FDA Breakthrough Device Designation For Detection Synuclein - Amprion

FDA Awards Amprion Breakthrough Device Designation For Detection of Alpha-Synuclein Associated with Parkinson’s Disease

By May 22, 2019 No Comments

Amprion is proud to announce that on May 1st its proprietary technology, Protein Misfolding Cyclic Amplification (PMCA) using CSF and plasma alpha-Synuclein (αS) to aid in the diagnosis of Parkinson’s Disease, received a Breakthrough Device designation from U.S. FDA. A Prion, misfolded alpha-Synuclein, is known to drive Parkinson’s Disease.

FDA’s Breakthrough Devices Program is designed to speed up development, assessment and review of medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Team Amprion anticipates market rollout of FDA-approved early detection testing for Parkinson’s within 18 months. We’re working hard to stop Parkinson’s on its destructive path!

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