Amprion's PMCA technology receives Breakthrough Device Designation from U.S. FDA
India, May 24 -- Amprion has announced thatits proprietary technology, Protein Misfolding Cyclic Amplification (PMCA) using CSF and plasma alpha-Synuclein (?S) to aid in the diagnosis of Parkinson's disease, received a Breakthrough Device designation from U.S. FDA.
"Prions are proteins gone rogue. This is a small victory in our war against Prions,"says Amprion CEORuss Lebovitz, M.D./PhD. "We are honored and look forward to working closely with FDA to fast-track the development and review of our aS PMCA tests toward final regulatory approval. Early diagnosis of Parkinson's represents a giant leap for science to crack the code on this disease. Our goal is to stop Parkinson's on its destructive path."
FDA's Breakthrough Devices Program is ...
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