FDA Breakthrough Device Designation For Detection Synuclein - Amprion
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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 the U.S. FDA has awarded the company a Breakthrough Device Designation for detecting alpha-Synuclein (αS) in the diagnosis of Parkinson’s Disease on May 1st, 2019. A type of misfolded protein, alpha-Synuclein, is known to drive Parkinson’s Disease. Amprion’s proprietary technology, Protein Misfolding Cyclic Amplification or PMCA, detects misfolded synuclein using spinal tap (Cerebrospinal fluid/CSF) and blood.

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 testing for Parkinson’s within 18 months. We’re working to end Parkinson’s disease. By enabling people to test for Parkinson’s early, decades before any symptoms, we empower people to take preventive brain care, while accelerating drug development for personalized treatment.

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Press Release: May 22, 2019

Amprion Joins the Fight Against Parkinson’s Through Early Detection Testing

FDA Grants Breakthrough Device Designation For Amprion’s PMCA Tests For Detection of Misfolded Alpha-Synuclein, Prion Known to Drive Parkinson’s

San Francisco, California—Amprion today announced 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.

“Prions are proteins gone rogue. This is a small victory in our war against Prions,” says Amprion CEO Russ 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 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.

Parkinson’s Disease currently affects approximately 10 million people worldwide. Despite tremendous capital expenditures in research and drug development, there are still no effective treatments. Why?

“There is no specific, sensitive and objective laboratory test for the diagnosis of Parkinson’s Disease presently. Patients are now diagnosed based on clinical symptoms, which means the disease is relatively advanced,” explains Claudio Soto, PhD, Amprion’s co-founder and chief scientific officer who also serves as professor of neurology at McGovern Medical School at UTHealth. “Our PMCA test tracks alpha Synuclein, a protein that misfolds into toxic shapes in the brain and this likely begins decades before disease symptoms. Amprion’s ability to monitor Misfolded Proteins at early stages is both significant and meaningful. This enables us to work with major pharmaceutical companies to develop Prion-targeted drugs to stop or slow the disease.”

Dr. Lebovitz acknowledges the support of three key partners in the development of Amprion’s breakthrough technology: The Michael J. Fox Foundation for Parkinson’s Research, National Institutes of Health SBIR/STTR programs, and McGovern Medical School at the University of Texas Health Science Center at Houston.

“Efforts across Parkinson’s research seek to better define, measure and treat alpha- synuclein pathology. This assay is a valuable tool in that work, and we’re proud that The Michael J. Fox Foundation could partner toward its development with funding, samples and consult,” said Samantha Hutten, PhD, Senior Associate Director of Research Partnerships at The Michael J. Fox Foundation for Parkinson’s Research.

The company anticipates market rollout of FDA-approved early detection testing for Parkinson’s within 18 months. Sign up for breakthrough updates from the forefront of the Prion War:

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