FDA Grants Breakthrough Device Designation to Amprion’s PMCA Early Detection Tool
The U.S Food and Drug Administration (FDA) has granted a Breakthrough Device designation to Amprion’s proprietary technology, Protein Misfolding Cyclic Amplification (PMCA) — a device that holds the potential to diagnose Parkinson’s disease at a much earlier stage than current diagnostic methods.
If approved by the FDA, Amprion anticipates a market roll-out for PMCA tests as an early detection tool for Parkinson’s within the next 18 months.
There is no effective treatment for Parkinson’s, a progressive nervous system disorder that affects movement, largely due to the fact that there is no sensitive and objective laboratory test that can diagnose the disease at its early stages. Most patients are diagnosed due to clinical symptoms when the disease course is relatively advanced.
Amprion’s PMCA is able to circumvent this problem by tracking specific prion (proteins) biomarkers — in this case alpha-synuclein — in the cerebrospinal fluid (CSF) and blood prior to the onset of clinical symptoms. The CSF is the liquid surrounding the spine and brain.
“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,” Claudio Soto, PhD, Amprion’s co-founder and chief scientific officer, and a professor of neurology at McGovern Medical School at UTHealth, said in a press release.
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The FDA’s Breakthrough Devices program gives expedited review and assessment to medical devices that have the potential to be an effective treatment or diagnostic tool for life-threatening or irreversibly debilitating diseases. This allows these devices to reach the market faster.
“Prions are proteins gone rogue. This is a small victory in our war against Prions,” said Russ Lebovitz, MD, PhD, and Amprion CEO. “We are honored and look forward to working closely with FDA to fast-track the development and review of our aS [alpha-synuclein] 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.”
In addition to its value as a diagnostic test, the device may significantly contribute to medical research by providing scientists with a tool to study how alpha-synuclein contributes to Parkinson’s development.
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 were key partners in the development of PMCA.
“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, the foundation’s senior associate director of research partnerships.