INOVIQ Limited announce that the Ovarian Cancer 97 study (OC97) has been completed by the Centre for Clinical Research, The University of Queensland (UQ), confirming the utility of EXO-NET for EV biomarker discovery and generation of a multivariate index assay (MIA) with over 90% accuracy for the detection of early-stage ovarian cancer. In April 2022, it was announced that INOVIQ and UQ commenced an evaluation of EXO-NET that upon success would enable UQ to use EXO-NET in the further development of its ovarian cancer screening test (ASX: 1 April 2022). The objective of the OC97 study was to establish that EXO-NET is fit-for- purpose in ovarian cancer EV) biomarker (microRNA and protein) discovery and development of an EV-based ovarian cancer diagnostic.

INOVIQ worked with UQ's commercialisation company UniQuest to negotiate the Umbrella Research and Option Agreement (Agreement) announced in April 2022. Under this Agreement, INOVIQ holds the exclusive option to license UQ's intellectual property in the EV-based ovarian cancer test, worldwide. EXO-NET was used to isolate EVs from plasma obtained from women with early-stage ovarian cancer, benign ovarian masses and normal healthy women.

EV proteins (n=1522) and microRNAs (n=1435) were identified by quantitative mass spectrometry and small RNA sequencing, respectively. Of the EV biomarkers identified, 27 were highly informative (p<0.0001) of early-stage (stage I and II) ovarian cancer. When selected biomarkers were combined in a multivariate algorithm, a high-performing, cross- validated classification model was generated with AUC >0.98, sensitivity >0.92 and specificity >0.92.

Furthermore, the algorithm correctly identified 92% of cases (cancers) and controls (healthy) in an independent test set. EXO-NET isolates a subpopulation of extracellular vesicles from biofluids (including plasma) for the downstream analysis and identification of informative biomarkers of disease (e.g. proteins, mRNA and miRNA). The OC97 study validated the use of EXO-NET for use in biomarker discovery and EV diagnostic applications.

The next step in the development of the EV Ovarian Cancer Screening Test is an analytical validation study (OC250) to confirm the performance of EXO-NET and the EV biomarkers in serum samples and plasma. If substantial equivalence between serum and plasma is established, it will facilitate access to the world's ovarian cancer serum biobank. This will be critically important for future clinical studies.

The OC250 study is expected to commence in January 2023 with results expected in June 2023. This UQ EV Ovarian Cancer project has previously received grant funding support from the Ovarian Cancer Research Foundation and is currently funded by the Australian Government's Medical Research Future Fund (MRFF), under which INOVIQ plans to contribute its EXO-NET exosome isolation product, in-kind expertise and pay patent costs.