Neuropacs Announces the Publication of a New Study Comparing the First‑of‑Its‑Kind FDA De Novo–Classified Imaging Biomarker for Parkinson’s Disease with CSF Alpha‑Synuclein Seed Amplification Assay

Neuropacs™ Corp., a leader in AI‑powered neurodiagnostics, today announced the publication of a seminal study co-authored by David Vaillancourt, PhD, the company’s Co‑Founder and Chief Scientific Officer. The research published in Annals of Neurology reveals a positive alpha-synuclein (α-synuclein) seed amplification assay (SAA) and the automated imaging differentiation for parkinsonism (AIDP) provide unique information key to understanding Parkinson’s disease (PD). The Neuropacs™ software using the AIDP was granted de novo classification by the FDA, clearing the way for clinical use.

The publication is available online at https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.78252

The findings highlight that molecular and imaging markers of Parkinson’s disease may each capture distinct aspects of the disease process in its early stages. Alpha-synuclein SAA tests can accurately detect the presence of misfolded α-synuclein protein — a hallmark of Parkinson’s disease — in cerebrospinal fluid. However, until now, it remained unclear whether SAA positivity corresponded to broader patterns of brain degeneration visible on advanced neuroimaging. Using data from 462 participants in the Parkinson’s Progression Markers Initiative, researchers compared advanced MRI metrics between those who tested positive or negative for α-synuclein SAA. SAA-positive participants showed only one small focal brain difference in the superior cerebellar peduncle with no significant differences found in other MRI measures across the brain.

“Positive alpha-synuclein SAA confirms the underlying disease biology of Parkinson’s disease, but our findings show it did not strongly predict widespread microstructural brain changes on free-water imaging. This suggests that molecular and imaging markers may be capturing different dimensions of the disease, and both may be needed for a complete picture in early PD,” stated Dr. Vaillancourt. “These findings have important implications for how clinicians and researchers evaluate patients with Parkinson’s disease,” stated Dr. Shannon Chiu, lead author on that manuscript. She added, “Because molecular confirmation of α-synuclein aggregation and diffusion MRI appear to reflect different aspects of neurodegeneration, using both types of biomarkers together may provide a more comprehensive assessment of disease status — particularly in the early stages of PD.”

About Neuropacs™ Corp.

Neuropacs™ Corp. is an AI-enabled imaging company focused on developing software tools to support the evaluation of neurodegenerative diseases. Automated Imaging Diagnostics LLC, is a wholly owned subsidiary of Neuropacs Corp. Its platform leverages advanced imaging analytics to provide insights for clinical and research applications. https://neuropacs.com/

About neuropacs™

neuropacs™ is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes. The test requires a single, non-invasive, and radiotracer-free diffusion MRI scan, which can be acquired using standard diffusion MRI sequences available on 3 Tesla clinical MRI systems from Siemens, GE Healthcare, and Philips. The brain scan is analyzed using a rigorously validated free-water imaging model and machine learning algorithm. The device provides a classification report based on degenerative brain patterns of multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP) to help neuroradiologists and/or neurologists in differentiating these diseases from Parkinson’s disease (PD). Important Safety Information: The neuropacs™ system is intended to provide supplemental information and is not a standalone diagnostic device. Results should be interpreted in conjunction with clinical evaluation and other diagnostic testing. This device does not rule out other potential causes of Parkinsonism symptoms or signs and is intended to be used after all other potential causes of Parkinsonism symptoms (such as dementia with Lewy bodies, vascular Parkinsonism, drug-induced Parkinsonism, and corticobasal degeneration/syndrome) have been ruled out by trained clinicians on the basis of clinical, neurological, and other laboratory tests. Patient management decisions should not be based solely on neuropacs™ output.

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