GE HealthCare’s MIM Software announces FDA Clearance of new Centiloid scaling tool to quantify amyloid plaque in brain imaging

Sep 17, 2024

CHICAGO — GE HealthCare’s MIM Software (Nasdaq: GEHC) today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to perform Centiloid scaling for positron emission tomography (PET)-based amyloid imaging analysis and quantification.[i]  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’s disease pathology.

Every three seconds, someone in the world develops dementia – with Alzheimer's disease accounting for 60-80 percent of dementia cases.[ii] In the U.S. alone, more than 6 million people are living with Alzheimer's, and by 2050, this number is projected to reach nearly 13 million.[iii] The condition affects memory, thinking and behavior, and symptoms typically start with mild cognitive impairment and eventually grow severe enough to interfere with daily tasks.[iv]

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’s – offering new hope to patients and their families.[v]

“Alzheimer’s 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 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.”  

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.[vi] 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’s.[vi]

GE HealthCare’s MIM Software now offers MIMneuro with Centiloid scaling, leveraging an automated workflow to help guide users through generating and understanding the quantitative result. The software 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's 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 Software’s new Centiloid scaling solution in MIMneuro is the latest addition to our growing portfolio of GE HealthCare Alzheimer’s 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.”

MIMneuro with Centiloid scaling is the latest addition to GE HealthCare’s comprehensive suite of products and solutions which span the Alzheimer’s disease care pathway from diagnosis through treatment monitoring. GE HealthCare is committed to creating a world where healthcare has no limits – one that works for patients and providers, ensuring access for all. This future state requires a broad collaboration between therapeutic and diagnostic industries with physicians, scientists, governments, payors, and most importantly, with patients.

Visit MIMSoftware.com for more information on MIMneuro and GEHealthCare.com to learn more about the company’s additional Alzheimer’s disease care pathway offerings. MIMneuro will also be showcased at the following global conferences:

• September 19-21, 2024: Society of Nuclear Medicine & Molecular Imaging Therapeutics Conference in Bethesda, Maryland, USA

• October 19-23, 2024: Congress of the European Association of Nuclear Medicine in Hamburg, Germany

• December 1-4, 2024: Radiological Society of North America Annual Meeting in Chicago, Illinois, USA

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[i] Centiloid scaling is 510(k) cleared by the U.S. FDA and commercially available in the U.S. Not available for sale in all regions. Not commercially available in all markets.

[ii] Alzheimer’s Association. What is Alzheimer’s Disease? Available here: https://www.alz.org/alzheimers-dementia/what-is-alzheimers

[iii] Alzheimer’s Association. Facts and figures. Available here: https://www.alz.org/alzheimers-dementia/facts-figures

[iv] Alzheimer’s Association. What is Alzheimer’s Disease? Available here: https://www.alz.org/alzheimers-dementia/what-is-alzheimers

[v] Alzheimer’s Association. Treatment and Research. Available here: https://www.alz.org/help-support/i-have-alz/treatments-research

[vi] Klunk WE, Koeppe RA, Price JC, Benzinger TL, Devous MD Sr, Jagust WJ, Johnson KA, Mathis CA, Minhas D, Pontecorvo MJ, Rowe CC, Skovronsky DM, Mintun MA. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015 Jan;11(1):1-15.e1-4. doi: 10.1016/j.jalz.2014.07.003.