C2N Earns CE Mark for Alzheimer’s Blood Test
C2N Diagnostics has been granted CE mark certification for PrecivityAD, a mass spectrometry-based blood test for Alzheimer’s disease.
The diagnostic is now cleared in Europe for evaluating patients being assessed for Alzheimer’s disease who show mild cognitive impairment or very mild dementia. C2N said its researchers found the test is able to predict Alzheimer’s disease brain pathology in people aged 60 and up with cognitive impairment.
“In Europe, our immediate use of the test is as a validated biomarker for use in late-stage clinical drug studies. The use of this biomarker to aid in screening individuals for participation in these studies has the potential to markedly reduce trial costs and speed enrollment,” the company said.