US FDA Awards Amprion Breakthrough Device Designation


For Immediate 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 disease (PD).

San Francisco, California—Amprion announced its proprietary technology, Protein Misfolding Cyclic Amplification (PMCA), using CSF and plasma alpha-Synuclein (αS) to aid in the diagnosis of PD, 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./Ph.D. “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 personalized treatment. Our goal is to stop Parkinson’s on its destructive path,” added Dr. Lebovitz.

The FDA Breakthrough Devices Program is designed to speed up the development, assessment, and review of medical devices that provide 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, Ph.D., Amprion’s co-founder and the 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 significant. Our molecular diagnostics technology enables us to help pharmaceutical companies to develop biomarker-targeted drugs to stop or slow Parkinson’s.”

Dr. Lebovitz acknowledges the support of three key partners in developing 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 define better, 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, Ph.D., 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: Join The Fight for Brain Health.

Please Note: Important Billing Info

To improve patient access to the SYNTap® Biomarker CSF Test, Amprion offers the following billing options:

  • List price of $1500, with courtesy billing for both Medicare and private insurance.
  • An affordable self-pay price of $995 (patients may qualify for financial assistance and/or interest-free payment options).
  • Prices are effective as of January 1, 2024, and are subject to change.

Please note: Amprion is a Medicare participating provider, however, the SYNTap test does not currently have Medicare coverage determination. Also, Amprion is not yet in network with most insurers.

The SYNTap Biomarker CSF Test has been issued a dedicated CPT® PLA code to be used when billing: 0393U.

For additional information, please visit our billing page.