Amorfix achieves target sensitivity with its Alzheimer's disease diagnostic test

Amorfix Life Sciences has announced that its diagnostic test for the presence of aggregated Abeta in Alzheimer's disease is ready to be applied to patient samples.

The company has adapted its test to specifically detect aggregated Abeta protein (amyloid) in femtogram quantities (ten parts per trillion) from an Alzheimer's brain when it is spiked into plasma or cerebral spinal fluid (CSF).

"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, Chief Scientific Officer of Amorfix. "In addition, we believe we can further improve the assay sensitivity by incorporating technology similar to that developed for our EP-vCJD(TM) Blood Screening Assay."

The company obtained ethical approval to collect and use blood from Alzheimer's patients for assay validation, and has already obtained the necessary blood and CSF samples from Alzheimer's patients and normal controls to begin testing.

Alzheimer's disease is associated with an accumulation of protein aggregates, called amyloid, in the brain. Research has shown that amyloid results from aggregation of misfolded Abeta protein. The Amorfix AD diagnostic test has been developed to detect aggregated Abeta, the characteristic feature of Alzheimer's disease, in a blood sample or CSF whereas existing assays only detect Abeta. The company believes that detection of aggregated Abeta in blood or CSF would represent a significant advancement in the search for a reliable indicator to show evidence of Alzheimer's disease. The company believes that CSF will have a higher concentration of Abeta aggregates because they originate from the brain and are not diluted in the plasma. There are currently no reliable methods for diagnosing this disease prior to death. Amorfix hypothesizes that aggregated Abeta passes from the brain to the CSF and makes its way into the blood system through a known physiological pathway. As there is no test for aggregated Abeta, the presence of or amount of aggregated Abeta in blood or CSF of Alzheimer's patients is not known.

"The Amorfix team has made significant progress in the development of a test to diagnose Alzheimer's disease since our original investment. We continue to be supportive of their efforts to find a diagnostic solution to such a devastating disease," commented Dr. Christian Burks, President & CEO of Ontario Genomics Institute.