Diagnostic test being developed to measure clumped protein fragments in human cerebral spinal fluid

Mississauga, ON – Amorfix Life Sciences says it has developed a new diagnostic test that is able to measure clumped protein fragments, called aggregated beta amyloid, in human cerebral spinal fluid which may indicate the presence of Alzheimer’s disease and will make it easier to accurately diagnose the disease.

Currently, the only definitive diagnosis for Alzheimer’s is a post-mortem examination of brain tissue to identify the presence of the proteins that lead to plaque formation around neurons in the brain, believed to cause the symptoms of the disease. The Amorfix test is conducted on the cerebral spinal fluid from living patients, representing a significant step forward in early detection and subsequent treatment of the disease.

“Our hope is to one day be able to use this test on patients showing early signs of dementia in order to predict which patients may progress rapidly into the disease and which may not,” said Dr Robert Gundel, Amorfix’s president and chief executive officer. “Being able to accurately determine who has the disease will also facilitate new research in the area and will greatly enhance the quality of clinical trials for new treatments being developed,” he said.

Preliminary results suggest that the company’s newly-developed test can detect the presence of the aggregated beta amyloid in the cerebral spinal fluid which is collected when investigating patients for Alzheimer’s. The next step is to optimize the test for commercialization by comparing hundreds of spinal fluid samples from patients with the disease to those from age-matched individuals without the disease.

The first application of the test will be in the area of research, where it could be used to more effectively screen patients who participate in clinical trials. The current methodology to test for Alzheimer’s includes cognitive testing of memory and can have as much as a 30 to 35 per cent false positive result, he says.

“That means clinicians are potentially enrolling a significant number of subjects in their studies who don’t really have the disease they are trying to treat and that makes it very difficult to determine how well your drug is working,” he said. “An accurate diagnostic test like the one we’re developing can dramatically facilitate research and development efforts and hopefully get new treatments out on the market sooner at a lower cost.”