10th Jun 2025 14:25
(Alliance News) - Ixico PLC on Tuesday hailed regulatory approval for a new Alzheimer's test, which it was contracted to analyse during clinical trials.
The London-based medical research firm uses neuroscience imaging and biomarkers to analyse trial data.
Ixico said it was contracted by Fujirebio Diagnostics Inc, a Tokyo-based biomarker research company, to assist with the development of a new blood-based test for Alzheimer's disease called Lumipulse.
Though the partnership was confirmed back in February, Ixico was unable to name its contractor until Tuesday.
The British firm said its AI platform played a role in Fujirebio securing approval from the US Food and Drug Administration.
Evidence of Lumipulse's efficacy included data from the Global Alzheimer's Platform Foundation's Bio-Hermes-001 study, of which both Ixico and Fujirebio are partners.
Ixico was responsible for data collection, standardisation, imaging and analysis. The data was then used as the "gold standard assessment for amyloid pathology" when Fujirebio assessed the Lumipulse diagnostic test.
Lumipulse was shown to be a reliable indicator of amyloid pathology, which occurs in patients with Alzheimer's and cognitive decline.
Fujirebio received clearance for Lumipulse back in May. The test was designated a "breakthrough device" by the FDA. It is the first blood-based in-vitro test for Alzheimer's to be cleared by the US regulator.
Monte Wilte, president and chief executive of Fujirebio noted: "The lack of effective, accessible and minimally invasive diagnostics for Alzheimer's disease contributes to its late diagnosis and inadequate treatment."
Lumipulse, Wilte continued, will help patients and doctors diagnose the illness earlier, and intervene when intervention is still effective.
Ixico's Chief Executive Bram Goorden added: "This is a major milestone in Alzheimer's disease biomarker development and will provide a significant boost to biomarker use in clinical diagnosis and clinical trials."
Ixico shares were 5.7% higher at 12.15 pence each on Tuesday afternoon in London.
By Holly Munks, Alliance News reporter
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