The hTERT test is registered as an IVD medical device in the United States (Class I IVD), Europe (CE-IVD marking), Australia (Class I IVD) and South Korea (Class II IVD) for use as a clinical diagnostic by pathology laboratories for the detection of hTERT in cytopathology samples. It is used by pathologists as an adjunct to urine cytology to help resolve indeterminate cytology results and identify patients with increased risk of bladder cancer10. On 23 November 2022, INOVIQ announced that it would revert to a direct distribution model for its hTERT test in the US from January 2023, selling hTERT directly to laboratory customers. There was a smooth transition of customers, with INOVIQ expected to benefit from improved product revenues and gross margins. The agreement between INOVIQ and US-based contract sales organisation, Percorso Life Sciences, was extended to provide warehousing and logistics services to deliver hTERT direct to INOVIQ’s US customers. Revenues from hTERT sales grew during the year, with the Group’s hTERT test achieving revenues of $363,209 (2022: $276,745). This growth was attributed to maintaining the current customer base and benefiting from the direct customer sales model, with further upside anticipated in FY24. RESEARCH & DEVELOPMENT PROGRESS Our technologies have the potential to deliver significant commercial and clinical benefits to patients, the healthcare system and our shareholders. R&D activities during FY23 focused on validation of our SubB2M tests, expanding the EXO-NET data package, developing new EXO-NET products (TEXO-NET, NEURO-NET, HT EXO-NET) and progressing its exosome-based ovarian cancer test with the University of Queensland. SUBB2M PROGRAM SubB2M is an engineered protein that specifically detects the pan-cancer biomarker Neu5Gc that is found in multiple human cancers. INOVIQ is developing SubB2M immunoassays for improved monitoring of breast and ovarian cancers, and is evaluating a SubB2M SPR test for detection of Neu5Gc in a general health panel. The SubB2M program focused on completing analytical and clinical validation of our SubB2M/CA15-3 test for breast cancer, planning for its SubB2M/CA125 for ovarian cancer, and evaluation of a potential SubB2M-SPR multicancer test on the Nicoya platform. 10 Allison et al. Evaluation of Sienna Cancer Diagnostics hTERT Antibody on 500 Consecutive Urinary Tract Specimens. Acta Cytologica 2018. DOI: 10.1159/000489181 13 Annual Report 2023
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