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Quanterix’s Simoa P-Tau 217 Blood Test Receives the US FDA’s Breakthrough Device Designation for Alzheimer’s Disease

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Quanterix’s Simoa P-Tau 217 Blood Test Receives the US FDA’s Breakthrough Device Designation for Alzheimer’s Disease

Shots:

  • The US FDA has granted breakthrough device designation to the company’s Simoa phospho-Tau 217 (p-Tau 217) blood test for the diagnosis of Alzheimer’s Disease (AD)
  • The Simoa p-Tau 217 test is a semi-quantitative in vitro diagnostic immunoassay that utilizes Quanterix HD-X immunoassay system to measure the concentration of p-Tau 217 in plasma
  • The test is indicated for patients with cognitive impairment & who are under evaluation for AD risk. The final diagnosis is done after interpreting the test results with other diagnostic tools

Ref: Quanterix | Image: Quanterix

Related News:- Quanterix Entered into a Collaboration with Eli Lilly to Develop Plasma-Based Biomarkers for Alzheimer’s Disease

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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