Reviewof Operations Researchers concluded that “Neu5Gc serum biomarkers are a promising new tool for disease monitoring for breast cancer that may complement current imaging and biopsybased approaches.” The paper is available at https://www. inoviq.com/site/technology/publications. On 5 April 2022, INOVIQ announced it had partnered with US-based specialty contract diagnostics organisation, ResearchDx, under a Master Services Agreement to further the development and validation of its SubB2M immunoassay tests. ResearchDx offers a ‘start-tofinish’ partnership for the development of LDTs, in vitro diagnostics (IVDs) and companion diagnostics (CDx) including the design, development, validation and registration of diagnostics. Additionally, ResearchDx operates a high-complexity CAP9/CLIA10 certified laboratory, PacificDx. This makes ResearchDx is an ideal partner for INOVIQ’s SubB2M-based LDTs in the USA where the tests can be developed and validated for their intended use in the PacificDx clinical laboratory and offered to hospitals, clinicians and doctors’ offices to aid in the detection and monitoring of cancer. On 2 May 2022, INOVIQ announced it had partnered withMP Biomedicals Asia Pacific Pte Ltd under a Master Manufacturing Agreement for contract manufacture of the SubB2Mprotein to cGMP standard at its ISO 13485 certified Singapore facility. The agreement withMP Biomedicals enables a streamlined, scalable and costeffective production process for continuity of supply of the SubB2Mprotein for our commercial SubB2M tests. Post year-end, on 1 July 2022, INOVIQwas pleased to report that the performance of the SubB2M-CA15.3 assay for detection of breast cancer, initially developed by Griffith University, had been successfully replicated by ResearchDx. INOVIQ is now working with ResearchDx to advance the optimisation and validation of the SubB2M-CA15.3 assay, before advancing to clinical testing for breast cancer monitoring. The SubB2M-CA125 assay for ovarian cancer is also planned to undergo further development, optimisation and clinical testing for ovarian cancer monitoring. SubB2M immunohistochemistry (IHC) studies were also conducted to assess the utility of the cancer-associated biomarker Neu5Gc (using INOVIQ’s SubB2M cancer probe) to discriminate between benign skin lesions, malignant and metastatic melanoma. Post year-end on 26 July 2022, INOVIQ reported results from the melanoma 9 College of American Pathologists (CAP) accredited. CAP accreditation ensures laboratories meet industry standards fromCLIA, FDA and OSHA for test accuracy and patient diagnosis 10 Clinical Laboratory Improvement Amendments (CLIA) certified. CLIA regulates laboratory testing and requires clinical laboratories to be certified by the Center for Medicare andMedicaid Services (CMS) before they can accept human samples for diagnostic testing. 14 INOVIQ Limited
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