INOVIQ Limited (ASX: IIQ) is pleased to announce game-changing results from its EXO-OC™ ovarian cancer test presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on 1 June 2025 in Chicago. The Poster titled Early detection of ovarian cancer: An accurate high-throughput extracellular vesicle test is copied below.
The test uses proprietary technology to isolate exosomes and combines multiple exosomal biomarkers in an AI-enhanced algorithm to enable the early and accurate detection of ovarian cancer. Since reporting high level results from a biomarker study validating protein biomarkers on 3 December 2024, INOVIQ worked with one of Australia’s most highly rated computational scientists, Prof Amanda Barnard, to independently analyse its miRNA biomarker data and develop AI machine-learning algorithms to enhance the detection of early-stage ovarian cancer (Stage I and II).
The test is run on a fully-automated, high-throughput instrument suitable for clinical pathology laboratories, with capacity to process over 500 samples daily.
In a 532-sample, retrospective, blinded, case-control study, the test demonstrated 77% sensitivity at 99.6% specificity for detection of ovarian cancer across all stages, meeting the clinically accepted performance criteria for effective population screening. Importantly, the test accurately detected all Stage I and II ovarian cancers, with no missed early-stage diagnoses.
An Australian Provisional Patent Application (APPA) was filed on 29 May 2025 to secure intellectual property rights covering various protein and RNA biomarker combinations and methods for the exosome ovarian cancer test.
Ovarian cancer is usually asymptomatic in the early stages of disease. It is often diagnosed at a late-stage after symptoms have appeared resulting in a 5-year survival rate of only 49%. Early detection of ovarian cancer may increase 5-year survival from 30% to 93%.[1] Early detection may improve treatment options, health outcomes and survival rates for women diagnosed with ovarian cancer.
The next steps in the development and commercialisation of the test are:
- Validation studies: to confirm the test’s specificity for ovarian cancer versus other cancer types and inflammatory conditions, and to evaluate its performance in high-risk populations.
- Clinical and regulatory: to seek Breakthrough Device Designation and pursue FDA approval via the Premarket Approval pathway. A clinical study will be conducted to assess the test’s effectiveness for screening asymptomatic, average-risk women.
- Commercialisation: launch the test as a Laboratory Developed Test with a US laboratory partner, enabling early access to the screening test for early ovarian cancer detection. Following regulatory approval, EXO-OC will be marketed as an In Vitro Diagnostic to support broader clinical adoption.
Prof Carlos Salomon, Director of UQ Centre for Extracellular Vesicle Nanomedicine and Member of INOVIQ Medical and Scientific Advisory Board, said: “This study demonstrates that the EXO-OC ovarian cancer screening test can accurately identify the disease across all stages, with outstanding sensitivity and specificity that meet internationally recognised criteria. Transferring the test to a CLIA-certified laboratory in the United States will help accelerate the translation of this innovation into clinical practice, where it has the potential to save women’s lives by enabling earlier diagnosis and intervention. This achievement is a significant step forward in the fight against the world’s most lethal gynaecological cancer.”
Dr Leearne Hinch, CEO, added: “Our EXO-OC test addresses a critical unmet need for early detection of ovarian cancer. INOVIQ is now positioned as a global leader in exosome technology, offering best-in-class exosome isolation and diagnostic solutions that can transform precision oncology. We are focused on the rapid commercialisation of our test, first as a Laboratory Developed Test and then as a regulatory approved In Vitro Diagnostic for ovarian cancer screening.”
Chairman, David Williams, said: “Ovarian cancer is the eighth most common cancer in women. Globally, there were over 314,000 new cases and 207,000 deaths in 2020. There are no recommended screening tests for ovarian cancer in average-risk, asymptomatic women so it is very exciting if our test can offer a non-invasive, accurate and reliable diagnostic test for this significant unmet need.”
Authorised by the Company Secretary, Mark Edwards.
About us:
INOVIQ Ltd (ASX: IIQ) is a leader in exosome technology pioneering the development of next-generation diagnostics and therapeutics to improve patient outcomes in cancer. Our product portfolio includes commercial-stage exosome isolation products, clinical-stage diagnostics for ovarian cancer screening and breast cancer monitoring, and a preclinical-stage CAR-exosome therapy for triple negative breast cancer. For more information on INOVIQ, visit www.inoviq.com.
Contact details:
Dr Leearne Hinch, Chief Executive Officer: E [email protected], M +61 400 414 416
Lisa Maguire, Freelance Communications Consultant (Assisting INOVIQ Limited): M 0499 920 762
