Roche and Labcorp Lead Alzheimer's Diagnostic Revolution with FDA-Cleared Blood Test

In a significant advancement for Alzheimer's disease diagnostics, Roche has secured FDA clearance for its Elecsys pTau181 blood test, developed in collaboration with Eli Lilly. This minimally invasive test, designed for use in primary care settings, aims to assess early signs of Alzheimer's and other causes of cognitive decline in patients 55 years and older.

Expanding Accessibility in Primary Care

The Elecsys pTau181 test marks a pivotal shift in Alzheimer's diagnostics by bringing blood-based biomarker testing into the primary care arena. Unlike previous tests limited to specialized care settings, Roche's Elecsys can be administered by primary care physicians, significantly broadening access to early detection.

Labcorp, a leading diagnostic laboratory, has announced plans to offer the Elecsys pTau181 test nationwide starting early next year. This move is expected to enhance the test's availability across the United States, potentially benefiting millions of patients.

Technical Advancements and Clinical Significance

The Elecsys test measures levels of phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer's pathology, including amyloid plaque and tau aggregate pathology. In clinical studies involving over 300 patients, the test demonstrated a 97.9% negative predictive value in ruling out Alzheimer's pathology.

Dr. Brian Caveney, Labcorp's chief medical and scientific officer, emphasized the test's importance: "Many patients presenting with cognitive symptoms don't have Alzheimer's disease, so helping clinicians rule it out can be just as critical as confirming it."

Implications for Alzheimer's Treatment Landscape

The approval of Elecsys could potentially boost the uptake of currently approved Alzheimer's therapies, such as Biogen and Eisai's Leqembi. Chris Viehbacher, CEO of Biogen, noted that biomarker-based tests like Elecsys could "remove some of the bottlenecks" in treatment uptake.

This diagnostic advancement comes amid a series of regulatory wins in the Alzheimer's space, including the recent approval of Biogen and Eisai's subcutaneous Leqembi (branded as Leqembi Iqlik) and Eli Lilly's Kisunla, which secured a label expansion for a more gradual dosing schedule.