Lumipulse® pTau-217/Beta Amyloid 42 Ratio
The first FDA-cleared blood test for patients being assessed for Alzheimer’s disease
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Improves access to amyloid testing with a simple blood draw and automated immunoassay
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Combines pTau-217 and Beta Amyloid 42 for greater accuracy in identifying amyloid positron emission tomography (PET) positivity than plasma pTau-217 alone
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Lowers costs compared to PET scan and is less invasive than cerebral spinal fluid (CSF) testing, with results comparable to both methods
A growing need for better dementia care
By 2030, 1 in 6 people globally will be 60 years or older . As global life expectancies continue to increase, so do cases of dementia. While the recent availability of anti-amyloid therapies has changed patient management strategies, advancements in high-sensitivity immunoassay platforms have paved the way for a new era in the evaluation of Alzheimer’s disease. Because of these breakthroughs, blood-based biomarkers can now be effective tools in the assessments of individuals with symptoms of cognitive impairment.
Clearer answers for your complex questions
In the context of all clinical findings in individuals presenting with cognitive impairment, the Lumipulse® pTau-217/Beta Amyloid 42 Ratio has been approved by the FDA to aid in the identification of amyloid-related pathology, which is associated with Alzheimer’s disease. This test is not intended as a screening test for Alzheimer’s disease in asymptomatic individuals.
About the Lumipulse® pTau-217/Beta Amyloid 42 Ratio
Intended use1
To aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer’s disease
Indicated for adult patients, aged 50 years and older, presenting at a specialized care setting with signs and symptoms of cognitive decline
Results must be interpreted in conjunction with other patient clinical information
This test is not intended as a screening or stand-alone diagnostic test
Clinical test performance
The Lumipulse® pTau-217/Beta Amyloid 42 Ratio results are highly concordant with amyloid PET imaging and amyloid CSF ratio results.
92%
of individuals with a positive result have a positive CSF or amyloid PET scan result
97%
of individuals with a negative result have a negative CSF or amyloid PET scan result
Result Interpretation
In patients aged ≥50 years presenting at a specialized care setting with signs and symptoms of cognitive decline, results should be interpreted as follows:
RESULT | RATIO INTERPRETATION* | PREDICTIVE VALUE (95% CI) | |
≥0.00738 | POSITIVE | Consistent with patients LIKELY to have amyloid pathology. Result does not establish a diagnosis of AD or other cognitive disorders. | PPV 91.8% |
0.00371-0.00737 | INTERMEDIATE** | Consistent with patients UNCERTAIN to have amyloid pathology. Consider further testing. |
|
≤0.00370 | NEGATIVE | Consistent with patients UNLIKELY to have amyloid pathology. Should investigate for other causes of cognitive decline. | NPV 97.3% (93.9%-98.8%) |
*Test results must be interpreted in conjunction with other patient clinical information. This test is not intended as a screening or stand-alone diangostic assessment.
**19.6% of patients had an indeterminate result in the clinical study that supported the FDA clearance.
PPV, positive predictive value; NPV, negative predictive value
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Reference
- Lumipulse G pTau-217/β-Amyloid 1-42 Plasma Ratio: Package Insert; Instructions for use