Parkinson’s disease , like Alzheimer’s and some other progressive brain diseases, is difficult to diagnose because there’s no blood or lab test to determine who has it. Now, GE is hoping the FDA will approve its chemical for brain imaging, which the company says may help docs rule out the possibility that a patient has Parkinson’s. But the results still won’t provide a definitive diagnosis. The chemical, a so-called radiopharmaceutical with the brand name Datscan, is injected into patients to allow doctors to get a look at the brain. Specifically, it helps detect the loss of certain brain cells in the substantia nigra , which is known to be associated with Parkinson’s. An FDA panel of experts will weigh in tomorrow on GE’s quest to have the chemical approved for use in this country. (Read the FDA’s documents

about the agent here ). In Europe, where Datscan has been on the market since 2000, doctors have reportedly used the scan to rule out diagnoses of Parkinson’s in patients who show up with apparent symptoms of the disease but who don’t exhibit an abnormal brain scan, Don Black of GE told the Health Blog. When the imaging results are consistent with their clinical judgment, doctors may feel more comfortable making a diagnosis. Doctors in Europe estimate that such scans help in about 10% of cases, said Black. Dow Jones Newswires notes that the FDA is questioning the clinical data because it changes were made to the clinical studies from the original design but the FDA didn’t find any major safety problems with Datscan.

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GE, Brain Imaging and Diagnosing Parkinson’s Disease