Neurocode USA's ALZpath Assay Marks a Breakthrough in Alzheimer's Diagnostics

A Groundbreaking Development in Alzheimer's Diagnostics

Neurocode USA Inc., a leading laboratory specialist in blood biomarkers for Alzheimer's Disease (AD), has announced the release of a significant study that compares the performance of two prominent assays for diagnosing this complex condition: the ALZpath assay and the Fujirebio assay. Published in Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, this research reveals critical insights into the effectiveness of blood tests for early-stage AD detection.

The focus of this research is phosphorylated tau at position 217 (pTau217), a biomarker that has emerged as a key player in identifying AD’s amyloid pathology. The study affirms that the ALZpath assay not only matches the diagnostic accuracy traditionally found in brain imaging and cerebrospinal fluid (CSF) testing but actually surpasses them, especially in the early phases of the disease where timely diagnosis can lead to better patient outcomes.

As Dr. Hans Frykman, Chief Scientific Officer at Neurocode, points out, early and accurate detection plays a crucial role in mitigating the progression of Alzheimer’s disease. He notes, “This study highlights the exceptional capabilities of Neurocode's ALZpath pTau217 assay and its transformative potential for Alzheimer’s diagnostics.” This assertion aligns with current industry demands for accessible and precise testing options that can aid healthcare providers in effectively managing patient care.

Neurocode proudly claims the title of the first laboratory in the United States to offer the ALZpath pTau217 assay as a laboratory-developed test (LDT) available for clinical use. This assay is powered by the Simoa® technology, a highly sensitive digital enzyme-linked immunosorbent assay (ELISA) that utilizes the Quanterix HD-X Analyzer™, specially designed for such intricate diagnostic tasks.

The research details the extensive clinical validation studies that support the assay's accuracy, which achieved an impressive area under the curve (AUC) score of 0.94. This result exceeds the National Institute on Aging and the Alzheimer’s Association (NIA-AA) standards, which require a minimum of 90% accuracy for AD diagnosis and staging. Such validation not only emphasizes the reliability of the ALZpath assay but also positions it as a crucial resource for clinicians navigating the challenges of AD diagnosis.

Healthcare providers interested in utilizing the ALZpath assay can seamlessly order sample collection kits from Neurocode, which facilitates the collection and shipping processes necessary for testing. Detailed information on how to order kits, along with sample collection and shipping requirements, is readily available on the company’s website.

Neurocode is more than just a clinical laboratory; it is a pioneer in innovating FDA-approved and laboratory-developed tests which focus on neurodegenerative diseases and neuroimmunology biomarkers. Collaborating closely with researchers, Neurocode strives to enhance the field of Alzheimer’s diagnostics while ensuring thorough validation of novel biomarkers that empower physicians to make informed decisions. To discover more about the ALZpath pTau217 assay and other diagnostic solutions offered by Neurocode, visit neurocode.com.

In an era where early detection of Alzheimer's is becoming increasingly critical, Neurocode's advancements could very well set a new standard in the realm of diagnostic tools and patient care. As the biotechnology field progresses, innovations like the ALZpath assay will undoubtedly reshape how healthcare professionals approach Alzheimer's disease and its management.