SAN DIEGO--(BUSINESS WIRE)--Amprion, a global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing, announces a groundbreaking paper in The Lancet Neurology. The study demonstrates the ability of the synuclein seed amplification assay (synSAA) to differentiate between Type 1 and Type 2 synuclein seeds, addressing the critical need for accurate diagnosis of multiple system atrophy (MSA). This fatal synucleinopathy is often misdiagnosed as Parkinson’s disease (PD), dementia with Lewy bodies (DLB), or other related disorders, delaying proper care and access to clinical trials.
MSA diagnosis has long been challenging due to overlapping symptoms with other neurodegenerative diseases and previously reported synSAA conditions have shown inconsistent results. These novel synSAA conditions reported by Amprion provide a breakthrough, by consistently and reproducibly distinguishing MSA from other synucleinopathies.
The study classifies synuclein seeds based on fluorescence levels: Type 1 seeds, linked to PD, DLB, and idiopathic REM sleep behavior disorder (iRBD), exhibit high fluorescence, while Type 2 seeds, associated with MSA, display intermediate fluorescence. Conducted across seven medical institutions in four countries, the study achieved 100% agreement with the gold standard of pathology for brain tissue and pathology-confirmed cerebrospinal fluid (CSF) samples. These results underscore synSAA’s potential for high-accuracy patient stratification, differential diagnosis, and early detection of MSA.
“Our results show that synSAA can differentiate the type of underlying synuclein neuropathology during life by means of CSF testing,” said Luis Concha, Head of R&D at Amprion and senior author of the study. “With that link clearly established, we are now ready to take the next step, which is scalability for commercial use and formal validation.”
These findings represent a significant advancement in addressing the diagnostic challenges of synucleinopathies, paving the way for earlier interventions and improved patient outcomes. The findings also set the stage for evaluating synSAA’s scalability and validation, bringing this innovative tool closer to clinical use.
“The clinical implications of this study are transformative,” said Russell Lebovitz, MD, PhD, CEO and co-founder of Amprion. “By identifying the underlying pathology of synucleinopathies, synSAA has the potential to reduce diagnostic delays and misdiagnosis rates for MSA, while also enabling better patient stratification for clinical trials.”
Amprion is now in the process of transferring the learnings from this work done in the company’s R&D lab into a commercial assay that incorporates components and methods that can withstand the rigors of CAP/CLIA standards and allow for use in clinical diagnosis/differentiation. Amprion anticipates the commercial/clinical launch of the MSA enhancement of the SAAmplify-asyn assay to occur during the second half of 2025.
About SAAmplify-ɑSYN (formerly SYNTap®)
Amprion's SAAmplify-ɑSYN Biomarker Test is a first-in-class-qualitative Laboratory Developed Test (LDT) and the only seed amplification assay available to aid the diagnosis of synucleinopathies such as Parkinson's disease (PD), Lewy body dementia (LBD/DLB), and Alzheimer's disease (AD) with Lewy body variant. The U.S. Food and Drug Administration (FDA) granted Amprion a Breakthrough Device Designation in 2019 for use of the test as an aid in the diagnosis of PD. SYNTap became commercially available in 2021.
About Amprion
Amprion is the global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing. Amprion’s intellectual property surrounding SAA methodology extends to research, drug development, and commercialization. SAAmplify-ɑSYN biomarker test (formerly SYNTap®) is the only seed amplification assay available to aid the diagnosis of synucleinopathies associated with Parkinson’s disease, Lewy body dementia, and Alzheimer’s disease with Lewy body co-pathology. Amprion is also accelerating precision medicine for neurodegenerative disorders by helping biopharma partners identify new drug candidates and underlying pathologies. Learn more at https://ampriondx.com/ or find us on LinkedIn.
