Diadem Receives CE-IVD Mark for Its AlzoSure Predict Prognostic Blood Test

Diadem has received a CE IVD (in vitro diagnostic) mark for its AlzoSure Predict blood test for the early prediction of Alzheimer's disease.

The biomarker test can identify with high accuracy whether individuals over age 50 who have signs of cognitive impairment will or will not progress to Alzheimer's disease up to six years before definitive symptoms are apparent, according to the Italy-based company.

The CE mark certification was supported by positive clinical data from a 482-patient phase l study. Patients were age 50 or older at the start of the study and were asymptomatic or at early stages of Alzheimer’s disease or other dementias.

The FDA issued the diagnostic test a Breakthrough Device designation in January.