Posted by Michael Wonder on 12 Oct 2021
Quanterix granted breakthrough device designation from U.S. FDA for blood based pTau 181 assay for Alzheimer’s disease
11 October 2021 - Quanterix Corporation announced today that its Simoa phospho-Tau 181 (pTau-181) blood test has been granted breakthrough device designation by the U.S. FDA as an aid in diagnostic evaluation of Alzheimer’s disease.
The Simoa pTau-181 test is a semi-quantitative immunoassay intended for the measurement of pTau-181 concentration in human serum and plasma using the Quanterix HD-X immunoassay system.
