BERLIN, June 15, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) is pleased to announce the publication of a significant retrospective analysis utilizing the amyloid positron emission tomography (PET) tracer, NeuraCeq® (florbetaben18F). The study's findings demonstrate the robust and homogeneous performance of quantitative methods, employing both CE marked software and other widely available processing tools. These quantitative methods provide comparable results to visual assessments of NeuraCeq® (florbetaben18F) PET scans. Importantly, excellent diagnostic efficacy was demonstrated when compared to histopathology assessment, with a mean sensitivity of 96.1% and specificity of 96.9% across all software packages.

As a result of these compelling findings, an updated label for NeuraCeq® was approved for use of PET scan quantification as an adjunct to visual assessment in the European Union (EU) and the United Kingdom (UK). The Committee for Medicinal Products for Human Use (CHMP) considered the use of approved CE marked software for quantitation appropriate to provide supplemental information when the reading physician requires further assistance in guiding the image assessment. In response to this update, LMI has provided amended educational materials in major EU markets, which include an additional module on the use of NeuraCeq® PET quantification as an adjunct to visual assessment.

Dr. Ludger Dinkelborg, CEO of Life Molecular Imaging, expressed the significance of these findings by stating, "Anti-amyloid therapies are on the horizon and highlight the importance of an early and accurate diagnosis in Alzheimer's disease (AD). Amyloid PET has played a pivotal role in the recent positive study outcomes for new AD drugs such as lecanemab and donanemab, by selectively including patients with confirmed amyloid pathology in the brain. The ability to quantify the amyloid burden opens up exciting avenues for the future. We are excited to have the adjunct use of quantification now included in our EU and UK labels."
Dr. Andrew Stephens, M.D., Ph.D., Chief Medical Officer at Life Molecular Imaging, also shared his enthusiasm, stating, "We are highly encouraged by the very homogeneous and robust data provided by all 15 quantification methods in this study. We are excited to offer updated educational materials in EU markets as part of our dedicated NeuraCeq® reader training program."

For further details regarding the published work, please visit https://link.springer.com/article/10.1007/s00259-023-06279-0

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