Reviewof Operations based on these in-house data comparing the performance of EXO-NET RUO to competitor exosome capture tools. Publication of these data is expected to generate additional research interest in EXO-NET and lead to further research collaborations, potential partnering opportunities and sales of EXO-NET. Multiple independent evaluations of EXO-NET were successfully completed by Australian and US research organisations that reported strong positive feedback. The data generated by these groups will be included in technical and marketing documentation to support future sales of the product. On 28 July 2021, INOVIQ announced that its collaborator, University of Queensland (UQ) had released promising data for its potential exosome-based ovarian cancer test. INOVIQ’s EXO-NET RUO product was used by the UQ researchers to isolate exosomes from the blood of ovarian cancer patients within 15 minutes, with high purity and yield. On 1 April 2022, INOVIQ announced it had expanded its collaboration with The University of Queensland (UQ) to develop a world-first exosome-based ovarian cancer screening test. The objective of these studies is to validate a multivariate index assay for the earlier detection of ovarian cancer. EXO-NET represents a scalable method for translating exosome-based assays into routine pathology and CLIA laboratory workflows. The studies will use EXO-NET to confirm the performance of the 7 exosomeassociated biomarkers currently used in the algorithmbased assay and aims to identify other informative exosome-associated miRNA and protein biomarkers that may improve the performance of the current algorithm. UQ will then use EXO-NET in the further development of the exosome-based ovarian cancer test, under a $2.7 million grant from the Australian governments Medical Research Future Fund (MRFF), that includes the clinical validation of the multiomic algorithm in a large independent cohort of samples. INOVIQ has an exclusive worldwide option to license UQ’s intellectual property for the development and commercialisation of the exosome-based ovarian cancer screening test. On 29 April 2022, INOVIQ advised that it is progressing plans to scale-up EXO-NET manufacture to meet expected demand for both its EXO-NET pan-exosome product and for custom-designed products to capture specific exosome subsets. INOVIQ is investing in manufacturing infrastructure to provide a 10-fold increase in production capacity to allow it to service both the research market and strategic diagnostic and therapeutic collaborations/ partnerships. INOVIQ is currently in the process of transferring the production of EXO-NET from its US research laboratory to its Australian facility for commercial manufacture under GoodManufacturing Process (GMP) conditions. GMP production of EXO-NET will provide strict quality control, agility to build customer-specific exosome isolation tools and provide entree into therapeutic markets. The EXO-NET research program is also focused on designing, building and testing new EXO-NET prototypes for capture and/or release of specific exosome subsets that may be relevant in targeted disease applications. On 27 July 2022, INOVIQ advised that it had progressed development of an EXO-NET exosome capture and release tool and provided it to a biotechnology company for evaluation. Initial evaluation of the product has provided positive data. This CR-NET prototype provides the basis for the development of high-capacity systems for the isolation of exosomes for therapeutic applications and, when optimized, will be produced at the newGMP facility in Melbourne. Research is ongoing with several collaborations being progressed with academic and industry groups with the aim of supplying pan or customised EXO-NET’s to partners for use in research and development of exosomebased diagnostics and therapeutics. BARD1 program The BARD1 technology is a biomarker platform that includes BARD1 DNA, RNA, protein, and autoantibodies that have potential application for earlier detection of breast, ovarian and lung cancers. Splice variants of BARD1 have been associated with cancer formation, progression, and poor prognosis. Splice variants of the BARD1 protein play a potential role in cancer formation, progression and prognosis. Previously, autoantibodies (AAbs) to these BARD1 splice variants have been identified across all stages of some cancers, including the early-stage diseases (Stages I and II) before symptoms are present. BARD1 AAbs potentially reflect the early immune response to tumour formation, which may enable BARD1 AAb tests to detect cancer earlier, before symptoms appear. Previously, the Company and its collaborator University of Geneva (UNIGE) performed exploratory, case-control studies showing initial high accuracy of BARD1 AAb tests for the detection of ovarian, breast and lung cancers compared to healthy controls on the Meso Scale Diagnostic platform. These research-stage BARD1 AAb tests were designed to measure autoantibodies to BARD1 variant proteins and their ability to determine the presence or absence of cancer using an algorithm. Subsequently, the Company contracted the development of a prototype RUO 20-plex BARD1 AAb kit on the Luminex platform that was evaluated by both UNIGE and Griffith University. The results showed that using two BARD1 peptides in combination with CA125 levels less than 70 16 INOVIQ Limited
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