ARUP Laboratories has introduced a blood test for phosphorylated tau 217 (pTau 217) to aid in diagnosing the pathology of Alzheimer's disease in individuals aged 60 years and above experiencing cognitive decline symptoms.
This minimally invasive test could lead to earlier identification of Alzheimer's by detecting related pathology through a blood sample.
The pTau 217 test was validated by the company using samples from Eli Lilly's Phase III TRAILBLAZER-ALZ 2 study, which included blood specimens and amyloid positron emission tomography (amyloid-PET) imaging outcomes from 524 subjects.
This biomarker is indicative of Alzheimer's pathology and could be identified in plasma, offering a less invasive alternative to traditional diagnostic methods, stated the company.
According to ARUP, traditional diagnostic methods for cognitive impairment, such as cerebrospinal fluid (CSF) biomarker assessment or amyloid-PET, are not easily accessible to many individuals. Plasma biomarkers present an accessible option to detect Alzheimer's pathology.
The test will be conducted using Quanterix’s SP-X platform and the Simoa assay kit, which employs pTau 217 antibody technology licensed from Lilly.
ARUP is committed to furthering research on biomarkers for neurodegenerative conditions. Its neuropathology sub-speciality director Qinwen Mao is currently investigating TAR DNA-binding protein of 43 kDa (TDP-43).
Last year, the company expanded its test offerings by including a CSF test for identifying the disease's biomarkers, and the new pTau 217 plasma is said to further enhance the company’s diagnostic services for Alzheimer's.
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 Alzheimer's 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.”
In February, ARUP and Tasso announced a partnership to develop at-home blood testing services to support clinical research.
