US-based non-profit reference laboratory ARUP Laboratories has launched a blood test for phosphorylated tau 217 (pTau 217) to identify Alzheimer’s disease (AD) pathology in patients aged 60 and above.
The minimally invasive test, which detects the pTau 217 biomarker in blood, offers a widely accessible diagnostic tool for the earlier detection of AD-related cognitive decline.
The pTau 217 test was validated using samples from Lilly’s Phase 3 TRAILBLAZER-ALZ clinical trial involving 524 individuals.
ARUP clinical chemistry medical director Heather Nelson said: “The advent of disease-modifying therapies has accelerated the need for early diagnosis since diagnostic delays for Alzheimer’s disease could adversely affect outcomes.
“This test offers a less invasive and more accessible way to provide evidence of AD pathology than alternate means.”
Traditional methods for AD pathology evaluation, such as cerebrospinal fluid (CSF) biomarker evaluation or amyloid positron emission tomography (PET), are invasive.
The new plasma biomarker test offers a less invasive alternative, making it more accessible for patients.
The test will be conducted on Quanterix’s SP-X platform using the Quanterix Simoa assay kit, featuring pTau 217 antibody technology licensed from Lilly.
The pTau 217 plasma test further expands its diagnostic capabilities.
Last year, ARUP added a test for AD biomarkers in CSF to its offerings, and the lab continues to explore emerging biomarkers for neurodegenerative diseases.
Its neuropathology subspecialty director Qinwen Mao is researching TAR DNA-binding protein of 43 kDa (TDP-43).
ARUP special chemistry, endocrinology, and mass spectrometry medical director Kelly Doyle said: “In many clinical studies, pTau 217 has been shown to be an effective biomarker of AD pathology, outperforming other biomarkers.
“Blood-based pTau 217 correlates well with amyloid-PET results and CSF biomarkers but with the benefit of being minimally invasive and broadly accessible.”
Earlier this year, US-based AI health tech company Pramana partnered with ARUP to digitise pathology slides and develop AI-powered algorithms.
The collaboration combines ARUP’s haematopathology expertise with Pramana’s SpectralHT whole-slide imaging scanners to improve diagnostic precision.
