DIAGNOSTIC PROGRAM Alzheimer’s disease, at present, can be conclusively diagnosed only by histological examination of the brain by biopsy or autopsy.  The diagnosis of patients suspected of having AD is therefore typically made through a process of elimination, by conducting neurological and psychiatric examinations, extensive laboratory tests and a brain scan to rule out other conditions (such as stroke, brain tumor, or depression) with similar symptoms.  The definitive AD predictive accuracy of such exams is generally in the range of 70-80%.  Costs to patients for such testing currently runs anywhere from $1,000 - $5,000, and the testing often takes up to six months.  A simple, predictive, accurate, timely and cost effective diagnostic assay would therefore meet a tremendous medical need. Applied NeuroSolutions has completed the development of a diagnostic assay utilizing cerebrospinal fluid (CSF).  To date, the Company has completed numerous studies comprising in excess of 2,500 CSF samples utilizing this assay.  These studies were performed with blinded patient samples and were designed to test the assay’s ability to differentiate patients diagnosed with AD from patients diagnosed with other forms of dementia and relevant neurological diseases, including major depression, as well as healthy controls.  These studies have shown the ability of the assay to correctly identify the patients diagnosed with AD with an overall sensitivity and specificity in the 85% to 95% range.  The studies have been published in peer reviewed scientific journals such as Neuroscience Letters, Archives of Neurology, Annals of Neurology, Archives of General Psychiatry, Journal of Internal Medicine, Neurobiology of Aging, Neurology, and American Journal of Psychiatry. These data suggest that phosphotau may represent an excellent biochemical marker for AD.  It detects a characteristic feature of pathophysiology, may allow one to track disease progression and accurately discriminates between AD patients and neurological controls.  Several pharmaceutical companies have utilized the Company’s CSF phosphotau assay as a biomarker in the clinical development of therapeutics to treat AD.  Our most recent research has sought to further substantiate the utility of the test in the mild cognitive impairment (MCI) population, as evidenced by reports published in Neurobiology of Aging in September 2007, Neurology in December 2007 and Journal of Alzheimer’s Disease in February 2009. We are utilizing the knowledge gained during the development of our CSF-based diagnostic test to develop two types of serum-based tests to detect Alzheimer’s disease: one to “rule out” AD and one, utilizing the Company’s P-Tau 231 biomarker and other methods, to support the diagnosis of AD. In July 2009 we announced we had achieved feasibility in our development of a serum-based test related to the diagnosis of patients with AD.  The results of two limited studies, which provided data from blinded serum samples, showed the ability of this tau-based test to differentiate between patients with AD and normal controls.  Our focus is on advancing the development of a blood-based test for AD to commercialization, by selling through reference labs under the Clinical Laboratory Improvement Amendment of 1988 (CLIA), and to pharma and biotech companies for use in their drug development efforts and clinical trial screening.