GE's DaTscan gets European nod

GE Healthcare's SPECT radiopharmaceutical agent DaTscan has been recommended in updated European Federation of Neurological Societies (EFNS) guidelines for the diagnosis and management of Alzheimer's disease.

The guidelines, which appear in the October issue of the European Journal of Neurology, note that SPECT "may increase diagnostic confidence in the evaluation of dementia." The study added that dopaminergic SPECT imaging with DaTscan is useful in differentiating Alzheimer's from dementia with Lewy bodies (DLB), a neurological condition that is similar to Alzheimer's in that it results from the death of nerve cells in the brain.

The EFNS recommendation carries a level A grade of evidence -- the strongest grade assigned in the guidelines -- noting that DaTscan can differentiate Alzheimer's from DLB with sensitivity and specificity of "around 85%."

DaTscan is currently licensed and distributed in 32 countries, and it has been in clinical use for 10 years in more than 300,000 patients worldwide, according to the Chalfont St. Giles, U.K.-based vendor.

GE submitted a new drug application to the U.S. Food and Drug Administration (FDA) in March 2009 for DaTscan for striatal dopamine transporter (DaT) visualization in the brains of adult patients with suspected Parkinsonian syndrome.

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