FDA Clearance of Alzheimer's Diagnostic Biomarker

IXICO

10/06/2025 07:00

RNS Number : 0852M

IXICO plc

10 June 2025

 

IXICO plc

("IXICO", the "Company" or the "Group")

 

IXICO assists first FDA clearance of new Alzheimer's Disease

blood based diagnostic biomarker

 

 

10 June 2025 IXICO plc (AIM: IXI) - London, UK. IXICO, a global leader in neuroscience imaging and biomarker analytics, using its AI-driven platform to help advance drug development in neurological disorders, today 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 groundbreaking 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/β-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.

 

Monte Wiltse, President and CEO of Fujirebio Diagnostics, Inc. commented: "The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment. The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective."

 

Bram Goorden, Chief Executive Officer of IXICO, commented: "This is a major milestone in AD biomarker development and will provide a significant boost to biomarker use in clinical diagnosis and clinical trials. 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.

 

As we witness the first neurological disease modifying treatments coming to the market, IXICO  will continue to build upon its 20-year track record and proudly contribute to CNS biomarker innovation delivering cutting-edge science and technology for partners and patients."

 

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For further information please contact:

 

IXICO plc
+44 (0) 20 3763 7499
Grant Nash, Chief Financial Officer
James Chandler, Chief Business Officer
Cavendish Capital Markets Limited
(Nominated Adviser and Sole Broker)
+44 (0) 20 7220 0500
Giles Balleny (Corporate Finance)
Nigel Birks (Healthcare Specialist Sales)
Harriet Ward (Corporate Broking)
Michael F Johnson (Sales)


 

 

About Fujirebio Diagnostics, Inc. 

Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at www.fujirebio.com.

 

 

About IXICO www.IXICO.com

IXICO is a global leader in neuroscience imaging and biomarker analytics, using its proprietary AI-driven platform to help advance the treatment of neurological disorders and reduce the uncertainties associated with drug discovery, development and monitoring.   As a key part of the global neurological disease research community, the Company has built a global reputation and 20-year track record as an end-to-end Imaging Contract Research Organisation (iCRO) working with leading pharma companies, innovative biotechs, disease consortia and non-profit organisations. The IXICO has supported hundreds of neurological clinical trials, analysed hundreds of thousands scans and built an expansive network of expert imaging centres around the world.  

 

The IXICO Platform is tailor-made for neurological disease, reliably processing data from global trials, precisely measuring key imaging biomarkers associated with the identification, progression and treatment of diseases such as Alzheimer's, Huntington's and Parkinson's.  Image data is interrogated by the Platform and IXICO's expert scientists translating complex data into clinically meaningful while minimizing data variability and increasing reproducibility.

 

 

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