Melbourne, Australia and Irvine, CA USA, 5 September 2023 (AEST): INOVIQ Limited (ASX:IIQ) (INOVIQ), a developer of next-generation exosome solutions and precision diagnostics, and ResearchDx Inc (ResearchDx), a Contract Diagnostics Organization (CDO) offering complete in vitro diagnostic (IVD) services, today announced a license and supply agreement for INOVIQ’s EXO-NET® exosome capture technology to enable provision of exosome isolation, biomarker discovery and diagnostics development services in the USA.
The ResearchDx partnership builds on the previously announced Joint Marketing Agreement for INOVIQ’s EXO-NET exosome capture technology and Promega Nucleic Acid purification systems (ASX: 6 July2023).
EXO-NET license agreement to ResearchDx
INOVIQ and ResearchDx have signed a license and supply agreement that will enable the companies todeliver EXO-NET enabled High-Throughput (HT) exosome isolation, biomarker discovery and diagnostics development services to customers in the USA. Establishment of EXO-NET services in the USA follows the recent introduction of INOVIQ’s EXO-NET services from its Australian laboratory (see below).
This new agreement combines the expertise of ResearchDx in the development and validation of IVD diagnostics, with INOVIQ’s disruptive EXO-NET technology, exosome capture tools and exosome- based diagnostics expertise.
Under the agreement, US customers will be offered a wide range of contract research services from ResearchDx using INOVIQ’s EXO-NET exosome capture tools to suit their exosome isolation, biomarker discovery and diagnostics development needs.
INOVIQ and ResearchDx are excited to leverage their combined exosome and IVD diagnostics development expertise to advance exosome-based diagnostics development for companion diagnostics to deliver the right medicines to the right patients to improve therapeutic outcomes.
Dr Leearne Hinch, INOVIQ CEO, said: “ResearchDx is a key part of our strategy to expand INOVIQ's EXO-NET exosome services in the USA. It builds on our established and successful contract research relationship with them for development of our SubB2M tests. By partnering with ResearchDx, US customers nowhave access to a full range of EV isolation, biomarker discovery and diagnostic development services by aCAP and CLIA accredited Contract Research Organisation. This is an important, strategic move that enables us to provide high quality EXO-NET services to customers in the US, Australia and elsewhere, expanding our revenue generation opportunities for EXO-NET.”
ResearchDx EXO-NET services
ResearchDx is a US-based full-service contract diagnostics organisation (CDO) that offers a ‘start- finish’ partnership for the development of companion diagnostics (CDx), in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). ResearchDx has built a strong reputation with biopharma and diagnostics companies in the US and internationally for its integrated diagnostics business model, capabilities and expertise in the design, development, validation, and registration of diagnostics.
Dr Mat Moore, ResearchDx Principal & Co-Founder, said: “We look forward to offering EXO-NET enabled EV isolation, biomarker discovery and diagnostic development services in our Development, GLP, and CLIA accredited laboratories to US customers. EXO-NET is a powerful exosome isolation platform that has the potential to enable earlier disease detection, and the more accurate monitoring of disease progression and response to therapy.”
ResearchDx previously evaluated INOVIQ’s EXO-NET technology for both manual and automated extracellular vesicle (EV) isolation and have now validated EXO-NET isolation in its laboratories for high-throughput (HT) exosome isolation. ResearchDx will now offer a broad range of exosome services using EXO-NET to academic, biotech and pharmaceutical customers in the USA. EXO-NET services will include EV isolation, biomarker discovery (DNA, RNA, proteins and lipids)and diagnostics development in its accredited laboratories.
• INOVIQ and ResearchDx sign a license and supply agreement for INOVIQ’s EXO-NET® pan- exosome capture product to provide EXO-NET services in the USA
• ResearchDx Inc is a US-based specialty contract diagnostics organisation, providing a full-suite of concept-to-market diagnostic biomarker discovery, assay development, clinical validation and IVD registration services, including for companion diagnostics
• Agreement enables ResearchDx to provide EXO-NET enabled high-throughput exosome isolation, biomarker discovery and diagnostics development services to US customers
ABOUT INOVIQ LTD
INOVIQ Ltd (ASX:IIQ) (INOVIQ) is developing and commercialising next-generation exosome solutions and precision diagnostics to improve the diagnosis and treatment of cancer and other diseases. The companyhas commercialised the EXO-NET pan-exosome capture tool for research purposes and the hTERT test as an adjunct to urine cytology testing for bladder cancer. Our cancer diagnostic pipeline includes blood tests in development for earlier detection and monitoring of ovarian, breast and other cancers. For moreinformation on INOVIQ, visit www.inoviq.com.
