Vizamyl(TM) and Beta Amyloid Imaging
Vizamyl (Flutemetamol F18) is a radioactive tracer indicated for PET imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease or other causes of cognitive decline. Dementia associated with AD is related to multiple factors, including the accumulation of a protein called beta amyloid in the brain.
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Vizamyl is one of only three FDA-approved PET radiotracers available for detecting beta amyloid and is the only PET imaging tracer for detection of amyloid approved by FDA for visual interpretation of color images. Vizamyl is an adjunct to other diagnostic evaluations.
A negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. The most commonly reported adverse reactions in NDA clinical trials were flushing (2 percent) and increased blood pressure, headache, nausea and dizziness (at 1 percent each).
Image interpretation is performed independently of the patient's clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan. Motion artifacts may distort the image. Images should be interpreted only by readers who have completed a reader training program available from GE Healthcare.
About RadNet, Inc.
RadNet, Inc. is the leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 250 owned and/or operated outpatient-imaging centers (inclusive of 23 facilities held in joint ventures). RadNet's core markets include California, Delaware, Maryland, New Jersey, New York and Rhode Island. Together with affiliated radiologists, and inclusive of full-time and per diem employees and technologists, RadNet has a total of approximately 6,000 employees.
