GE Healthcare’s DaTscan Ready for Parkinson’s

GE Healthcare today has announced the availability of DaTscan (Ioflupane I 123 Injection) in more than 80 hospitals across the United States. DaTscan is the first FDA-approved radiopharmaceutical adjunct imaging agent to help physicians evaluate patients with suspected parkinsonian syndromes (PS), such as Parkinson's disease (PD), the company says.

DaTscan is a radiopharmaceutical imaging agent that works by binding to dopamine transporters (DaT) in the brain. A specific marker for DaT, DaTscan produces images that provide visual evidence based on the density of dopamine transporters. The agent has been available in Europe since 2000 and has been used in nearly 300,000 patients in 34 countries. DaTscan is a Drug Enforcement Administration (DEA) Schedule II controlled substance, so hospitals and nuclear imaging centers that administer DaTscan must have infrastructure dedicated to quality control, handling and dispensing of DEA Schedule II, radioactive drugs used for diagnosis and treatment.

The National Parkinson Foundation estimates that 50,000 to 60,000 new cases of PD are diagnosed in the United States each year, but an accurate diagnosis can take up to six years. Many mistakenly attribute the first symptoms of PS, such as PD, to the normal aging process, and many have misconceptions about diagnosis.

In the absence of an effective blood test for PD, DaTscan may be used as an adjunct to other clinical evaluations to assist in differentiating PS from conditions with similar symptoms, such as essential tremor, in patients with suspected PS. DaTscan was not designed to differentiate between different forms of PS, the company says.The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.

FDA approval was based on two phase 3 clinical trials confirming the efficacy of DaTscan for the visualization of DaT distribution within the striata, an interior part of the brain. These studies, evaluating 284 adult patients with tremor, demonstrated the consistent performance of DaTscan in the visual detection of DaT distribution in the brain when compared with a reference clinical diagnosis.

"This new, innovative imaging agent is a big step in the right direction to be able to provide people with the right treatment and appropriate disease management," said Joyce Oberdorf, President and CEO, National Parkinson Foundation.