The U.S. Food & Drug Administration (FDA) recently issued a Letter of Support (LoS) endorsing the use of the alpha-synuclein (α-syn) seed amplification assay (synSAA) in research and clinical trials. This assay has demonstrated exceptional specificity and sensitivity in detecting misfolded α-syn in cerebrospinal fluid (CSF). It is a valuable diagnostic tool for neurodegenerative disorders such as Parkinson’s and Alzheimer’s.
The synSAA test, developed by Amprion, is the only validated seed amplification assay available for diagnosing synucleinopathies, a group of neurodegenerative disorders associated with α-syn aggregation. The FDA’s LoS encourages the incorporation of synSAA into clinical trials to improve patient selection and enhance early intervention strategies.
Amprion’s assay has been extensively validated through peer-reviewed studies, confirming its high diagnostic accuracy. This accuracy is crucial in understanding the true value of biomarker tests, as clinical diagnosis of synucleinopathies can be error-prone. The positive results from numerous studies involving over 1,800 CSF samples have demonstrated the assay’s ability to detect diffuse Lewy body pathology with over 95% sensitivity and specificity.
Dr. Russell Lebovitz, Amprion’s CEO and co-founder, indicated that they are excited about the timing of this FDA support letter, and that it comes as the number of disease-modifying drug candidates in clinical development is increasing. Amprion has partnered with industry leaders on these trial advancements, recognizing the importance of the synSAA test in advancing early detection and treatment for neurodegenerative disorders.
Amprion holds worldwide SAA technology patents covering its process and critical components. The company offers various SAA-based services to pharmaceutical partners worldwide, empowering research and drug development efforts for neurodegenerative conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
