Description

An FDA-cleared blood test to aid in the evaluation of amyloid pathology associated with Alzheimer’s disease.

The Lumipulse® pTau-217/Beta Amyloid 42 Ratio is an advanced blood-based biomarker test designed to help determine whether amyloid pathology associated with Alzheimer’s disease is likely to be present.

Unlike tests that measure beta amyloid alone, Lumipulse evaluates the relationship between two important Alzheimer-related biomarkers:

  • Phosphorylated Tau 217 (pTau-217)
  • Beta Amyloid 1-42 (Aβ42)
  • pTau-217/Aβ42 Ratio

What Do the Results Mean?

The test provides a Negative, Indeterminate, or Positive interpretation based on the pTau-217/Aβ42 ratio.

Negative: Amyloid pathology is unlikely.

Indeterminate: The result does not clearly establish the likelihood of amyloid pathology, and additional evaluation may be appropriate.

Positive: Amyloid pathology is likely.

Who Is This Test For?

The FDA-cleared intended use is for adults age 50 and older who have signs or symptoms of cognitive decline and are being evaluated for possible Alzheimer’s disease in a specialized care setting.

Symptoms may include:

  • Progressive memory problems
  • Mild cognitive impairment
  • Changes in thinking or reasoning
  • Other unexplained cognitive decline

Why Is This Test Important?

Historically, determining whether amyloid pathology was present often required specialized brain imaging such as an amyloid PET scan or cerebrospinal fluid testing obtained through a lumbar puncture.

The Lumipulse blood test provides a less invasive way to help determine whether amyloid pathology is likely to be present and whether additional neurological evaluation or testing may be appropriate.

Important Information

Lumipulse is not intended as a stand-alone diagnosis of Alzheimer’s disease and is not intended for general screening of people without symptoms.

A positive result does not by itself establish a diagnosis of Alzheimer’s disease. Results should be interpreted together with symptoms, medical history, cognitive assessment, and other appropriate clinical evaluation.

Specimen: Plasma