The FDA has cleared the PrecivityAD2 blood test from C2N Diagnostics to identify Alzheimer’s disease markers.

The U.S. Food and Drug Administration has cleared the PrecivityAD2 blood test, developed by C2N Diagnostics, for marketing to help identify amyloid plaques in the brain associated with Alzheimer’s disease. This innovative test uses high-resolution mass spectrometry to provide quantitative measurements of biomarkers, offering a less invasive alternative to traditional methods like spinal taps and brain scans. Developed by a team at Washington University School of Medicine, the test provides accurate results with over 90% accuracy in diagnosing amyloid pathology. Randall J. Bateman and David M. Holtzman, who co-founded C2N Diagnostics, noted that the clearance allows the test to reach more patients, enabling earlier treatment when it is most effective. The test measures the ratio of amyloid levels and two forms of tau protein in the blood. This advancement provides clinicians with a reliable tool for early diagnosis, potentially making the test more affordable and accessible through broader insurance coverage.

Sources

• The Washington Post
  FDA approves a new blood test to detect signs of Alzheimer’s
• CNN
  Another Alzheimer’s blood test gets OK from FDA
• WTHR
  FDA approves new Alzheimer’s blood test from Roche, Eli Lilly
• WSJ
  FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly
• WashU Medicine
  FDA clears blood test to aid evaluation for Alzheimer’s disease