EMA consults on first qualification opinion on a clinical biomarker
This article was originally published in Scrip
The European Medicines Agency has for put out for public consultation its first "qualification opinion" on a biomarker for use in humans, and whether two cerebral spinal-fluid related biomarkers are qualified in selecting subjects for trials in early Alzheimer's disease.
The EMA's "qualification opinion" process is a voluntary, scientific pathway that may lead to an opinion from the agency's drug evaluation committee (the CHMP) on the acceptability of a specific use of the proposed method. The opinions are based on an assessment of data submitted to the agency and the public is consulted on all such qualification opinions.
In this current case, the EMA states that low levels of Aβ1-42 and high levels of total tau 1 in the cerebrospinal fluid of patients with mild cognitive impairment seem to be linked to a higher risk of developing Alzheimer's disease-related dementia. As both proteins are difficult to measure, laboratories will need to follow international guidelines and standardised quality control procedures when measuring them, the agency adds.
The draft opinion is the first for use in humans that the EMA has issued. In October 2010, the agency issued an opinion to predict kidney damage from rats.
Comments from stakeholders on the EMA's opinion will be accepted until 23 March.