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Monday, January 27, 2025

FDA Grants Quick Observe Designation to Rising Tau PET Imaging Agent


A brand new tau positron emission tomography (PET) imaging agent that will facilitate diagnostic insights into the event of Alzheimer’s illness, progressive supranuclear palsy and corticobasal degeneration has garnered a quick monitor designation from the Meals and Drug Administration (FDA).

The injectable (18F)PI-2620 agent, which is at present in a section 3 trial for diagnosing tau pathology related to Alzheimer’s illness, targets tau neurofibrillary tangles, in accordance with Life Molecular Imaging, the developer of the PET agent.

Providing enhanced imaging of tau neurofibrillary tangles, the rising PET agent (18F)PI-2620 has garnered quick monitor designation standing from the FDA for detecting the development of three neurodegenerative situations together with Alzheimer’s illness. (Photographs courtesy of Life Molecular Imaging.)

Emphasizing the (18F)PI-2620 agent’s mixture of “strong” uptake within the mind and fast wash-out in non-targeted mind areas, Life Molecular Imaging mentioned the agent facilitates early detection and quantification of tau deposition within the mind.

“Receiving quick monitor designation from the FDA is a serious milestone that highlights the promise of (18F)PI-2620 in addressing the crucial want for efficient diagnostic instruments in Alzheimer’s illness, progressive supranuclear palsy, and corticobasal degeneration,” mentioned Andrew Stephens, the chief medical officer at Life Molecular Imaging. ” … We’re dedicated to advancing this necessary imaging agent with the potential to make a significant distinction for sufferers who want correct and accessible tau PET imaging.”

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