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Home » Quanterix’s Alzheimer’s Blood Test Designated a Breakthrough Device
Quanterix’s Alzheimer’s Blood Test Designated a Breakthrough Device
The FDA has granted a Breakthrough Device designation to Quanterix’s Simoa phospho-Tau 181 (pTau-181) blood test for Alzheimer’s disease.
The assay measures the concentration of the pTau-181 protein in human serum and plasma using the company’s HD-X immunoassay system. The protein is a biomarker that suggests brain changes from Alzheimer’s, according to the National Institutes of Health.
The Quanterix test can “detect low-abundance markers in a blood sample, unlocking the possibility for earlier, more accessible, noninvasive diagnosis of disease, including [Alzheimer’s disease],” the company said.
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