First blood test to help diagnose Alzheimer’s hits market

A U.S. firm has announced the first diagnostic blood test designed to help detect Alzheimer’s disease, although it has not been approved by the Food and Drug Administration (FDA) and the company has not yet published accuracy data.

The test, produced by C2N Diagnostics, measures amyloid particles as well as forms of a protein indicating increased genetic risk for the disease, The Associated Press reported on Monday. It combines them in a formula with other data such as individual patients’ age to determine their risk of amyloid buildup in the brain.

The diagnostic test is intended for people 60 or older who have detected cognitive problems, and is currently only available if ordered by a doctor. The test was recently cleared for sale in Europe and is available in most U.S. states.

“There are a thousand things that can cause someone to be cognitively impaired,” ranging from medications to dietary issues, C2N Diagnostics founder David Holtzman told the AP.

Company CEO Joel Braunstein said it intends to seek FDA approval and defended the product as a useful way to help diagnose the most common form of dementia.

“Should we be holding that technology back when it could have a big impact on patient care?” he asked, according to the AP.

Eliezer Masliah, neuroscience chief at the U.S. National Institute on Aging, said he would “be cautious about interpreting” the results of the test, adding “We’re encouraged, we’re interested, we’re funding this work but we want to see results.”

Heather Snyder of the Alzheimer’s Association similarly said the group will not endorse the test until it both receives FDA clearance and is studied in larger populations, telling the AP, “It’s not quite clear how accurate or generalizable the results are.”

Tags Alzheimer's disease C2N Diagnostics Dementia The Associated Press
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