Labcorp (NYSE: LH) has officially launched the Lumipulse® pTau-217/Beta Amyloid 42 Ratio test, the first in-vitro diagnostic (IVD) blood test for Alzheimer’s disease to receive FDA clearance. Developed by Fujirebio Diagnostics, Inc., the test is now available across the United States through Labcorp's expansive service network.
Advancing Diagnostic Capabilities for Alzheimer's Disease
This groundbreaking test identifies the presence of amyloid plaques through a simple blood draw, offering a diagnostic accuracy comparable to traditional CSF and PET scan methods. In clinical trials, it demonstrated:
- 92% positive predictive value
- 97% negative predictive value
What This Means for Lab Managers
The test is a major development for clinical and reference labs, providing:
- Operational Simplicity: Non-invasive blood collection reduces logistical burdens
- Improved Patient Access: Available at 2,200+ Labcorp Patient Service Centers
- Clinical Alignment: Supports recent guidelines from the Alzheimer’s Association recommending blood-based biomarkers in specialized care
Designed for Targeted Clinical Use
The Lumipulse test is intended for patients aged 50+ showing signs of cognitive decline and should be interpreted in conjunction with other clinical findings. It is not intended as a stand-alone diagnostic or screening tool.
By broadening access and enabling earlier diagnoses, Labcorp is setting a new benchmark for neurodegenerative disease testing.
Learn more at Labcorp's Neurology Diagnostics.
