Overview
- Roche reports a 97.9% negative predictive value for Elecsys in a 312-participant study, indicating strong performance for ruling out Alzheimer’s pathology.
- A positive result is intended to trigger follow-up testing with CSF analysis or PET imaging, and experts caution against relying on a single biomarker.
- Roche says about 4,500 of its instruments are already installed in U.S. clinical laboratories, enabling rapid integration of the assay.
- This is the second FDA-cleared plasma biomarker test for Alzheimer’s this year, following Fujirebio’s May clearance for a different pTau217/β-amyloid ratio approach.
- Analysts and clinicians say easier blood testing could accelerate assessments and facilitate access to treatments such as Leqembi and Kisunla.