In a groundbreaking move set to revolutionize Alzheimer’s diagnostics, Fujirebio has officially submitted its Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test to the U.S. Food and Drug Administration (FDA). This innovative in-vitro diagnostic (IVD) test is poised to be the first commercially available blood-based diagnostic tool in the United States for Alzheimer’s disease (AD) assessments.

A New Era in Alzheimer’s Diagnosis

This state-of-the-art blood test, which has received the FDA’s Breakthrough Device Designation, leverages measurable concentrations of pTau 217 and β-Amyloid 1-42 found in human plasma. By combining these values into a numerical ratio, the test identifies patients exhibiting amyloid pathology—a key characteristic associated with Alzheimer’s. The presence of β-Amyloid plaques in the brain has long been associated with cognitive decline, the hallmark of this devastating disease.

Overcoming Diagnostic Barriers

Currently, Alzheimer’s disease impacts over 6 million Americans and ranks as a leading cause of disability and death. Traditional diagnostic methods often rely on subjective evaluations or costly and invasive procedures such as amyloid positron emission tomography (PET) scans or cerebrospinal fluid (CSF) tests. These limitations often delay diagnosis until the disease reaches an advanced stage, hindering early intervention and effective treatment.

The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test addresses these challenges by offering a more accessible, automated diagnostic tool, utilizing Fujirebio’s widely available Lumipulse G1200 instrument system in clinical laboratories across the U.S. This new test complements the existing Lumipulse G β-Amyloid Ratio, previously authorized by the FDA for CSF applications in May 2022.

Quote from Leadership: The Need for Early Detection

“This innovation is pivotal in changing how Alzheimer's is diagnosed,” states Monte Wiltse, President and CEO of Fujirebio Diagnostics, Inc. “The absence of effective, accessible diagnostics has been a significant hurdle, contributing to late diagnoses and suboptimal treatment. Our goal is to empower healthcare providers and patients to diagnose Alzheimer’s early, allowing for timely and effective interventions.”

About Fujirebio: A Legacy of Diagnostic Excellence

Fujirebio is a globally recognized leader in high-quality in vitro diagnostics, with over 50 years of experience in producing reliable IVD products. Renowned for its pioneering work in cerebrospinal fluid biomarkers, Fujirebio remains dedicated to enhancing the field of neurodegenerative diagnostics through ongoing partnerships with clinical experts and organizations worldwide.

As the landscape of Alzheimer’s diagnostics takes a promising turn with the introduction of the Lumipulse G test, patients and healthcare providers alike await with anticipation the increase in early diagnostic capabilities that could result in better management of this challenging condition.

For more detailed information about Fujirebio and its Alzheimer’s diagnostic advancements, visit [www.fujirebio.com/alzheimer](http://www.fujirebio.com/alzheimer) and stay tuned for further updates on this and other innovative medical breakthroughs!