The U.S. Food and Drug Administration clears the PrecivityAD2 blood test for early Alzheimer’s disease diagnosis.

The U.S. Food and Drug Administration has cleared the PrecivityAD2 blood test for marketing, providing a less invasive method for identifying amyloid plaques in the brain associated with Alzheimer’s disease. Developed by C2N Diagnostics, a startup from Washington University School of Medicine, the test uses high-resolution mass spectrometry to provide quantitative measurements of biomarkers. Randall J. Bateman, MD, and David M. Holtzman, MD, co-led the team that developed the foundational technology for the test. The innovation allows clinicians to evaluate patients for Alzheimer’s disease using a single blood draw, offering a comparable accuracy to more invasive methods like spinal taps and brain scans. This clearance is expected to facilitate broader marketing and potential insurance coverage, making the test more affordable and accessible. Early detection is critical because recent treatments capable of slowing the progression of the disease are most effective when started early. The PrecivityAD2 test has demonstrated more than 90% accuracy in diagnosing amyloid pathology in previous studies.

Sources

• WSJ
  FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly
• The Washington Post
  FDA approves a new blood test to detect signs of Alzheimer’s
• qz.com
  FDA clears Roche and Eli Lilly's Alzheimer's blood test for primary and specialty care
• WashU Medicine
  FDA clears blood test to aid evaluation for Alzheimer’s disease
• Reuters
  Roche, Eli Lilly's Alzheimer's blood test gets FDA clearance