Quanterix Launches LucentAD Biomarker Blood Test to Aid Physician Diagnosis of Alzheimer’s Disease in Patients

Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery and breakthrough diagnostics through ultrasensitive biomarker detection, today announced it has launched LucentAD, a test to assist in the evaluation of patients experiencing cognitive symptoms consistent with the early signs of Alzheimer’s disease (AD). The LucentAD test, which will be available to healthcare providers as an aid in conjunction with other diagnostic tools, provides clinicians with a simplified process to quickly assess the likelihood of a patient having amyloid pathology consistent with AD. This information will help healthcare providers determine appropriate follow up and treatment planning for a suspected Alzheimer’s patient.

The LucentAD test is run by Quanterix’s CLIA laboratory, which powers many of the clinical trials associated with AD. Lucent Diagnostics is Quanterix’s new healthcare provider-facing portal, launched to meet the needs of patients at the same time a therapy for the disease has become more widely available. The test measures an isoform of phosphorylated tau protein in plasma. This isoform is phosphorylated at the 181 residue of the protein (p-Tau 181), and its concentration in plasma and cerebrospinal fluid, has been positively correlated to the presence of amyloid pathology in the brain, a hallmark of Alzheimer’s disease. LucentAD utilizes the Simoa p-Tau 181 assay that has been extensively studied in large longitudinal and cross-sectional cohorts, and its high specificity for amyloid pathology for AD has been well established through comparison to amyloid positron emission tomography, a gold standard for AD diagnosis. p-Tau 181 is a low-abundance protein in blood, requiring high analytical sensitivity for its reliable measurement. While the clinical validity of Simoa plasma p-Tau 181 measurements have been well studied, the test has also recently been shown to correlate with reduction in amyloid load in the brains of amyloid patients on anti-amyloid drug therapy, as demonstrated in the lecanemab (Leqembi) Clarity AD drug trial.

“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 Alzheimer’s disease,” said Masoud Toloue, CEO at Quanterix. “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 Alzheimer’s disease testing infrastructure.”