ABOUT RESEARCHDX INC
ResearchDx is a US-based, integrated start-to-finish partner offering custom diagnostic development services from biomarker discovery, assay optimization, clinical validation, clinical trial management and regulatory approval to final kit manufacture. ResearchDx is CLIA licensed, CAP accredited, ISO 13485certified and GxP compliant, supporting diagnostic development partnerships worldwide.
BACKGROUND TO INOVIQ EXO-NET EXOSOME RESEARCH TOOLS AND SERVICES
INOVIQ’s EXO-NET pan-exosome capture is a research use only 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.
INOVIQ recently collaborated with Promega Corporation (Promega) to develop a High-Throughput (HT) EXO-NET isolation system that can process up to 200,000 samples per year in a clinical laboratory. Subsequently, INOVIQ and Promega announced a global joint marketing agreement to co-market INOVIQ’s EXO-NET exosome capture technology and Promega Nucleic Acid purification systems (ASX: 6 July 2023). Thispartnership is expected to accelerate adoption of EXO-NET by providing customers with a complete solution formanual and high-throughput exosome isolation and nucleic acid extraction to enable their exosome research.
INOVIQ has established its own EXO-NET services capability to offer HT exosome isolation, biomarker discovery and diagnostics development services to Academic and Industry customers from its Australianlaboratory (ASX: 28 July 2023). This is expected to provide potential EXO-NET service revenue to the Company and potentially lead to future partnering agreements for exosome diagnostics.
ABOUT EXOSOMES AND THE GLOBAL EXOSOMES MARKET
Exosomes are small extracellular vesicles (EVs, or exosomes) released by cells. They are nanometre- sized lipid membrane packages that encapsulate (and protect from degradation) DNA, RNAs and proteins. Exosomes and the messages they carry form part of the cell-to-cell communication system and play an important role in health and disease. Intercepting and reading exosomal messages has important applications in the research, diagnosis and treatment of many diseases, including cancer, neurological, cardiovascular, inflammatory and other diseases and disorders.
Clinical interest in exosomes has grown exponentially due to their commercial potential in biomarker discovery, earlier disease detection, companion diagnostics, targeted therapies, drug delivery and regenerativemedicine. However, the exosome promise has been limited by slow, impure and inefficient traditional methods to isolate exosomes. This has created a need for improved exosome isolation methods that deliver speed, purityand yield for research and commercial applications.
INOVIQ has developed and commercialised EXO-NET to enable fast, efficient and scalableexosome isolation from biofluids to intercept and decode the messages that they contain. This information can be used for assessing patient well-being or disease risk,diagnosis of disease, selecting the best treatment option, or monitoring a patient’sresponse to treatment.
The global exosome research market was valued at US$144 million in 2021 and isexpected to reach US$661 million by 2026, growing at a CAGR of 35.6%1 North America was the largest geographic segment representing 41.5% of the market followed by Europe at 20%. The Kits and Reagents product segment in which INOVIQ’s EXO-NETresearch tools fit, was valued at US$71 million in 2021 and is forecast to reach US$311million by 2026.
The global exosomes market was valued at US$1.8 billion in 2022 and is forecast to reach US$8.7 billion by 2029, growing at 25% CAGR.2 Market growth is driven by increased investment in exosome research, the rising prevalence of chronic diseases, increased demand for non-invasive diagnostics and targeted therapies, and technological advancements in exosome isolation and purification. North America was the largest geographic segment in 2022. Clinics (hospitals and clinics) were the largest end-users, followed by Pharmaceutical (biomarker discovery and drug development) and Academic (academic and researchinstitutes) segments.
FORWARD LOOKING STATEMENTS
This announcement contains certain ‘forward-looking statements’ within the meaning of the securities laws of applicable jurisdictions. Forward-looking statements can generally be identified by the use of forward-looking words such as ‘may’, ‘should’, ‘expect’, ‘anticipate’, ‘estimate’, ‘scheduled’ or ‘continue’ or thenegative version of them or comparable terminology. Any forecasts or other forward-looking statementscontained in this announcement are subject to known and unknown risks and uncertainties and may involve significant elements of subjective judgment and assumptions as to future events which may or may not be correct. There are usually differences between forecast and actual results because events and actual circumstances frequently do not occur as forecast and these differences may be material. The Company doesnot give any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this announcement will actually occur and you are cautioned not toplace undue reliance on forward-looking statements.
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