Preliminary data from Amorfix human diagnostic test for Alzheimer's presented at ICAD

Amorfix Life Sciences, a product development company focused on diagnostics and therapeutics for misfolded protein diseases, presented a paper on Sunday July 17th, 2011 at the International Conference on Alzheimer's disease in Paris, France. The poster presentation, entitled "Development of An Ultra Sensitive Assay for Detection of Aggregated Beta Amyloid in Human CSF", is the first presentation of preliminary data generated using the Company's EP-AD Diagnostic CSF Test. This paper is the result of a collaboration with Dr. Kaj Blennow from the Sahlgrenska University Hospital in Sweden.

This preliminary proof-of-concept validation was performed with a total of thirty-five human CSF samples from Alzheimer's disease (AD) patients and control subjects. The identity of the samples was blinded to Amorfix and was only revealed following the completion of data analysis. The results obtained from the EP-AD Diagnostic CSF Test were as follows:  The assay correctly identified 12/17 AD and 14/18 Control CSF samples (74% sensitivity and 79% specificity, respectively). Experiments are now ongoing to improve both the sensitivity and specificity for better detection of aggregated Abeta present in AD CSF.

"We have developed a unique system for the detection and quantification of the aggregated Abeta peptide, a recognized biomarker for AD. This initial proof-of-concept validation suggests that this assay has promise as a potential diagnostic biomarker assay for AD. Further studies with a larger sample set are ongoing and will be required to validate the Amorfix EP-AD Diagnostic CSF Test and, in addition, to evaluate its potential for identifying individuals with mild cognitive impairment (MCI) at the early onset of symptoms" said Dr. Louise Scrocchi, Associate Director of Research and Development.

"We are very excited about our AD diagnostic program. Our human AD test follows in the footsteps of the A4 test, Amorfix's at-market preclinical assay. The initial results from the EP-AD Diagnostic CSF Test represent a significant advancement towards the development of a diagnostic tool that will not only aid in the accurate diagnosis of patients with AD but also may have the potential to identify patients with MCI who may be at risk to progress to AD" said Dr. Robert Gundel, Amorfix Chief Executive Officer.  "This is an area of scientific importance as the number of AD patients is expected to grow at a high rate over the next few decades as the population ages.  Our plan is to complete the optimization of the assay and identify a development partner to rapidly bring it to the market".

Source: AMORFIX LIFE SCIENCES LTD.