GE HealthCare has received the US Food and Drug Administration (FDA) approval for an updated label for Vizamyl PET imaging agent, enhancing its use in beta-amyloid detection.
Vizamyl was initially approved in 2013 to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment.
The expanded FDA approval allows for quantitative analysis of Vizamyl scans, offering a more precise assessment of Alzheimer’s patients and better-informed care decisions.
Previously, Vizamyl and similar diagnostics provided only visual assessments of amyloid plaque accumulation in the brain.
With the inclusion of quantification feature, Vizamyl allows clinicians to objectively calculate amyloid load using specialised software.
GE HealthCare’s Pharmaceutical Diagnostics (PDx) division Chief Medical Officer Jit Saini said: “The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions.
“These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families, helping provide clearer answers, earlier diagnoses, and enabling more personalised treatment strategies.”
According to the research, the quantification feature improves diagnostic confidence and consistency among medical professionals.
The updated label also permits the use of Vizamyl to monitor effectiveness of the therapy, evaluating if amyloid plaques have been reduced to potentially discontinue treatment.
In addition, the new label includes an indication for selecting patients eligible for therapy and removes prior restrictions on diagnosing Alzheimer’s disease.
The expanded approval aligns with revised criteria from the Alzheimer’s Association, which state that an abnormal amyloid PET scan can establish a diagnosis.
The label also no longer limits predicting cognitive decline, as evidence links amyloid-positive scans to a higher risk of progression from early mild cognitive impairment.
GE HealthCare supports quantitative analysis of amyloid PET scans through its MIM Neuro Software platform, recently cleared by the FDA for centiloid scaling.
City of Hope National Medical Center Professor of Radiology, Section Chief of Nuclear Medicine and Director Theranostics Phillip Kuo said: “The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis.
“Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer’s disease and determining when it can be discontinued.”
