GE HealthCare’s amyloid PET imaging agent Vizamyl (flutemetamol) has won an FDA nod for expanded indications on June 24, 2025. The specific update adds quantification and therapy monitoring capabilities that competing products currently lack, positioning the diagnostic as an enabler for the rapidly growing anti-amyloid therapy market. At present, there are two disease-modifying anti-amyloid therapies on the market: lecanemab (Leqembi) from Eisai and Biogen and donanemab (Kisunla) from Eli Lilly, which won FDA approval in July 2023 and July 2024, respectively.
While Alzheimer’s focused monoclonal antibodies brought in some $500 million in 2024, the market for anti-amyloid monoclonal antibodies is robust, estimated at $4.8 billion in 2024 and expected to grow at 16% annually through 2032¹. This explosive growth creates urgent demand for diagnostics that can identify eligible patients and track treatment response—functions now explicitly approved for Vizamyl.
The timing aligns with a shift in Alzheimer’s care. Anti-amyloid therapies like lecanemab and donanemab cost tens of thousands annually and carry significant risks, including Amyloid-Related Imaging Abnormalities (ARIA), a form of brain swelling. Healthcare systems thus grapple with the question of which patients have enough amyloid to justify treatment? An additionally, is the expensive therapy working, and when has amyloid been reduced enough to potentially stop?
What the label expansion enables
The label expansion enables two key capabilities. First, quantification transforms amyloid assessment from subjective visual interpretation to objective numerical measurement. Published research demonstrates quantification improves diagnostic confidence and consistency among readers, with validation studies showing an area under the curve greater than 0.94 for detecting amyloid positivity².
Previous label limitations were also removed, including those for diagnosing Alzheimer’s disease and predicting cognitive decline. This aligns with revised Alzheimer’s Association criteria that recognize an abnormal amyloid PET scan as sufficient for diagnosis.
Competitive positioning
An analysis of FDA labels shows Vizamyl now stands alone among amyloid PET agents with approved indications for both quantification and therapy monitoring. Competitors, including Lilly’s Amyvid (florbetapir), Piramal’s Neuraceq (florbetaben) and Lilly’s tau-targeting Tauvid (flortaucipir), lack these capabilities on their official labels.
While competitors could pursue similar label expansions, the clinical trial requirements and FDA review timelines grant Vizamyl a near-term advantage for these specific indications.
While specific Vizamyl revenue figures remain undisclosed, which is a standard practice for individual products within pharmaceutical portfolios, GE HealthCare’s broader Pharmaceutical Diagnostics (PDx) segment provides clues. The division delivered 9% growth in Q4 2024, with management guiding for similar performance in 2025.
Potential clinical impact of the FDA win
The shift to quantitative measurement addresses a challenge in amyloid imaging. In general, visual interpretations show sensitivity of 88-98%³, yet they can suffer from inter-reader variability. Quantification using standardized scales like the Centiloid scale provides objective thresholds (e.g., >20-25 Centiloids indicating positivity⁴). For therapy monitoring, quantitative PET offers objective evidence to help guide difficult treatment decisions.
Sources
- Datavagyanik Business Intelligence. (2025). Monoclonal Antibodies for Dementia (e.g., anti-amyloid antibodies) Market Size, Clinical Trials, Product Pipelines and Investment Trends, till 2032. Retrieved from https://www.openpr.com/news/4078024/monoclonal-antibodies-for-dementia-e-g-anti-amyloid
- Whittington, A., & Gunn, R. (2022). Quantification of amyloid PET for future clinical use: a state-of-the-art review. European Journal of Nuclear Medicine and Molecular Imaging, PMC9308604. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC9308604/
- Harn, N. R., et al. (2022). The Role of Amyloid PET in Imaging Neurodegenerative Disorders: A Review. Journal of Nuclear Medicine, PMC9165727. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC9165727/
- Leuzy, A., et al. (2020). Comparison of amyloid PET measured in Centiloid units with neuropathological findings in Alzheimer’s disease. Alzheimer’s Research & Therapy, 12, 22. Retrieved from https://alzres.biomedcentral.com/articles/10.1186/s13195-020-00587-5
- Additional validation from: Salvadó, G., et al. (2019). Centiloid cut-off values for optimal agreement between PET and CSF core AD biomarkers. Alzheimer’s Research & Therapy, 11, 27. Retrieved from https://alzres.biomedcentral.com/articles/10.1186/s13195-019-0478-z
- Expert consensus from: Expert opinion on Centiloid thresholds suitable for initiating anti-amyloid therapy. (2024). Alzheimer’s & Dementia, Retrieved from https://www.sciencedirect.com/science/article/pii/S2274580724006009
Filed Under: Neurological Disease
