FDA Clears Centiloid Scaling Tool to Quantify Amyloid Plaque in PET Imaging
GE HealthCare’s MIM Software announced FDA 510(k) clearance to perform Centiloid scaling for positron emission tomography (PET)-based amyloid imaging analysis and quantification. Available with MIMneuro – a vendor-neutral solution – this new Centiloid scale tool aims to help clinicians more confidently determine the density of amyloid plaque in a patient’s brain. Amyloid plaque density is one component of Alzheimer disease pathology.
A hallmark of this disease is the accumulation of beta-amyloid protein in the brain, which is linked to cell death and tissue loss. Fortunately, in recent years, clinical results for amyloid-targeting treatments have demonstrated the potential to delay cognitive decline in some patients with Alzheimer – offering new hope to patients and their families.
“Alzheimer is a far-reaching disease that has been a challenge for our society, patients, caregivers, and healthcare systems for decades,” explains Andrew Nelson, CEO of MIM So ware, 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.”
PET imaging enables the visualization and quantification of amyloid protein to help clinicians identify candidates for amyloid-targeting treatments. To standardize quantitative amyloid imaging analysis across radiotracers and institutions, an international team of clinicians and researchers developed the Centiloid scale. This scale provides a standardized metric to compare amyloid results, with zero representing the average value from high-certainty amyloid-negative patients and 100 representing the average value from typical patients with Alzheimer.
GE HealthCare’s MIM So ware now offers MIMneuro with Centiloid scaling, leveraging an automated workflow to help guide users through generating and understanding the quantitative result. The so ware takes the PET amyloid images, provides clinicians instructions to automatically generate quantitative results, and presents the data in a standardized report for clinicians to review alongside the images. As a result, clinicians can more easily access the quantitative data they need to evaluate patients.
“As amyloid-targeting therapies continue to show meaningful results against Alzheimer disease, PET imaging can help clinicians more confidently determine a patient's amyloid status,” said Anja Mett, Global Product Leader, MI Neurology, GE HealthCare. “MIM So ware’s new Centiloid scaling solution in MIMneuro is the latest addition to our growing portfolio of GE HealthCare Alzheimer disease care pathway solutions: including MR and PET scanners, and our amyloid PET tracer - combined with our digital solutions. Altogether, we are uniquely positioned to provide integrated solutions to our customers in this highly regulated industry, with the potential to support strong procedure growth and the overall growth in diagnostic and molecular imaging.”