Aggregated Abeta Is an Indicator of Alzheimer's Disease

The amyloid results from aggregation of misfolded Abeta protein. The new test is designed to specifically detect the aggregated protein in femtogram quantities (ten parts per trillion) from an AD patient's brain when it is spiked into plasma or cerebral spinal fluid (CSF).

Amorfix Life Sciences Ltd. (Mississauga, ON, Canada) has already obtained blood and CSF samples from AD patients and normal controls to begin testing assay verification. The company believes that detection of aggregated Abeta in blood or CSF would represent a significant advance in the search for a reliable indicator to show evidence of AD. It is expected that CSF will have a higher concentration of Abeta aggregates because they originate from the brain and are not diluted in the plasma.

At present the only way to diagnose AD prior to death is by brain biopsy, which is not performed because it is unethical. Amorfix hypothesizes that aggregated Abeta passes from the brain to the CSF and makes its way into the blood system. The presence of, or amount of aggregated Abeta in blood or CSF of Alzheimer's patients is not yet known.

Our AD diagnostic assay is now the most sensitive test available for Abeta protein based on our survey of existing tests. We have achieved the sensitivity required to test human Alzheimer's blood and CSF for aggregated Abeta, a hallmark of Alzheimer's disease, said Dr. Neil Cashman, CSO of Amorfix. In addition, we believe we can further improve the assay sensitivity by incorporating technology similar to that developed for our epitope protection (EP)-vCJD blood screening assay.

Amorfix is a theranostics company developing diagnostic devices and therapeutic products for targeting brain-wasting diseases. The company's EP technology enables it to specifically identify very low levels of aggregated misfolded proteins (AMP) in a sample of normal protein. Aggregated misfolded proteins are a common element of many brain wasting diseases and the ability to identify AMPs and understand their structure and mechanism of folding are the first steps to developing new treatments for these devastating diseases. Amorfix's lead programs are a diagnostic blood screening test for Variant Creutzfeldt-Jakob disease (vCJD) and a therapy for Amyotrophic Lateral Sclerosis (ALS).


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