GE Healthcare recently announced that it has gained 510(k) clearance for a new diagnostic tool aimed at aiding in the assessment of Alzheimer’s disease. This tool incorporates a Centiloid scale into GE Healthcare’s Mim software, enhancing the ability of clinicians to quantify the density of amyloid plaque from PET scans in patients’ brains. Amyloid plaques, composed of protein, are significant in Alzheimer’s disease as their accumulation is linked to detrimental symptoms such as memory loss.
The Centiloid scale, pivotal in this new tool, was developed to normalize measurements of amyloid imaging. This standardized scale, ranging from zero to 100, provides a metric where zero corresponds to average values from amyloid-negative patients and 100 aligns with the average values from typical Alzheimer’s patients. This standardization is crucial, given the variable results in PET tracer retention reported across different medical facilities prior to its development in 2015.
Amyloid plaques and their detection have gained importance following the introduction of drugs targeting these plaques in Alzheimer’s treatment. The increasing relevance of such medications aligns with the recent policy changes by the Centers for Medicare and Medicaid Services, which have improved the accessibility of PET scans in Alzheimer’s assessment.
GE’s acquisition of Mim Software in April enhanced its capability in amyloid imaging, as it added amyloid imaging support software to its portfolio. This acquisition led to the integration of the Centiloid scale into the vendor-neutral software Mimneuro, used in PET scanners. Mimneuro delivers a workflow that produces standardized tracer uptake values for targeted brain regions and compiles these in a report format for clinicians. Although GE Healthcare owns Mimneuro, the software is compatible with PET tracers from various suppliers, including GE’s own Vizamyl, Lilly’s Amyvid, and Life Molecular Imaging’s Neuraceq.
Despite current sales of Vizamyl labeled as “a few million dollars,” James Saccaro, CFO of GE Healthcare, indicated on an earnings call that the company anticipates revenue growth driven by the increasing adoption of Alzheimer’s therapies. In addition to selling PET scanners, the integration of Mimneuro into GE Healthcare’s offerings not only expands its exposure to the growing Alzheimer’s market but also positions the company to benefit from sales even when clinicians opt for PET products from other vendors.
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