IXICO PLC (LSE:IXI, OTC:PHYOF), the neuro-imaging specialist, played a key role in the US approval of a new blood test designed to help doctors identify signs of Alzheimer’s disease in patients showing memory problems.
The company provided imaging analysis for Fujirebio Diagnostics, a Japanese-owned diagnostics group, which in May secured regulatory clearance from the US Food and Drug Administration (FDA) for its new Lumipulse test.
The assay measures proteins in the blood that are linked to amyloid build-up in the brain, one of the hallmarks of Alzheimer’s.
The test is the first of its kind in the US to receive the FDA green light for diagnosing the disease through a simple blood sample, offering a less invasive and potentially more scalable alternative to brain scans or spinal fluid tests.
IXICO used its artificial intelligence tools to analyse data from the Bio-Hermes-001 study, an international clinical trial backed by the Global Alzheimer’s Platform Foundation.
In that study, brain scans were used as the benchmark for confirming the presence of amyloid pathology — a method IXICO helped standardise and interpret.
The blood test, named the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, is aimed at adults aged 50 or over who are experiencing cognitive symptoms. It is designed for use in specialist care settings, and results should be interpreted alongside other clinical assessments.
Fujirebio’s FDA submission was based on data from nearly 500 patients and showed that the test produced results broadly in line with those from more established methods, such as amyloid PET imaging or lumbar punctures.
The company had earlier received Breakthrough Device Designation from the FDA, a status intended to speed up the review process for innovative medical technologies.
"This is a major milestone in AD biomarker development and will provide a significant boost to biomarker use in clinical diagnosis and clinical trials," said CEO Bram Goorden.
"As a first-line screening tool, the blood-based biomarker allows to efficiently funnel those subjects to a gold-standard PET assessment that require confirmation of amyloid positivity or that resulted in an indeterminate blood-based biomarker assessment.
"Multimodal use of complementary biomarkers can increase screening throughput, a key requirement when targeting pre-symptomatic populations."