Healthcare Industry News:  Alzheimer's 

Diagnostics Neurology

 News Release - July 25, 2007

Applied NeuroSolutions' P-Tau 231 Cerebrospinal Fluid Diagnostic Test Identified as a Reliable Biomarker for Alzheimer's Disease

First Proposed Diagnostic Criteria Change for Alzheimer's Disease Since 1984 Includes Cerebrospinal Fluid Biomarkers

VERNON HILLS, Ill.--(HSMN NewsFeed)--Applied NeuroSolutions, Inc. (OTC BB:APNS ; www.appliedneurosolutions.com), a Company focused on the development of an integrated product portfolio for the treatment and diagnosis of Alzheimer's disease (AD), today reported that a Position Paper, "Research Criteria for the Diagnosis of Alzheimer's Disease: Revising the NINCDS-ADRDA Criteria", was recently published on The Lancet's web site (www.thelancet.com) and in the August edition of Lancet Neurology (2007; 6:734-746) that describes suggested revisions to the criteria for the diagnosis of Alzheimer's disease, including the use of cerebrospinal fluid (CSF) biomarkers.

The Position Paper presents the consensus recommendations of an international working group of Alzheimer's disease experts. The existing criteria for the diagnosis of AD were published in 1984 by the National Institute of Neurological Disorders and Stroke-Alzheimer's Disease and Related Disorders (NINCDS-ADRDA). The Position Paper suggests the existing criteria are out of date due to unprecedented growth of scientific knowledge in the field.

In the 1984 guidelines, CSF examination was recommended as an exclusion procedure for non-AD dementia. The Position Paper notes, "Since then, there has been a lot of research into the usefulness of AD-specific biomarkers that are reflective of the central pathogenic process of amyloid beta aggregation and hyperphosphorylation of tau protein." The Position paper goes on to state, "Cerebrospinal fluid biomarkers for detecting the key molecular pathological features of AD in vivo are available and can be assessed reliably." Specifically referencing the APNS p-tau 231 test, it later states, "Measurement of the concentration of p-tau, notably p-tau 231, increases the specificity for AD, especially in contrast to fronto-temporal lobar degeneration." In addition to the recognized diagnostic capability of CSF biomarkers, the Position Paper also discusses the high diagnostic usefulness of CSF biomarkers to identify individuals in the mild cognitive impairment (MCI) stage.

Commenting on the release of the Position Paper, Dr. Mony de Leon, Professor of Psychiatry and Director Center for Brain Health at NYU School of Medicine added, "Several high visibility, peer reviewed publications have also recently proposed that the diagnosis of AD could be improved with the addition of CSF biomarkers. In all these reports it has been concluded that markers for abnormalities in tau and amyloid beta are useful and should be considered for more widespread testing and evaluation. The pathological diagnosis of AD requires evidence for both tau and amyloid beta abnormality, however, relative to diagnostics, based on the experience of myself and my colleagues at NYU, the APNS p-tau 231 marker for hyperphosphorylated tau is individually the superior diagnostic tool. Shown to provide diagnostic specificity for AD, in our studies, we have observed that the diagnosis of AD and the early sensitivity for predicting AD at the MCI stage are significantly enhanced using p-tau 231."

Applied NeuroSolutions has 15 peer-reviewed publications that report the performance of our p-tau 231 CSF-based test, with an average overall sensitivity and specificity in the range of 85% to 95%, in various patient populations, including AD, depression, other neurological disorders and normal controls. The November issue of Brain (2006;129:3035-3041), reported that CSF p-tau 231 has a positive correlation with the current accepted "gold standard", autopsy confirmed AD brain tissue.

About Applied NeuroSolutions:

Applied NeuroSolutions, Inc. (OTC BB:APNS ) is developing, in collaboration with Eli Lilly and Company, novel therapeutic compounds to treat and diagnostics to detect Alzheimer's disease (AD) based on discoveries originating from the Albert Einstein College of Medicine. Applied NeuroSolutions has discovered biomarkers that the company believes will aid in the development of effective AD treatments. Applied NeuroSolutions has also been working on both a cerebrospinal fluid (CSF) diagnostic test and blood tests to detect AD at a very early stage. The CSF test can already differentiate AD patients from those with other diseases that have similar symptoms. There is currently no FDA approved diagnostic test to detect Alzheimer's disease. Alzheimer's disease currently afflicts over five million Americans, and the world market for AD therapy is currently estimated to be 30 million patients. For more information, visit www.appliedneurosolutions.com.

This press release contains forward-looking statements about Applied NeuroSolutions. The company wishes to caution the readers of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, the risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, potential competitive offerings, and access to capital. For further information, please visit the company's website at www.appliedneurosolutions.com, and review the company's filings with the Securities and Exchange Commission.


Source: Applied NeuroSolutions

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