We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App

Groundbreaking pTau217 Blood Test as Accurate as Brain Imaging or CSF Testing in Diagnosing Alzheimer's

By LabMedica International staff writers
Posted on 21 Mar 2024
Print article
Image: The novel blood-based biomarker assay offers a simple, accessible, timely, and cost-effective approach to Alzheimer`s diagnosis (Photo courtesy of Shuttestock)
Image: The novel blood-based biomarker assay offers a simple, accessible, timely, and cost-effective approach to Alzheimer`s diagnosis (Photo courtesy of Shuttestock)

Alzheimer’s disease (AD) is a neurodegenerative condition that causes the brain to deteriorate over time, marked by the buildup of certain harmful proteins that eventually lead to a decline in brain function and cell death. These changes can happen long before any symptoms show up. Scientists have found certain proteins in the cerebrospinal fluid that are good indicators of AD. One of the most promising markers for early and more precise detection of AD in the blood is phosphorylated tau at position 217 (pTau217). It's seen as a game-changer for diagnosing AD sooner, categorizing patients for research studies, and improving how patients are cared for and treated. Now, an innovative and novel blood test can be used in the screening, diagnosis, and monitoring of AD based on the circulating level of this promising biomarker pTau217.

ALZpath Dx (Carlsbad, CA, USA) has developed a robust and scalable plasma-based ultra-sensitive assay, branded ALZpathDx, utilizing a proprietary monoclonal pTau217 antibody and peptide calibrator. This blood-based ELISA assay has been developed on the semi-automated single-molecule array (Simoa) platform. ALZpathDx measures pTau217 in blood, which can signal amyloid and tau accumulation in the brain years prior to the onset of cognitive symptoms. ALZpathDx also correlates strongly with prior diagnostic methods, including positron emission tomography (PET) imaging, the current gold standard diagnostic technique. 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.

An international peer-reviewed study evaluating the performance of its ALZpath Dx assay in a 786-patient study found 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 PET imaging. The 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.

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Magnetic Bead Separation Modules
Complement 3 (C3) Test
GPP-100 C3 Kit
Gold Member
Real-time PCR System
GentierX3 Series

Print article


Clinical Chemistry

view channel
Image: The 3D printed miniature ionizer is a key component of a mass spectrometer (Photo courtesy of MIT)

3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models

Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more


view channel
Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)

Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more


view channel
Image: The groundbreaking treatment approach has shown promise in hard-to-treat cancers (Photo courtesy of 123RF)

Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment

Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means... Read more


view channel
Image: Microscope image showing human colorectal cancer tumor with Fusobacterium nucleatum stained in a red-purple color (Photo courtesy of Fred Hutch Cancer Center)

Mouth Bacteria Test Could Predict Colon Cancer Progression

Colon cancer, a relatively common but challenging disease to diagnose, requires confirmation through a colonoscopy or surgery. Recently, there has been a worrying increase in colon cancer rates among younger... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.