Amorfix Life Sciences Ltd. of Toronto has announced plans
to develop a diagnostic assay for Alzheimer’s disease in collaboration with QPS Holdings LLC, a contract research organization specializing in developmental services for device, biotech, and drug companies. Amorfix will work with QPS to analyze cerebral spinal fluid from Alzheimer’s patients in various stages of the disease and then perform studies to validate Amorfix’s proprietary EP-AD assay.
Amorfix’s goal is to sell the assay as a biomarker for use in clinical development and as an FDA-approved diagnostic to detect early-stage Alzeheimer’s disease. Company studies demonstrate that the assay can identify mild cognitive impairment in early-stage patients at a 94% sensitivity rate, according to Robert Gundel, president and CEO. He says that’s a higher sensitivity rate than that offered by other biomarkers used as comparisons in the study. According to Gundel, there are more than 93 new treatments for Alzheimer’s disease in ongoing clinical studies, making it “one of the most active areas of therapeutic development.”
The collaboration with Delaware-based QPS will speed market introduction of the EP-AD assay, Gundel says. Amorfix will continue to provide the assay for research use on a fee-for-service basis to pharmaceutical and biopharmaceutical companies.