PRODUCT PORTFOLIO INOVIQ’s product portfolio currently includes an in-market exosome research tool and adjunctive diagnostic test for bladder cancer detection, and a deep pipeline of SubB2M and exosome diagnostic tests in development for the earlier detection and monitoring of breast and ovarian cancers. 7 Food and Drug Administration (FDA) 8 PreMarket Notification (510k) 9 PreMarket Approval (PMA) COMMERCIAL PROGRESS EXO-NET® pan-exosome capture EXO-NET pan-exosome capture is a research use only (RUO) tool for the isolation of exosomes from plasma, serum, urine, saliva and cell-conditioned media. EXO-NET delivers fast, efficient and scalable exosome isolation compared to traditional exosome isolation methods. It is suitable for exosome-based biomarker discovery and diagnostics development. EXO-NET is initially being commercialised as an exosome isolation tool for use in the rapidly growing exosome research market with the goal of embedding the technology into research applications that may underpin future licensing of EXO-NET for use in the development and commercialisation of exosome-based diagnostics for cancer, neuro-degenerative, cardiac, inflammatory and other applications. The product is manufactured by INOVIQ in 1mL, 0.5mL and 0.25mL pack sizes containing EXO-NET coated magnetic beads for processing up to 60, 30 or 15 samples. The commercialisation strategy for INOVIQ’s diagnostics is to first launch its tests as laboratory developed tests (LDTs) in the USA, followed by FDA7 In Vitro Diagnostic (IVD) submissions and clinical studies to support 510k clearance8, de novo or PMA9 registrations, depending on the indication for use. Product Indication Use Research Assay Development Clinical Development Market Market hTERT* Bladder Cancer Adjunct to cytology SubB2M-BC Breast Cancer Monitoring SubB2M-OC Ovarian Cancer Monitoring SubB2M-SPR Multi Cancer Prescreening EXO-OC** Ovarian Cancer Screening EXO-NET RUO pan-EV capture Research tool TEXO-NET RUO tumour derivedEV capture Research tool NEURO-NET RUO brain derived-EV captured Research tool EXO tools/Dx SubB2M Dx IVD-Class 1 USA LDT RUO RUO RUO LDT LDT LDT * Adjunct to urine cytology to assist the detection of bladder cancer ** Umbrella Research and Option Agreement with the University of Queensland 11 Annual Report 2023
RkJQdWJsaXNoZXIy MjE2NDg3