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Innovative blood test to diagnose Alzheimer's disease was recognized as a breakthrough medical device by the FDA

 Last Update: 2021-11-05
 Source: Internet
 Author: User

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On October 12, 2021, Quanterix announced that its blood test Simoa phospho-Tau 181 (pTau-181) has been granted a breakthrough medical device designation by the US FDA to assist in the diagnosis of Alzheimer's disease (AD)

Simoa pTau-181 is a semi-quantitative immunoassay method that measures the concentration of pTau-181 in the serum and plasma of patients

The Simoa pTau-181 detection kit targets the proline-rich region of Tau protein, which is highly conserved among these subtypes

▲Quanterix's technology platform can detect low abundance/concentration biomarkers in the blood (picture source: Quanterix's official website)

Reference materials:

[1] Quanterix Granted Breakthrough Device Designation from US FDA for Blood-Based pTau-181 Assay for Alzheimer's Disease.

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Innovative blood test to diagnose Alzheimer's disease was recognized as a breakthrough medical device by the FDA

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Courier blood test to diagnose Alzheimer's disease, innovative test was recognized by FDA as a breakthrough medical device