ARUP Laboratories Introduces Innovative Blood Test for Alzheimer's Detection

ARUP Laboratories Unveils pTau 217 Blood Test for Alzheimer's Detection

In a significant advancement for Alzheimer’s disease (AD) diagnosis, ARUP Laboratories has launched a new blood test that measures phosphorylated tau 217 (pTau 217) levels in patients aged 60 and older. This innovative test aims to assist healthcare providers in distinguishing whether symptoms of cognitive decline are linked to AD pathology, facilitating earlier diagnosis and intervention for patients.

The pTau 217 test promises to be a game-changer in the field of neurodegenerative disease diagnostics. Traditionally, determining whether a patient’s cognitive impairment stems from AD has involved cumbersome and invasive procedures such as analyzing cerebrospinal fluid (CSF) or conducting amyloid positron emission tomography (amyloid-PET) scans. In contrast, the arterial blood test offers a minimally invasive alternative that can be performed more easily and is likely to be accessible to a larger patient population.

Dr. Heather Nelson, ARUP's medical director of Clinical Chemistry, highlighted the critical need for prompt diagnosis with the advent of disease-modifying therapies, stating, "This test offers a less invasive and more accessible way to provide evidence of AD pathology than alternative testing methods. Diagnostic delays could have dire consequences for patients’ outcomes."

The Alzheimer's Association asserts that AD accounts for 60-80% of dementia cases, and the pathological brain changes associated with the disease can begin two decades or more before clinical symptoms appear. These changes typically include the buildup of amyloid plaques and tau protein tangles in the brain, which can now be detected with greater ease through this blood test.

To validate the effectiveness of the pTau 217 test, ARUP relied on meticulously analyzed samples from Eli Lilly and Company's Phase 3 TRAILBLAZER-ALZ 2 clinical trial. The validation study incorporated blood samples alongside results from amyloid-PET imaging of 524 subjects, attesting to the reliability and accuracy of the new diagnostic approach. ARUP’s Sonia La`ulu voiced confidence in the test's quality, noting, "The comparison to PET imaging data significantly enhanced our trust in the findings."

While conventional methods for testing cognitive impairment have often deterred patients due to their invasive nature, the breakthrough reflects a shift towards more patient-friendly procedures. Notably, studies have shown that pTau 217 serves as a robust biomarker of AD pathology, often outperforming other available biomarkers. Its correlation with amyloid-PET results and CSF biomarkers furthers its credibility as a frontline diagnostic tool.

The implementation of this test involves state-of-the-art technology provided by Quanterix’s SP-X® platform, utilizing the Quanterix Simoa® assay kit, which incorporates pTau 217 antibody technology licensed from Eli Lilly. This strategic selection ensures that the test will leverage cutting-edge diagnostics, offering precise assessments for patients.

In addition to launching the pTau 217 test, ARUP is continuously researching emerging biomarkers linked to neurodegenerative diseases. One of the ongoing research initiatives includes the evaluation of TAR DNA-binding protein of 43 kDa (TDP-43), further solidifying ARUP's commitment to advancing diagnostic fronts in this critical medical area. Moreover, ARUP had also introduced a CSF test for detecting AD biomarkers in its testing menu the previous year, marking a significant expansion of its offerings to support enhanced diagnosis and management of Alzheimer's.

ARUP Laboratories, established in 1984 and affiliated with the University of Utah Spencer Fox Eccles School of Medicine, is a prominent reference laboratory and a non-profit organization. It boasts an extensive array of over 3,000 tests, including routine screenings and specialized molecular assays, positioning itself as a pioneer in laboratory research and diagnostic development.

For more information on the pTau 217 blood test and other diagnostic services, visit www.aruplab.com.