FDA grants fast-track designation to injectable positron emission tomography diagnostic

The FDA has granted fast-track designation to an investigational tau positron emission tomography diagnostic that can be used for a range of neurodegenerative conditions, according to the manufacturer.

Life Molecular Imaging (LMI) said in a press release that [18F]PI-2620 is an injectable imaging agent developed in concert with its research partner AC Immune SA, and is currently in phase 3 clinical development.

Tau proteins are a telltale biomarker of neurodegenerative conditions, primarily Alzheimer’s disease (AD); however, LMI said it plans to utilize the novel technology to enhance diagnosis and patient care for other conditions such as progressive supranuclear palsy, corticobasal degeneration and frontotemporal lobar dementia.

In a concurrent release, AC Immune SA said the diagnostic could provide an imaging window between 30 and 90 minutes after injection for AD diagnoses.

“This designation not only validates our approach but also facilitates closer collaboration with the FDA to expedite the development of [18F]PI-2620,” Andrew Stephens, chief medical officer at LMI, said in the release. “We are committed to advancing this important imaging agent with the potential to make a meaningful difference for patients who need accurate and accessible tau PET imaging.”