First clinical biomarker qualification released for public consultation
The European Medicines Agency has released the first qualification opinion for a clinical biomarker for public consultation. The biomarker is intended to identify patients who can be recruited for clinical trials of treatments for pre-dementia Alzheimer's disease.
The draft opinion states that low levels of the protein Aβ1-42 and high levels of the protein T-tau 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. Because both proteins are difficult to measure, laboratories will need to follow international guidelines and standardised quality control procedures when measuring them.
The opinion is open for comments until 23 March 2011.
Biomarkers are tests that can be used to follow body processes and diseases in humans and animals. They can be used to predict how a patient will respond to a medicine or whether they have, or are likely to develop, a certain disease. On request, the Agency can give an opinion on the qualification of the use of a biomarker, to indicate its acceptability for a specific use in pharmaceutical research and development.
The Agency's Committee for Medicinal Products for Human Use (CHMP) issues biomarker qualification opinions, based on recommendations from its Scientific Advice Working Party (SAWP). The opinions are based on an assessment of data submitted to the Agency. The public is consulted on all such qualification opinions issued by the Agency.
This draft qualification opinion is the first for use in humans that the Agency has issued. In October 2010, the Agency issued an opinion on a biomarker to predict kidney damage in rats.