FDA clears blood tests for early Alzheimer’s detection
FDA clears innovative blood test for earlier Alzheimer’s diagnosis (News-Medical.Net)
Summary: The FDA has cleared for marketing PrecivityAD2, a blood test developed by C2N Diagnostics using technology invented at Washington University School of Medicine, for the early diagnosis of Alzheimer’s disease. Unlike other FDA-cleared blood tests that use immunoassay methods, PrecivityAD2 uses high-resolution mass spectrometry to measure amyloid and tau biomarkers. The test has demonstrated more than 90% accuracy in diagnosing amyloid pathology, comparable to spinal taps and brain scans, even in patients with mild cognitive symptoms. FDA clearance allows broader marketing to clinicians and health systems and can facilitate insurance coverage, making the test more affordable and accessible.
Why it matters: FDA clearance allows PrecivityAD2 to be marketed more broadly to clinicians and health systems that rely upon FDA for quality assurance, and can facilitate insurance coverage, which makes the test more affordable and accessible.
"Previous studies demonstrated that the PrecivityAD2 test can diagnose the amyloid pathology of Alzheimer’s disease with more than 90% accuracy. It performs comparably to more invasive screening methods such as spinal taps and brain scans, even in patients with mild cognitive symptoms." — NEWS-MEDICAL.NET
Date: August 21, 2026 10:34 PM ET
URL: https://news-medical.net/news/20260821/FDA-clears-innovative-blood-test-for-earlier-Alzheimers-diagnosis.aspx
Generated Analysis Tone: Negative (50%)
Source Registry Score: 10.0/10 — High
Generated text and tone describe the analysis; the source registry score is not a factual truth rating.FDA clears blood test to aid evaluation for Alzheimer’s disease | WashU Medicine (Medicine.Washu.Edu)
Summary: The FDA has cleared for marketing PrecivityAD2, a blood test for Alzheimer’s disease based on technology developed at Washington University School of Medicine and commercialized by C2N Diagnostics. The test uses high-resolution mass spectrometry to measure amyloid and tau biomarkers, and prior studies show it diagnoses amyloid pathology with more than 90% accuracy. FDA clearance allows broader marketing to clinicians and health systems and can facilitate insurance coverage, making the test more affordable and accessible.
Why it matters: FDA clearance allows PrecivityAD2 to be marketed more broadly to clinicians and health systems that rely upon FDA for quality assurance, and can facilitate insurance coverage, which makes the test more affordable and accessible.
Date: August 21, 2026 02:50 PM ET
URL: https://medicine.washu.edu/news/fda-clears-blood-test-to-aid-evaluation-for-alzheimers-disease
Generated Analysis Tone: Negative (50%)
Source Registry Score: 10.0/10 — High
Generated text and tone describe the analysis; the source registry score is not a factual truth rating.Post ID: 65790329