FDA Issues ‘Letter of Support’ Encouraging Use of Synuclein-based Biomarker, αSyn-SAA, in Clinical Trials for Parkinson’s and Related Diseases

The FDA is encouraging scientists and drug developers to use the alpha-synuclein seed amplification assay (synSAA) to enhance clinical trials aimed at delaying or preventing Parkinson’s and other neurodegenerative diseases. This assay detects toxic protein clumps associated with these conditions. In a letter supporting C-Path’s Critical Path for Parkinson’s, the FDA recommends using synSAA to select trial participants and encourages sharing clinical data to build trust in the assay as a reliable biomarker. Currently, Amprion’s SAAmplify-ɑSYN Biomarker Test is the only validated synSAA in the U.S., improving Parkinson’s diagnosis, which was traditionally based on symptoms alone. The test was validated in 2023 using data from the Michael J. Fox Foundation’s Parkinson’s Progression Markers Initiative. It can detect synucleinopathies, including Parkinson’s, even before symptoms emerge, distinguishing different disease subtypes. Todd Sherer of the MJFF highlighted the FDA’s support as a key step in advancing Parkinson’s treatments. Amprion CEO Russell Lebovitz also welcomed the FDA’s backing, noting the growing number of drug candidates in development. The assay identifies misfolded alpha-synuclein in cerebrospinal fluid (CSF), acting as a diagnostic tool with high accuracy. The FDA’s support highlights the test’s role in early detection of Parkinson’s and other neurodegenerative diseases. Evidence shows the assay can identify Parkinson’s at an early stage, potentially speeding up drug trials and helping assess the effectiveness of new therapies. Amprion plans to expand testing to Europe by 2025.