Plasma Biomarker Test to Aid in Alzheimer’s Diagnosis Cleared by FDA

The Food and Drug Administration (FDA) has announced the 410(k) clearance of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (Fujirebio Diagnostics, Malvern, PA) to aid in the diagnostic evaluation of Alzheimer disease (AD), marking it the first in vitro diagnostic test for this disease state to receive such authorization. The assay measures the ratio of phosphorylated tau 217 (p-tau217) to beta-amyloid 1-42 in plasma and is intended for adults aged 55 years and older under clinical evaluation for cognitive decline. The test is not for standalone use but is cleared as an adjunct to other diagnostic tools, such as positron emission technology (PET) or assessments based on cerebrospinal fluid.

The FDA’s decision was supported by data from a multicenter clinical study that included plasma samples from 499 adult participants with cognitive impairment. Investigators compared results from the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio to results from amyloid PET or CSF biomarker testing.

Key results from this clinical trial include the following: 

• 91.7% of individuals with a positive plasma test had amyloid pathology confirmed via PET or CSF biomarker testing.
• 97.3% of individuals with a negative plasma test had no evidence of amyloid pathology confirmed via PET or CSF biomarker testing.
• <20% of participants received indeterminate results from the plasma test.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said Martin A. Makary, MD, MPH, commissioner of the FDA. “Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”