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

U.S. FDA Grants Amprion Breakthrough Device Designation

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

For Immediate Release
May 22, 2019

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


The U.S. FDA Grants Breakthrough Device Designation For Amprion’s PMCA Tests For Detecting Misfolded Alpha-Synuclein (αSyn)–A Prion Known to Drive Parkinson’s Disease (PD)

San Francisco, California—Amprion today announced its proprietary technology, Protein Misfolding Cyclic Amplification (PMCA) using CSF and plasma alpha-Synuclein (αSyn) to aid in the diagnosis of Parkinson’s Disease, received a Breakthrough Device designation from the 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 the FDA to fast-track the development and review of our aSyn PMCA tests toward final regulatory approval. Early diagnosis of PD represents a giant leap for science to crack the code on this disease. Our goal is to stop Parkinson’s on its destructive path.”

The 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?

“This FDA Breakthrough Device Designation represents a monumental advancement in biomarker testing for PD. Traditionally, patients have been diagnosed based solely on clinical symptoms, which means by then this disease is relatively advanced,” explains Claudio Soto, Ph.D. Amprion’s co-founder and the chief scientific officer also serves as a 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 patients show PD symptoms. Amprion’s ability to detect misfolded Synuclein at early stages is significant, enabling us to work with pharmaceutical companies to develop biomarker-targeted drugs.”

Dr. Lebovitz acknowledges the support of three key partners in the development of Amprion’s breakthrough technology: The Michael J. Fox Foundation (MJFF) for Parkinson’s Research, the National Institutes of Health SBIR/STTR programs (NIH), and the 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.

Amprion anticipates commercial 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: Join The Fight for Brain Health.


About Amprion

Amprion pioneers Prion Early Detection Testing℠ for Alzheimer’s and Parkinson’s. Its breakthrough technology tracks specific Prion biomarkers including Abeta, Tau, and Synuclein, prior to any clinical symptoms using CSF and blood. Early detection accelerates drug development pathways to stop the disease. The company anticipates launching early detection diagnostics in the next 18 months. Learn more and Join The Fight for Brain Health #JTFBrainHealth at https://AmprionMe.com.

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