Precision diagnostics company INOVIQ (ASX: IIQ) has achieved noteworthy results from an independent clinical validation study of its SubB2M/CA15-3 test for breast cancer detection. The study has reported high accuracy (87%), sensitivity (81%), and specificity (93%) for the test, outperforming a leading approved CA15-3 test.
INOVIQ CEO, Dr Leearne Hinch, said, “The outstanding results from this independent clinical validation study of our SubB2M breast cancer test represent a major milestone for INOVIQ. Our SubB2M/CA15-3 blood test detected all-stages of breast cancer with 81% sensitivity and 93% specificity, outperforming a leading CA15-3 test.”
INOVIQ’s SubB2M technology uses a special protein to detect a biomarker called Neu5Gc. This biomarker is found in many types of cancers in humans. The SubB2M test is designed to make existing cancer tests more accurate and useful in detecting and monitoring cancer. Some examples of these existing tests are CA15-3 for breast cancer, CA125 for ovarian cancer, PSA for prostate cancer, and CA19.9 for pancreatic cancer.
Currently, CA15-3 tests are commonly used to monitor the response to breast cancer treatment and check for the return of the disease. However, these tests are not very sensitive or specific enough for detecting early-stage cancer. They are usually used together with other diagnostic tests. INOVIQ is developing the SubB2M/CA15-3 test as an all-inclusive solution to improve monitoring of breast cancer.
INOVIQ partnered with a contract research organisation ResearchDx in the US to develop and validate the SubB2M tests. The study aimed to evaluate the clinical performance of the SubB2M/CA15-3 test across all stages of breast cancer compared to healthy controls. Its second goal was to compare the performance of the SubB2M/CA15-3 test to a leading approved CA15-3 test in the same samples.
Positive results have already been reported from the initial validation of the SubB2M/CA15-3 test, showing that it has 78% sensitivity and 80% specificity in detecting breast cancer. The Company also found that its test significantly reduces misdiagnoses with lower false positive results (7%) and false negative (19%) rates.
Principal of ResearchDx, Dr Mathew Moore, added, “These outstanding data clearly improve on existing CA15-3 tumour marker tests routinely used for monitoring breast cancer. The SubB2M/CA15- 3 test detects all stages of breast cancer with high accuracy, which could be a game-changer for clinicians and clinical practice for screening of undiagnosed breast cancer and in monitoring diagnosed breast cancer.”
From a marketing perspective, INOVIQ CSO, Dr Gregory Rice, shared, “Having completed rigorous analytical and clinical validation, the next step involves conducting disease monitoring studies and assessing the test’s impact on clinical decision-making in collaboration with KOLs and potential partners in the United States.”
The next step for INOVIQ is to present this data and the Company’s development plans to potential partners and KOLs (key opinion leaders) to advance commercial discussions for its SubB2M/CA15-3, SubB2M/CA125 and SubB2M multi-cancer tests. It also plans to conduct a monitoring study to compare the performance of the SubB2M/CA15-3 test with the approved CA15-3 tests in terms of treatment response and detecting the recurrence of the disease.
INOVIQ is collaborating with ResearchDx and its clinical advisors to finalise the plan for this clinical validation. The study is anticipated to be finished by the end of Q2 FY24, and once completed, the test is expected to be ready for the market.
Alinda is a Business Reporter for The Sentiment
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