Quanterix has announced the validation of a laboratory developed test (LDT) to quantitatively measure phospho-Tau 181 (pTau-181) in plasma as an aid in diagnostic evaluation of Alzheimer’s disease (AD).
Quanterix’s LDT – the first pTau-181 plasma test released for clinical use in the USA – is a quantitative immunoassay intended for the measurement of pTau-181 concentration in human plasma. The test results are intended to be used in adults presenting with cognitive impairment who are being evaluated for AD and must be interpreted in conjunction with other diagnostic tools.
Phospho-tau isoforms are uniquely positioned to anchor efforts to evaluate and diagnose AD pathology. These proteins are specific for AD and can serve to increase the sensitivity and specificity of a test that incorporates less-specific blood-based markers of brain health, such as amyloid beta and neurofilament light chain (NfL). A menu of assays covering these markers, including in multiplex formats, has been developed on Quanterix’s ultrasensitive platforms to further the company's goal of helping to advance the understanding of AD and other poorly understood neurological pathologies.
“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,” said Masoud Toloue, President and CEO, Quanterix Corporation. “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.”