Cognitive Decline Can Start 20 Years Before Symptoms Appear. The FDA Just Cleared a Blood Test for Adults as Young as 40
The PrecivityAD2 test can screen adults decades before Alzheimer’s is typically diagnosed.
The tools for catching Alzheimer’s early on just got even sharper.
On Thursday, the U.S. Food and Drug Administration cleared C2N Diagnostics’ PrecivityAD2 blood test for use in adults as young as 40 who show signs of cognitive impairment. This is the first FDA-cleared Alzheimer’s blood test available to patients at that age.
According to the Alzheimer’s Drug Discovery Foundation, pathology of the disease can begin 15 to 20 years before symptoms surface. Closing that gap between early disease and early detection has been a long-standing goal for researchers. A test that reaches people in their 40s and 50s pushes detection closer to the point where intervention can do the most good.
For younger adults, that earlier window is especially hard to reach. Early-onset Alzheimer’s “can be harder to recognize because symptoms may initially be attributed to stress, depression, or other causes,” Laura Nisenbaum, PhD, the ADDF’s interim chief science officer, told Inc.
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The clearance builds on almost 20 years of investment by the ADDF, which first backed C2N with seed funding in 2008 and later added a $7 million-aid-package-for-fire/” title=”€20 million aid package for fire”>million investment through its Diagnostics Accelerator.
“Just over a year ago, there were no FDA-cleared blood tests for Alzheimer’s and now we have three,” Isobel Coleman, the ADDF’s CEO, said in a release.
She framed the news as proof that early, sustained funding of translational science can move ideas “from the lab to patients.”
Source: www.inc.com
