Summary

Fujirebio Diagnostics, Inc. has submitted its Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic test to the FDA, which could become the first commercially available blood-based test in the U.S. for assessing Alzheimer’s disease.

Takeaways

  1. First of its Kind: The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test aims to be the first blood-based diagnostic test for Alzheimer’s disease in the U.S.
  2. FDA Breakthrough Designation: The test received the FDA’s Breakthrough Device Designation, highlighting its potential to significantly improve Alzheimer’s diagnosis.
  3. Early Diagnosis Advantage: This test is designed to facilitate earlier and more accurate Alzheimer’s diagnoses, potentially leading to more effective interventions and the development of new therapies.

Fujirebio announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA). The new plasma test is expected to be the first commercially available blood-based IVD test in the U.S. to help in the assessment of Alzheimer’s disease (AD).

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, which received Breakthrough Device Designation from the FDA, is an IVD test using measurable pTau 217 and β-Amyloid 1-42 concentrations found in human plasma. The test combines these concentrations into a numerical ratio of pTau 217/β-Amyloid 1-42 to identify patients with amyloid pathology associated with AD. β-Amyloid neuritic plaque pathology in the brain is believed to contribute to the loss of cognitive function that characterizes AD.


Diagnosing a Devastating Condition

AD is a devastating condition that afflicts more than 6 million Americans and is a leading cause of disability and death. Access to reliable diagnostic tools is currently limited. Diagnosis involves a variety of subjective measures and costly or invasive procedures, such as amyloid positron emission tomography (PET) scans and cerebral spinal fluid (CSF) tests. As a result, many patients are not diagnosed until their disease has advanced, limiting the benefits of available treatment options.

Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio Test Builds on Existing Technology

The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses Fujirebio’s fully automated Lumipulse G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022.

“The lack of effective and accessible diagnostics for AD contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, president and CEO at Fujirebio Diagnostics, Inc. “We designed our Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test to help physicians and patients with signs and symptoms of cognitive decline obtain an AD diagnosis much earlier when interventions are more effective. An early and accurate diagnosis will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of AD increases with a rapidly aging population globally. As part of our worldwide commitment to improving the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”