Neurocode Study Highlights Superior Performance of ALZpath pTau217 Assay in Alzheimer's Diagnosis

BELLINGHAM, Wash., Jan. 28, 2025 /PRNewswire/ -- Neurocode USA Inc, a leading clinical laboratory specializing in blood biomarkers for Alzheimer's disease (AD) diagnosis, is pleased to announce the publication of a groundbreaking 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. Neurocode is the only laboratory in the U.S. with the ALZpath pTau217 assay available as a laboratory developed test (LDT) for clinical use

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," said Dr Hans Frykman, 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. 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^™.

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. Sample collection kits are provided to facilitate collection and shipping to Neurocode. Information about ordering a kit, sample collections and shipping requirements, and more can be found on our website.

About Neurocode

Neurocode is a clinical laboratory that offers novel and innovative FDA-approved, and laboratory-developed tests, specializing in neurodegeneration and neuroimmunology biomarkers for clinical and research use. We work closely with researchers to advance the field of AD diagnostics and perform thorough validations of novel biomarkers to empower clinicians to make informed decisions. To learn more about accessing the ALZpath pTau217 and Neurocode's full range of diagnostic solutions, please visit neurocode.com or contact us below.

Neurocode contact:
Michael Metke
Medical Science Liaison
[email protected]
+1 425 312 3791

SOURCE Neurocode Labs