Quanterix announces validation of biomarker detection test to aid in diagnosis of AD

Quanterix Corp. announced the validation of a laboratory-developed test to quantitatively measure phospho-Tau 181 concentration in plasma to aid in the diagnosis of Alzheimer’s disease.

Per a company press release, this is the first pTau-181 plasma test released for clinical use in the United States. The test results are intended to be used in adults presenting with cognitive impairment who are being evaluated for AD and should be interpreted along with other diagnostic tools.

“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,” Masoud Toloue, Quanterix president and CEO, said in the release.

Phospho-tau isoforms are “uniquely positioned to anchor efforts to evaluate and diagnose AD pathology,” the company stated. The proteins, which are specific for AD, may increase the sensitivity and specificity of a test that uses less specific blood-based markers of brain health, such as amyloid beta and neurofilament light chain (NfL).

The pTau-181 test is one of many assays developed by Quanterix covering these markers, including in multiplex formats, to further advance the understanding of AD and other poorly understood neurological pathologies.

The company will present the results of its laboratory-developed test validation study at the Alzheimer’s Association International Conference July 31 to Aug. 4 in San Diego.