FDA clears NeuroQuant PET, software that converts amyloid PET results to a common scale

FDA clears NeuroQuant PET, software that converts amyloid PET results to a common scale

On August 12, the FDA issued a “Substantially Equivalent” decision for NeuroQuant PET under submission K261916. On August 18, the developer, Cortechs.ai, announced the decision in a press release. The software automatically generates quantitative amyloid PET reports for patients with cognitive impairment and other neurological conditions.

Amyloid PET shows where a tracer, a labeled substance that binds to amyloid deposits, accumulates in the brain. However, the resulting value depends on the tracer, scan timing, scanner, and calculation method. This makes it difficult to compare results across studies and clinics.

The Centiloid scale converts these results into common units. A value of zero corresponds to the mean in young people who can be classified with high confidence as amyloid negative, while 100 corresponds to the mean in typical patients with Alzheimer’s disease. This allows values obtained with different tracers and analysis methods to be compared across sites and between studies conducted at different times.

NeuroQuant PET performs this conversion on a completed scan. The software identifies brain regions, calculates SUVr, the ratio of tracer uptake in the target region to uptake in a reference region, and adds the Centiloid value to a structured report. Cortechs.ai states that the FDA clearance covers amyloid reports for flutemetamol, florbetaben, and florbetapir.

A scale developed to compare research findings is becoming part of an automated clinical report. The scan is supplemented by a value that can be interpreted consistently across different tracers and analysis methods.