Amorfix Life Sciences demonstrates ground-breaking accuracy in testing for early onset of Alzheimer’s disease
Mississauga, Ontario – October 6, 2011 – Amorfix Life Sciences is one step closer to getting a highly accurate test for Alzheimer’s disease into the hands of neurologists after announcing that its breakthrough diagnostic test – announced in January of this year – has achieved close to 90 per cent sensitivity and specificity, thereby minimizing the potential for false positive and false negative results.
“Right now, diagnostic accuracy for Alzheimer’s disease can be as low as 70 per cent, meaning three out of 10 people who are diagnosed with this disease might not actually have Alzheimer’s disease, but rather some other kind of dementia,” explains Dr. Robert Gundel, Amorfix President and Chief Executive Officer. “With our test, we’ve potentially reduced this percentage down to one out of 10 people.”
“What this means is that we’ve moved one step closer towards commercialization of a highly accurate diagnostic test for Alzheimer’s disease. Neurologists need a better way of diagnosing this devastating disease” notes Gundel, adding that the first application for the diagnostic test will be to more precisely screen patients for participation in clinical trials, leading to improved results and ultimately reducing the time and cost associated with ongoing study of the disease.
“The more accurate researchers can be in terms of getting the right patient population into a study, the more accurate their results are going to be in determining whether or not a specific drug or course of treatment is working,” he explains.
Currently, the only definitive diagnosis for Alzheimer’s disease is a post-mortem examination of brain tissue to identify the presence of the aggregated beta amyloid protein in the form of plaques in the brain. The Amorfix test is conducted on cerebrospinal fluid obtained from living patients, representing a significant step forward in early detection and subsequent treatment of the disease.
Next steps include securing a development partner that has the expertise and resources to assist in taking the Amorfix assay to market. The ultimate goal, says Gundel, is to develop a commercial version that can be used to diagnose Alzheimer’s disease in patients who exhibit mild cognitive impairment, enabling early intervention before the disease progresses to frank Alzheimer’s. This is extremely important because the number of people with Alzheimer’s disease is expected to increase significantly over the next 20 to 30 years, he says, adding that although there are currently few treatment options for patients with Alzheimer’s disease, the earlier one can identify the problem, the better chance there is of significantly delaying disease progression.
“When a patient comes into a neurologist’s office showing symptoms of dementia, the evaluation frequently includes obtaining a sample of cerebrospinal fluid,” Gundel says. “With the addition of our test, the accuracy of that diagnostic process will be close to 90 per cent, which is well beyond what it is now.”
Alzheimer’s disease affects more than five million people across North America and that number is expected to grow as the population ages. This breakthrough by Amorfix represents an important development in furthering the early detection and subsequent treatment of the disease. In the future, the company plans to further adapt this test for use as a routine diagnostic blood test. “What we really want at the end of the day is a simple blood test that would totally revolutionize the way the disease is diagnosed and treated,” says Gundel, noting that Amorfix has already been successful in measuring aggregated beta amyloid in the blood of a number of animal models used for Alzheimer’s disease preclinical research. “We’re laying the groundwork for the development of a blood test for humans,” he says.
About Amorfix
Amorfix Life Sciences Ltd. is a product development company focused on diagnostics and therapeutics for misfolded protein diseases including Alzheimer’s disease, cancers and ALS. Amorfix applies its computational discovery platform, ProMIS™ to predict novel disease specific epitopes (DSEs) on the molecular surface of misfolded proteins. The company’s lead programs include therapeutics and companion diagnostics for cancers, antibodies and vaccines to DSEs in ALS and Alzheimer’s diagnostic tests. Its proprietary Epitope Protection™ technology also enables it to specifically identify very low levels of misfolded proteins in a biological sample. Amorfix’s diagnostic programs include an ultrasensitive method for the detection of aggregated beta-Amyloid in brain tissue, cerebral spinal fluid and blood from animal models of Alzheimer’s, months prior to observable amyloid formation and development of a human screening test. For more information about the company, visit www.amorfix.com.
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