Labcorp Launches FDA-Cleared Blood Test for Alzheimer’s

Labcorp (Burlington, NC) has announced the launch of Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio (Fujirebio Diagnostics, Malvern, PA), which is the first Food and Drug Administration (FDA)–cleared blood-based test that can be used to aid in the diagnostic evaluation ofAlzheimer disease (AD). According to a statement released by Labcorp, this test provides clinicians with a method to support early diagnosis of AD using a blood draw, a less invasive, more affordable, and more accessible method compared with other diagnostic approaches such as cerebrospinal fluid (CSF) and PET testing. The device is intended to be used for adults aged ≥50 years who present with signs of cognitive decline in the specialized care setting. Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio is not a standalone diagnostic or screening test, and results are intended to be interpreted alongside other clinical and diagnostic information.

Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio measures the ratio of phosphorylated tau 217 (p-tau217) to beta amyloid 1-42 (amyloid-β 1-42) in the blood—biomarkers associated with amyloid plaque deposition in the brain. The results are intended to help clinicians assess the likelihood of underlying AD pathology. According to Labcorp, Fujirebio has announced that Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio testing yielded a negative predictive value of 97% and a positive predictive value of 93% when evaluated in clinical studies.

In July, Quest Diagnostics (Secaucus, NJ) also announced plans to begin offering Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio. The diagnostic test received FDA 510(k) clearance in May of 2025.