Amyloid

The early diagnosis and treatment of Alzheimer's

AppliedNeuroSolutions, a company focused on the development of products for the early diagnosis and treatment of Alzheimer's disease ("AD"), today announced an initiative to provide its P-Tau 231 cerebrospinal fluid (CSF) test to companies undertaking AD clinical trials. Potential customers, which include pharmaceutical, biotechnology and imaging companies, may use the P-Tau 231 test to aid in screening patients for clinical trials and to track P-Tau 231 levels pre- and post-drug treatment. Applied NeuroSolutions has identified over 50 companies with 100 plus compounds in active clinical development for AD. Revenue generated from providing this service would help support the further development of Applied NeuroSolutions's diagnostic pipeline, with a goal of delivering a serum-based test for the early diagnosis of AD.

The Company's P-Tau 231 test has been extensively researched and has overall sensitivity and specificity of 85% to 95%. This is based on a broad range of testing by US and international academic researchers to differentiate patients diagnosed with AD from patients diagnosed with other forms of dementia and other relevant neurological diseases, including major depression, as well as age-matched healthy controls. The data generated from over 2,000 CSF samples have been published in 21 peer-reviewed articles in leading neurology and other scientific journals.

In addition, Applied NeuroSolutions, has to date used the P-Tau 231 test to analyze over 1,500 samples for leading global pharmaceutical companies and is now offering this service to additional customers in response to the growing number of clinical trials to develop better solutions for the increasing AD population. Given the substantial investment required to conduct clinical trials, collection of information provided by the P-Tau 231 test can offer a cost- effective tool to optimize companies' AD drug development programs.

According to Dr. Mony de Leon, Professor of Psychiatry and Director Center for Brain Health at NYU School of Medicine "P-Tau 231 is now a validated biomarker of neurofibrillary-tangles, a hallmark pathology of Alzheimer's disease. Among all of the potential AD biomarkers, P-Tau 231 has consistently been the most successful in the diagnosis of AD, not only in the differential diagnosis of Alzheimer's disease in contrast to other dementias, but also in the very important early stages before the clinical manifestation of AD where the opportunity for therapeutic impact is greatest." ..http://www.medicalnewstoday.com