Quanterix has introduced the new biomarker blood test, LucentAD, to facilitate the diagnosis of Alzheimer’s disease (AD) in patients.
The test has been designed to help assess patients experiencing cognitive symptoms consistent with the early signs of AD.
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Healthcare providers can use this test along with other diagnostic tools to rapidly evaluate the likelihood of a patient having amyloid pathology consistent with the disease.
Designed to be run by the company’s clinical laboratory improvement amendments (CLIA), the test measures phosphorylated tau protein isoform in plasma.
The isoform is phosphorylated at the 181 residue of the protein (p-Tau 181), a low-abundance protein in blood that needs high analytical sensitivity for its reliable measurement.
Its concentration in plasma and cerebrospinal fluid has been positively correlated to amyloid pathology present in the brain.
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By GlobalDataLucentAD leverages the Simoa p-Tau 181 assay, which was assessed in large longitudinal and cross-sectional cohorts.
Quanterix CEO Masoud Toloue said: “A year ago, Quanterix announced the validation of our laboratory-developed test to quantitatively measure p-Tau 181 in plasma as an aid in diagnostic evaluation of AD.
“The launch of Lucent Diagnostics and availability of the LucentAD test expands access to our p-Tau 181 test for healthcare providers and marks an important step in our goal to help build a global AD testing infrastructure.”
The introduction of the LucentAD test coincides with the FDA approval of Eisai’s Leqembi for AD.
In the Leqembi labelling for accelerated approval, various biomarkers including plasma p-Tau 181, which was measured using Quanterix’s Simoa platform, were employed to track response to therapy.
