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IXI

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VERY GOOD

IXICO Assists in FDA Clearance of New Alzheimer's Diagnostic Biomarker

Why we think this is very good

The RNS announcement about IXICO's role in the FDA clearance of a new Alzheimer's diagnostic biomarker is a significant positive development for the company. It represents a major milestone in the advancement of Alzheimer's disease diagnostics and drug development, which is directly aligned with IXICO's core business. This news is transformational for the company and is likely to have a significant positive impact on its future prospects.

Key Points

  • IXICO assisted Fujirebio Diagnostics in obtaining FDA clearance for a new blood-based Alzheimer's Disease diagnostic test
  • The test 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
  • IXICO's imaging analysis, using its AI-driven platform and data from the Bio-Hermes-001 study, supported the validation of the new test
  • This represents a major milestone in the advancement of Alzheimer's disease diagnostics and drug development

Summary

The healthcare technology company has assisted in the FDA clearance of a new blood-based test that will help advance diagnosis and drug development in Alzheimer's disease.

IXICO, a global leader in neuroscience imaging and biomarker analytics, has played a key role in supporting Fujirebio Diagnostics, Inc.'s successful 510(k) FDA clearance for a new blood-based Alzheimer's Disease (AD) diagnostic test. The analysis conducted by IXICO's AI-driven platform, using datasets from the Bio-Hermes-001 study, has helped validate the new test which 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.

Key Dates

16 May 2025
Fujirebio announced FDA clearance for its Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test
GENERAL UPDATE