Inverness Medical Innovations Inc. and a research institute based in Morgantown, W.Va., are partnering up to develop and commercialize a diagnostic test for Alzheimer’s disease.
The Waltham-based diagnostics manufacturer will fund research and development of a test developed by researchers at the Blanchette Rockefeller Neurosciences Institute for three years, in exchange for the right to market the test once it’s ready — which could be as soon as 18 months, The Associated Press reports.
The disease is a fatal brain condition that progessively destroys brain cells, interfering with memory, thinking and behavior. As many as 5.3 million Americans have the disease, which is famously difficult to diagnose.
That’s because the diagnosis is based on observing patients’ behavior and ruling out other possible causes for dementia. In fact, diagnosis can only be definitively confirmed after autopsy, which reveals Alzheimer’s distinctive pattern of brain damage.
The test discovered at BRNI would be the first to provide definitive early detection of the disease and could radically alter the way it’s treated. It works by identifying the abnormal function of Protein kinase C, a group of enzymes involved in cell signaling systems. A small skin sample taken at a doctor’s office is cultured at the institute and then stimulated to develop the PKC enzymes. If too much phosphorous combines with the PKC group in the skin cells, the patient has Alzheimer’s.
In a trial of more than 300 patients at 15 hospitals, including 42 autopsy-confirmed cases, the test was 98 percent accurate on the autopsied patients, including 11 with early-stage Alzheimer’s.