{"id":14637,"date":"2026-06-02T16:00:00","date_gmt":"2026-06-02T14:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=41dd6b6e4a2033266b8ef392a69aada0"},"modified":"2026-06-02T16:00:00","modified_gmt":"2026-06-02T14:00:00","slug":"neuropacs-announces-the-publication-of-a-new-study-comparing-the-first-of-its-kind-fda-de-novo-classified-imaging-biomarker-for-parkinsons-disease-with-csf-alp","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=14637","title":{"rendered":"Neuropacs Announces the Publication of a New Study Comparing the First\u2011of\u2011Its\u2011Kind FDA De Novo\u2013Classified Imaging Biomarker for Parkinson\u2019s Disease with CSF Alpha\u2011Synuclein Seed Amplification Assay"},"content":{"rendered":"

\nResearch from the University of Florida, Mayo Clinic, and Vanderbilt University, in collaboration with the Parkinson's Progression Markers Initiative, suggests that molecular and imaging biomarkers provide distinct information about Parkinson's disease.<\/i><\/p><\/a><\/a>

GAINESVILLE, Fla.--(BUSINESS WIRE)--Neuropacs\u2122 Corp., a leader in AI\u2011powered neurodiagnostics, today announced the publication of a seminal study co-authored by David Vaillancourt, PhD, the company\u2019s Co\u2011Founder and Chief Scientific Officer. The research published in Annals of Neurology reveals a positive alpha-synuclein (\u03b1-synuclein) seed amplification assay (SAA) and the automated imaging differentiation for parkinsonism (AIDP) provide unique information key to understanding Parkinson\u2019s disease (PD). The Neuropacs\u2122 software using the AIDP was granted de novo classification by the FDA, clearing the way for clinical use.<\/p>

\nThe publication is available online at https:\/\/onlinelibrary.wiley.com\/doi\/epdf\/10.1002\/ana.78252<\/a><\/p>

\nThe 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 \u03b1-synuclein protein \u2014 a hallmark of Parkinson's disease \u2014 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 \u03b1-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.<\/p>

\n\"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. \u201cThese findings have important implications for how clinicians and researchers evaluate patients with Parkinson's disease,\u201d stated Dr. Shannon Chiu, lead author on that manuscript. She added, \u201cBecause molecular confirmation of \u03b1-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 \u2014 particularly in the early stages of PD.\u201d<\/p>

\nAbout Neuropacs\u2122 Corp.<\/b><\/p>

\nNeuropacs\u2122 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\/<\/a><\/p>

\nAbout neuropacs\u2122<\/b><\/p>

\nneuropacs\u2122 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\u2019s disease (PD). Important Safety Information:<\/strong> The neuropacs\u2122 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\u2122 output.<\/p>

\nForward-Looking Statements<\/b><\/p>

\nThis communication includes express and implied \u201cforward-looking statements.\u201d Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as \u201cmay,\u201d \u201cmight,\u201d \u201cwill,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cobjective,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cpredict,\u201d \u201cpotential,\u201d \u201ccontinue,\u201d \u201congoing,\u201d or the negative of these terms, or other comparable terminology intended to identify statements about the future. By their nature, these statements are subject to numerous risks and uncertainties, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance, or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations, or otherwise, except as required by applicable law.<\/p>

\nFollow the Conversation<\/b><\/p>

\nStay up to date with the latest company announcements and industry insights by following @neuropacs on LinkedIn, X, and Instagram.<\/p> Contacts<\/b>

\nMedia Contact: <\/b>Martin Handfield, President & CEO, martin@neuropacs.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

Research from the University of Florida, Mayo Clinic, and Vanderbilt University, in collaboration with the Parkinson’s Progression Markers Initiative, suggests that molecular and imaging biomarkers provide distinct information about Parkinson’s diseas…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-14637","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14637","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=14637"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14637\/revisions"}],"predecessor-version":[{"id":14638,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14637\/revisions\/14638"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14637"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14637"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14637"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}