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C2N Receives CE Mark for PrecivityAD Alzheimer's Test

NEW YORK – C2N Diagnostics said on Tuesday that its PrecivityAD blood test for Alzheimer's has received the CE Mark from the EU as well as approval from the state of California to test patients out of its CLIA facility.

With the CE Mark, C2N can offer the test in Europe as an in vitro diagnostic to aid in the evaluation of patients with mild cognitive impairment or very mild dementia who are undergoing assessment for Alzheimer's disease.

The California approval means the company can now offer the test in 46 states, the District of Columbia, and Puerto Rico. C2N launched US sales of the test in October. It uses mass spectrometry to measures levels of amyloid beta (Aβ) and apolipoprotein E in patient blood to help doctors assess the likelihood that a patient has Alzheimer's.

"In Europe, our immediate use of the test is as a validated biomarker for use in late-stage clinical drug studies," C2N CEO Joel Braunstein said in a statement. "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. In the near future, we will take the next step and introduce the test into EU clinics for use as a diagnostic tool, as is already occurring in the US, with California becoming the latest addition."