REG - IXICO plc - FDA Clearance of Alzheimer's Diagnostic Biomarker

IXICOAnnouncement

10/06/2025 07:00

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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."

 

Ends

 

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           +44 (0) 20 7220 0500

 (Nominated Adviser and Sole Broker)
 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 (https://www.fujirebio.com/) .

 

 

About IXICO www.IXICO.com (http://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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