FDA Approves Blood test to Aid AlzheimerS Diagnosisโ in Primary Care
Teh Food and Drug Administration (FDA) hasโ approved a new bloodโ test, Elecsys โฃpTau181, developed by Roche in collaboration with โขEli Lilly, designed โto help rule out Alzheimer’s disease pathology directly within primary care settings.โค this represents a notable shiftโ from previous diagnosticโ methods like positron emission tomography (PET) scans โคand cerebrospinal fluid (CSF) analysis,which โฃare costly,invasive,and typically limited to specialist centers.
The Elecsys โฃpTau181 test measures the concentration of phosphorylated tau proteinโ (pTau181) in blood plasma – a biomarker strongly linked to amyloid and tau pathologies in the brain. Its primary function is to provide a high โdegree of certainty in excluding Alzheimer’s-associated pathology in individuals aged 55 and over experiencing initial cognitive symptoms, streamlining โฃreferrals to specialists.
A multicenter study involving 312 participants demonstrated aโ negative predictive value (NPV) โof 97.9% for the testโข in a typical primary care cohort.โ This means a negative result strongly suggests the absence of amyloid pathology characteristic of Alzheimer’s disease. โ
The test’s accessibilityโ is enhanced by its seamless integration into over 4,500 existing Roche diagnostic systems, minimizingโ technicalโข hurdles for implementation in existing โคlaboratories. โคthis broad access aims to improve early detection and more targeted patient care.Primary โขcare โฃphysicians can now more efficientlyโฃ assess cognitive complaints, reducing needless specialist referrals andโค allowing neurologists to โfocus โฃon patients with a higher likelihood of alzheimer’s.
Furthermore, the โคElecsys pTau181 test has the potential to reduce the need for invasive โand expensive procedures like PET scans and CSF analysis, lessening the burden โon patients.
While the Elecsys pTau181 test โeffectively rules out Alzheimer’s pathology, another recently FDA-approved test, Lumipulse G pTau217/ฮฒ-Amyloid 1-42, detects amyloidโค plaques in the brain. Both tests are โavailable for adults aged 55 and over with cognitiveโฃ symptoms.
Along with โFDA 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 โunder the In Vitro Diagnostics regulationโ (IVDR) for excluding Alzheimer’s-associated amyloid pathology.
