FDA Advances Development Of Alzheimer’s Blood Test

Fierce Biotech reports:

After more than a year in the works, Roche and Eli Lilly have taken a step closer to delivering their blood test designed to aid in the diagnosis of earlier cases of Alzheimer’s disease. The FDA has granted their work a breakthrough designation to help accelerate its development.

Roche’s Elecsys plasma assay searches for and quantifies phosphorylated fragments of the brain protein tau, known as pTau-217, with the goal of capturing a biomarker that can distinguish Alzheimer’s from other neurodegenerative disorders.

According to the company, a patient’s positive result would correlate with a high likelihood of finding Alzheimer’s characteristic amyloid plaques through a PET scan or an analysis of their cerebrospinal fluid while a negative finding would help to rule the possibility out.

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#MEDIA: We are pleased to announce that @FDA granted Breakthrough Device Designation of our blood test to support earlier #Alzheimer‘s disease diagnosis.
Learn more here: https://t.co/sAPTHrlDTV $ROG $RHHBY pic.twitter.com/tmzERJwzTQ

— Roche (@Roche) April 11, 2024

Latest on #Alzheimers: https://t.co/JstjzaWCor Alzheimer’s blood test from Roche & Eli Lilly nabs FDA breakthrough tag – Fierce Biotech #Alzheimeric #d… #Alzheimeric

— Alzheimeric (@Alzheimeric) April 11, 2024