Summary:
Neurocode USA Inc. published a study showing that its ALZpath pTau217 assay outperforms the Fujirebio assay in detecting Alzheimer’s disease, especially in early stages.

Takeaways:

  1. The ALZpath assay demonstrated superior diagnostic accuracy compared to Fujirebio’s test, particularly for early-stage Alzheimer’s detection.
  2. Neurocode is the first U.S. lab to offer the ALZpath pTau217 assay as a laboratory-developed test (LDT) for clinical use.
  3. The assay achieved an AUC of 0.94, surpassing the 90% accuracy threshold set by NIA-AA for AD diagnosis.

Neurocode USA Inc, a clinical laboratory specializing in blood biomarkers for Alzheimer’s disease (AD) diagnosis, has published a new study comparing the performance of two prominent pTau217 assays: the ALZpath assay and the Fujirebio assay.

Phosphorylated tau at position 217 (pTau217) is a biomarker for Alzheimer’s amyloid pathology and is widely expected to transform AD diagnosis through broadly accessible high-accuracy blood tests, according to the company. Neurocode is the only laboratory in the U.S. with the ALZpath pTau217 assay available as a laboratory developed test (LDT) for clinical use.

Neurocode Study Highlights Assays’ Performance

The study highlights the robust clinical performance of both assays in detecting AD. However, the findings reveal that the ALZpath assay offers superior diagnostic accuracy, particularly in the early stages of disease progression, where early detection is critical for effective intervention.

“Early and accurate diagnosis of Alzheimer’s is a cornerstone for improving patient outcomes,” says Hans Frykman, MD, CSO of Neurocode. “This study underscores the exceptional capabilities of Neurocode’s ALZpath pTau217 assay and its role in transforming Alzheimer’s diagnostics.”

The study, published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, is expected to have significant implications for the field of AD diagnostics and patient management, according to the company. Neurocode’s ALZpath assay is positioned as a key resource for healthcare providers navigating the complexities of early AD diagnosis. The assay is powered by Simoa®, an ultrasensitive digital ELISA technique utilizing the Quanterix HD-X Analyzer™.

First In the World

Neurocode is the first laboratory in the world to offer the ALZpath pTau217 for clinical use within a CAP-accredited and CLIA-certified facility. The large and comprehensive clinical validation studies performed by Neurocode underscore the accuracy and reliability of the assay. The demonstrated area under the curve (AUC) of 0.94 exceeds the 90% accuracy threshold required by the National Institute on Aging and the Alzheimer’s Association (NIA-AA) in their recently-revised criteria for AD diagnosis and staging.

The ALZpath pTau217 must be ordered by a healthcare provider.

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