FDA letter supports use of new alpha-synuclein assay in trials - Parkinson's News Today
The FDA supports using the alpha-synuclein seed amplification assay (synSAA) to improve Parkinson’s and neurodegenerative disease clinical trials. Amprion’s SAAmplify-ɑSYN Biomarker Test, validated in 2023, is the only U.S. synSAA assay, aiding early Parkinson’s diagnosis. The FDA’s endorsement aims to accelerate treatment development and enhance trial efficiency.
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The FDA supports using the α-synuclein seed amplification assay (αSyn-SAA) biomarker in Parkinson disease (PD) clinical trials, based on data from the Parkinson's Progression Markers Initiative (PPMI) and other global studies. αSyn-SAA shows high diagnostic accuracy, distinguishing PD subtypes and detecting the disease before symptoms appear, potentially accelerating therapeutic development and personalized treatments.
FDA supports α-synuclein seed amplification assay (αSyn-SAA) biomarker in Parkinson disease (PD) clinical trials. Vesper Bio’s VES001, a frontotemporal dementia treatment, met all phase 1 end points. CT-132, a digital therapeutic, significantly reduced monthly migraine days in a phase 3 study.
FDA supports αSyn-SAA biomarker for Parkinson's research, following collaboration between MJFF and C-Path, to accelerate drug trials and therapeutic development.
The FDA supports using the alpha-synuclein seed amplification assay (synSAA) to improve Parkinson’s and neurodegenerative disease clinical trials. Amprion’s SAAmplify-ɑSYN Biomarker Test, validated in 2023, is the only U.S. synSAA assay, aiding early Parkinson’s diagnosis. The FDA’s endorsement aims to accelerate treatment development and enhance trial efficiency.