data package to potential partners and key opinion leaders to secure a partner in the US to speed the commercialisation of the test and revenue generation.
INOVIQ will also sponsor a larger in-clinic trial to gain further data to substantiate the performance of its test for monitoring breast cancer treatment responses and to facilitate clinical adoption. INOVIQ is in discussions with CROs to undertake a larger study.
CEO Dr Leearne Hinch said: “The SubB2M/CA15-3 test is designed to be an aid for monitoring breast cancer. The results of this study are powerful having d
Chairman David Willams said: “These are exciting results because this simple, accurate and affordable test could provide a more effective test for detecting and monitoring breast cancers, and lead to better patient management. The ability to identify cancer subtypes could be a game changer. In the meantime, we will use these results to quickly pursue alliances and partnerships to bring our technology to market.”
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