EMA Agrees to Autism Biomarkers

January 21, 2016
Applied Clinical Trials

The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism.

European Autism Interventions – A Multicenter Study for Developing New Medications (EU-AIMS) – the largest multi-center study of potential autism medicines – announced it has forged an agreement with the European Medicines Agency on procedures for selecting study participants and assessing the effectives of new treatments.

The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism with the goal of providing researchers with the ability to identify which subtypes best respond to different treatments.

The regulatory agency also agreed on the importance of further study of LEAP’s proposed biomarkers for autism. These include the results of brain-imaging tests that can track brain activity and connectivity, eye-tracking studies that measure attention to social cues and analysis of biological samples such as blood, saliva and urine. Biological samples are particularly important for identifying genetic risk factors that may contribute to some forms of autism.

Read the full release from Autism Speaks.