Quanterix Launches First pTau-181 Plasma Laboratory Developed Test for Clinical Diagnostic and Research Applications


A laboratory-developed test (LDT) to quantitatively measure phospho-Tau 181 (pTau-181) in plasma as a help in diagnostic assessment of Alzheimer’s disease has been validated, according to Quanterix Corporation, a business pushing the boundaries of discovery with ultrasensitive biomarker detection (AD). The Quanterix LDT is a quantitative immunoassay designed to determine the concentration of pTau-181 in human plasma. It was the first pTau-181 plasma test made available for clinical use in the United States. The test results must be interpreted in conjunction with other diagnostic tools if they are to be utilised in people who are being examined for AD and who present with cognitive impairment.

Phospho-tau isoforms are ideally situated to serve as the foundation for investigations into and diagnoses of AD pathogenesis. These proteins are particular for AD and can help a test that also uses less specific blood-based indicators of brain health, such amyloid beta and neurofilament light chain, become more sensitive and specific (NfL). To help advance the understanding of AD and other poorly known neurological disorders, a variety of assays encompassing these indicators have been developed on Quanterix’s ultrasensitive platforms, including in multiplex formats.

“Quanterix has long been dedicated to arming researchers and pharmaceutical companies with the unparalleled sensitivity to quantify biomarkers in less invasive samples such as blood, so they can advance our understanding and treatment of devastating neurological diseases such as Alzheimer’s”, “Today is a big, new translational step on our mission as our pTau-181 plasma test will aid in the diagnostic evaluation of patients suspected of having Alzheimer’s disease. Alongside our pTau-181 clinical test, we also continue to innovate by making markers like NfL available to advance neurodegenerative disease research and therapeutic clinical trials.”

Masoud Toloue, President and CEO, Quanterix Corporation

The Alzheimer’s Association International Conference (AAIC), which takes place in San Diego from July 31 to August 4, is where the Company will discuss the findings of its LDT validation research.

The pTau-181 LDT will be made available by Quanterix’ Accelerator Laboratory, which is a CLIA-licensed and ISO 15189 approved facility fully geared up to accommodate both clinical diagnostic testing and translational research.

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