A Transformative Step Toward Accessible Alzheimer’s Diagnosis

On Friday, the FDA approved the first-ever blood test to aid in the diagnosis of Alzheimer’s disease. This is a long-awaited milestone in how we detect and manage one of the most devastating diseases of our time.

The Lumipulse G β-Amyloid 1-42/Phospho-Tau 217 Plasma Ratio test analyzes plasma biomarkers associated with Alzheimer’s pathology. It’s approved for use in adults 55 and older who are being evaluated for cognitive decline, and provides clinicians with additional insight into the biological hallmarks of the disease.

Until now, Alzheimer’s diagnosis has relied heavily on PET imaging or CSF analysis via lumbar puncture. These methods are costly, complex, and invasive, making them inaccessible to many who could benefit from an early diagnosis. 

This blood test represents a leap forward in diagnostic equity, making early testing more accessible. It will also enable more patients to receive disease-modifying treatments, which hinge on accurate and timely diagnosis. Hilarity for Charity extends its gratitude and congratulations to our partners and colleagues who have dedicated their expertise to achieving this milestone. 

At HFC, our work is rooted in expanding access to education, care, and innovation. This breakthrough underscores the importance of investing in technologies that meet people where they are, especially historically marginalized and underdiagnosed communities disproportionately affected by Alzheimer's disease.

We are optimistic about the doors this approval opens for families, researchers, and for our collective efforts to transform the Alzheimer’s landscape.

Sincerely,