IXICO plc outlined its role in the validation of a new Alzheimer's Disease (AD) diagnostic biomarker for client Fujirebio Diagnostics Inc. ("Fujirebio"), a global leader in the field of high-quality in vitro diagnostic (IVD) testing. The imaging analysis, conducted via IXICO's AI-driven platform, has supported Fujirebio's 510(k) FDA clearance for a new blood-based test that will help advance diagnosis and drug development in AD. The analysis included datasets from the Global Alzheimer's Platform Foundation's Bio-Hermes-001 study, of which both Fujirebio and IXICO are partners.
As Bio-Hermes' imaging partner, IXICO led the standardisation, collection and expert analysis of PET data which served as the gold standard assessment of amyloid pathology in Fujirebio's FDA filing. On 16 May Fujirebio announced that it received clearance for its Lumipulse®? G pTau 217/b-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology In adult patients, aged 50 or older, being evaluated for Alzheimer's disease and other causes of cognitive decline.
The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid the identification of patients with amyloid pathology associated with AD. Fujirebio's FDA clearance is based on data from a multi-center clinical study of 499 individuals in which amyloid positivity derived from the Lumipulse G pTau217/ss-Amyloid 1- 42 Plasma Ratio has been shown to be sufficiently comparable with results obtained through amyloid PET scan or CSF tests. These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer's disease at the time of the test in patients who are cognitively impaired.
The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information. The analysis by IXICO corresponds to the announcement made by the Company on 27 February 2025 that it had won a contract with an, at the time, undisclosed multinational biotechnology company.
IXICO is now able to confirm that this company was Fujirebio. The imaging element of the clinical trial conducted on behalf of Fujirebio marks an expansion in IXICO's neuroimaging biomarker analyses capabilities beyond therapeutic clinical trial assessment to the analysis and validation of clinical diagnostic biomarkers.
