FDA Approves Blood test to Aid AlzheimerS Diagnosis in Primary Care
Teh Food and Drug Administration (FDA) has approved a new blood test, Elecsys pTau181, developed by Roche in collaboration with Eli Lilly, designed to help rule out Alzheimer’s disease pathology directly within primary care settings. this represents a notable shift from previous diagnostic methods like positron emission tomography (PET) scans and cerebrospinal fluid (CSF) analysis,which are costly,invasive,and typically limited to specialist centers.
The Elecsys pTau181 test measures the concentration of phosphorylated tau protein (pTau181) in blood plasma – a biomarker strongly linked to amyloid and tau pathologies in the brain. Its primary function is to provide a high degree of certainty in excluding Alzheimer’s-associated pathology in individuals aged 55 and over experiencing initial cognitive symptoms, streamlining referrals to specialists.
A multicenter study involving 312 participants demonstrated a negative predictive value (NPV) of 97.9% for the test in a typical primary care cohort. This means a negative result strongly suggests the absence of amyloid pathology characteristic of Alzheimer’s disease.
The test’s accessibility is enhanced by its seamless integration into over 4,500 existing Roche diagnostic systems, minimizing technical hurdles for implementation in existing laboratories. this broad access aims to improve early detection and more targeted patient care.Primary care physicians can now more efficiently assess cognitive complaints, reducing needless specialist referrals and allowing neurologists to focus on patients with a higher likelihood of alzheimer’s.
Furthermore, the Elecsys pTau181 test has the potential to reduce the need for invasive and expensive procedures like PET scans and CSF analysis, lessening the burden on patients.
While the Elecsys pTau181 test effectively rules out Alzheimer’s pathology, another recently FDA-approved test, Lumipulse G pTau217/β-Amyloid 1-42, detects amyloid plaques in the brain. Both tests are available for adults aged 55 and over with cognitive symptoms.
Along with FDA approval in the United States, Roche has also received CE marking in Europe for the Elecsys pTau181 test, making it the first blood test certified under the In Vitro Diagnostics regulation (IVDR) for excluding Alzheimer’s-associated amyloid pathology.
