Roche and Eli Lilly have announced that their jointly developed Elecsys Amyloid Plasma Panel (EAPP), a blood test designed for the early detection of Alzheimer's disease, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation is intended to accelerate the development, assessment, and review of medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.
The Elecsys Amyloid Plasma Panel detects phosphorylated tau proteins, specifically pTau-217, which accumulate in the brain and are indicative of Alzheimer's disease. The test offers a non-invasive alternative to current diagnostic methods, which typically involve PET scans, CT scans, or cerebrospinal fluid (CSF) analysis obtained through lumbar puncture. These methods are often time-consuming, expensive, and not readily accessible, leading to delayed or missed diagnoses for many individuals.
Significance of Early Diagnosis
Early diagnosis of Alzheimer's is crucial for several reasons. As the global population ages, the number of people living with dementia is projected to reach 152 million by 2050, placing immense strain on healthcare infrastructure. Early diagnosis allows for timely intervention with available therapies to slow symptom progression and improve patient outcomes. Furthermore, it facilitates the identification of suitable candidates for clinical trials of novel Alzheimer's treatments.
"The incidence of dementia is growing worldwide, with 75% of cases remaining undiagnosed," said Matt Sause, CEO of Roche Diagnostics. "Consequently, there is a critical role for diagnostics to play in addressing this global health challenge. We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease."
The Role of pTau-217
Phosphorylated tau proteins, particularly pTau-217, have emerged as promising biomarkers for Alzheimer's disease. Studies have shown that pTau-217 can differentiate Alzheimer's from other neurodegenerative disorders and potentially detect elevated risk of the disease years before symptoms manifest. The 'tau hypothesis' posits that abnormal tau proteins aggregate in the brain, forming tangles inside nerve cells, ultimately disrupting neuronal transport systems. These tau proteins can be detected in the blood, making them accessible through blood-based assays.
Comparison to Existing Methods
Currently, Alzheimer's diagnosis relies on a combination of cognitive testing, PET scans, and CSF analysis. However, access to PET scans is limited, and CSF analysis is invasive. The Elecsys Amyloid Plasma Panel offers a less invasive and more accessible alternative, potentially reducing the demand for follow-up testing by around 80%, as suggested by research on similar pTau217 tests.
Future Directions
Roche and Lilly are also developing another Elecsys test that measures pTau181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma, which has also been granted breakthrough status by the FDA. These advancements in blood-based diagnostics hold promise for transforming Alzheimer's disease management by enabling earlier and more accurate diagnoses, facilitating timely interventions, and accelerating the development of new therapies.
