Neurocode Launches Groundbreaking pTau217 Blood Test for Alzheimer's Disease Clinical Diagnosis

BELLINGHAM, Wash., March 4, 2024 /PRNewswire/ -- Neurocode USA, Inc, a specialized clinical laboratory that offers world-class testing solutions for neurological disorders, is pleased to announce the clinical launch of ALZpath Dx, an innovative and novel blood test that can be used in the screening, diagnosis, and monitoring of Alzheimer's disease (AD) based on circulating level of pTau217 in the blood. Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.

Neurocode's pioneering assay measures levels of phosphorylated tau at position 217 (pTau217). pTau217 is widely considered to be the leading transformative blood-based biomarker that will enable earlier and more accurate AD diagnosis, better stratification of patients for clinical trials, improved patient care and treatment, and greater diagnostic specificity and sensitivity than other blood-based biomarkers. The test is powered by the Simoa ® (single-molecule assay) technology of Quanterix Corp. 

"The clinical availability of the ALZpath Dx test is significant as it provides a more scalable, more accessible, and less invasive option for the diagnosis of patients in earlier stages of the disease, when recently-approved disease-modifying therapies are most beneficial. Patients and their families gain unprecedented ease of access to early and accurate diagnosis and the opportunity for timely treatment," said Ryan Fortna, MD PhD, Medical Director of Neurocode. "Additionally, this blood-based test is as accurate as brain imaging or CSF testing, but is faster, more accessible, less expensive, and less invasive, and it does not require radiation exposure."

Recently, ALZpath announced results of an international peer-reviewed study published in JAMA Neurology, evaluating the performance of its ALZpath Dx assay in a 786-patient study. The findings demonstrated that the ultra-sensitive immunoassay showed high diagnostic accuracy in identifying elevated amyloid in the brain across all cohorts. The accuracy was significantly higher than other blood-based biomarker combinations and equivalent to cerebrospinal fluid (spinal tap) biomarkers. It demonstrated high accuracy in predicting AD brain pathologies (amyloid-beta plaques and tau tangles) as identified by positron emission tomography (PET) imaging, the current gold standard diagnostic technique.

Neurocode is the first laboratory in the world to offer the ALZpath Dx test for clinical use within a CAP-accredited, CLIA-certified facility. Their validation study used over 1,700 samples with amyloid PET imaging and 150 subjects with post-mortem (autopsy) pathology, demonstrating an area under the curve (AUC) of 0.94, significantly exceeding the 90% accuracy threshold for a standalone diagnostic AD test proposed by the Alzheimer's Association Workgroup in their 2023 draft proposal for the Revised Criteria for Diagnosis and Staging of Alzheimer's Disease.

Andreas Jeromin, PhD, Chief Scientific Officer of ALZpath, said, "The availability of ALZpath Dx in our first partner laboratory marks a significant milestone in making this test available for clinical use, and we are thrilled to collaborate with Neurocode. Looking ahead, ALZpath is planning to expand our network to help patients, their families, health care providers and pharmaceutical/biotech companies, and to improve care and management of a disease that devastates so many lives."

The test must be ordered by a healthcare provider. Sample collection kits are provided to facilitate blood collection and shipping to Neurocode by an affiliated phlebotomy site. Information about ordering, sample collections and shipping requirements can be found on their 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. They 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 Dx test and Neurocode's full range of diagnostic solutions, please visit neurocode.com or contact us below.

About ALZpath
ALZpath is a leading provider of innovative diagnostic solutions for Alzheimer's disease and related dementias. The novel ALZpath Dx assay is transforming Alzheimer's disease diagnosis and treatment monitoring, providing more accurate and accessible tools for clinicals and researchers worldwide. To learn more about the company, please visit alzpath.bio.

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

ALZpath contact:
Andreas Jeromin, PhD
ALZpath Chief Scientific Officer
[email protected]

SOURCE Neurocode Labs