The FDA has recently cleared innovative positron emission tomography (PET) imaging tools designed to improve the diagnosis, staging, and monitoring of Alzheimer's disease. These advancements include Centiloid scoring and tau PET quantification features for Siemens Healthineers' syngo.PET Cortical Analysis software, as well as Centiloid scaling for GE HealthCare's MIMneuro software.
Siemens Healthineers' syngo.PET Cortical Analysis
Siemens Healthineers' syngo.PET Cortical Analysis software has received FDA 510(k) clearance for two new features: Centiloid scoring and tau PET quantification. Centiloid scoring standardizes the measurement of beta-amyloid plaque, a hallmark of Alzheimer's disease, using a 100-point scale. This feature can be used with three different beta-amyloid PET radiopharmaceuticals approved for Alzheimer's detection. The tau PET quantification feature, when used with the radiopharmaceutical flortaucipir (Tauvid, Eli Lilly), allows for the quantification of tau protein tangle distribution and density in the brain.
"The ability to quantify the buildup of amyloid plaque and tau protein in the brains of Alzheimer’s disease patients can provide clinicians with important diagnostic and staging information pertaining to the disease," said Martin Cordell, PhD, director of product lifecycle management at Siemens Healthineers Molecular Imaging. He added that the new features fortify their portfolio for detection, diagnosis, monitoring, and follow-up related to Alzheimer’s disease.
Alzheimer's disease is characterized by the accumulation of both beta-amyloid plaques and tau protein tangles in the brain, leading to neurodegeneration and cognitive decline. The Centiloid scoring feature is particularly relevant given the recent FDA approval of new therapies designed to reduce cognitive decline by removing beta-amyloid from the brain. Standardizing beta-amyloid plaque measurements via PET is crucial for patient management and clinical trial design.
The tau PET quantification feature utilizes Braak staging, a six-stage model that classifies the progression of tau pathology in the brain. This staging correlates closely with cognitive impairment levels, with later stages indicating worse cognitive and clinical symptoms. Tau PET has played a significant role in amyloid-directed drug trials for patient stratification, drug management, and treatment response assessment. Several investigational tau-targeted therapies are currently in clinical development, further emphasizing the importance of tau PET quantification.
GE HealthCare's MIMneuro Software
GE HealthCare also announced that its MIM Software has received 510(k) clearance from the FDA for Centiloid scaling in its MIMneuro software. This vendor-neutral solution allows for the analysis and quantification of amyloid plaque density in the brain using PET imaging. The Centiloid scale provides a standardized measurement for amyloid plaque density, enabling clinicians to compare results across different imaging techniques and institutions.
MIMneuro simplifies PET image analysis through an automated workflow, generating quantitative results in a standardized report. This streamlined process empowers clinicians to make more informed decisions about patient care.
"Alzheimer’s is a far-reaching disease that has been a challenge for our society, patients, caregivers, and healthcare systems for decades," said Andrew Nelson, CEO of MIM Software, GE HealthCare. "Centiloid scaling with MIMneuro offers a standardized, quantitative metric to assist healthcare providers in confidently estimating amyloid plaque density, one key aspect of this debilitating disease. By increasing clinician confidence, we hope to ultimately expand patient access to cutting-edge, personalized care."
With the global prevalence of dementia increasing, accurate and standardized tools for early diagnosis are critical. These new FDA clearances represent significant advancements in the fight against Alzheimer's disease, providing clinicians with enhanced capabilities for diagnosis, staging, and monitoring of this devastating condition.
