Amprion, a leader in advancing the diagnosis of neurodegenerative disorders through seed amplification testing, is unveiling its new line of cerebrospinal fluid (CSF) biomarker panels under the SAAmplify brand. These panels provide physicians and patients with the most comprehensive biomarkers for diagnosing Parkinson’s disease, Lewy body dementia, and Alzheimer’s disease with the Lewy body variant.
“Symptoms can often complicate diagnosis, leaving patients and caregivers without the critical insights needed to effectively manage their condition,” said Russell Lebovitz, MD, PhD, CEO and co-founder of Amprion.
Each SAAmplify panel utilizes Amprion’s flagship seed amplification assay (SAA) to detect misfolded ɑ-synuclein aggregates in CSF. Initially known as the SYNTap® Biomarker CSF test, the SAA has demonstrated autopsy-confirmed accuracy in detecting these aggregates. This assay is unique in its field and is advancing the understanding of neurodegenerative diseases characterized by abnormal α-synuclein accumulation, referred to as synucleinopathies.
Since its debut in 2022, Amprion has enhanced the assay’s sensitivity and reduced its processing time. The next-generation SAAmplify assay will be available in the latter half of 2024 and will be offered with additional biomarkers such as total Tau, pTau 181, Aβ1-42, Aβ1-40, and NfL, in various panel configurations.
“This level of accuracy offers unprecedented insight into the brain,” said Dr. Lebovitz. “These new panels will enable clinicians to diagnose both prodromal and symptomatic patients more effectively than ever before. We aim to bring much-needed clarity to those facing potential neurodegenerative diagnoses.”
Recent studies published in journals like The Lancet Neurology and Alzheimer’s and Dementia validate the high sensitivity and specificity of Amprion’s SAA for detecting ɑ-synuclein aggregates in CSF, with findings confirmed by autopsy.
“Accurate diagnosis is essential for developing a differential diagnosis for disorders with Lewy-body pathology or copathology,” said Dr. Marwan Sabbagh, neurologist at Barrow Neurological Institute and scientific advisor for Amprion. “Symptoms can obscure diagnosis, so it’s crucial for patients and caregivers to have the insights needed for effective management.”
Amprion will showcase the new SAAmplify panels at the Alzheimer’s Association International Conference (AAIC) 2024, the premier international event focused on dementia science and clinical practice.
About SAAmplify-ɑSYN (formerly SYNTap®)
SAAmplify-ɑSYN is a pioneering qualitative Laboratory Developed Test (LDT) and the only seed amplification assay designed to aid in diagnosing synucleinopathies such as Parkinson’s disease (PD), Lewy body dementia (LBD/DLB), and Alzheimer’s disease with Lewy body variant. The assay received Breakthrough Device Designation from the FDA in 2019 for PD diagnosis aid and was commercially launched in 2021.
About Amprion
Amprion is a global frontrunner in neurodegenerative disorder diagnosis through seed amplification testing. As the global population ages, Amprion is committed to advancing precision medicine by assisting biopharma partners in identifying new drug candidates and understanding disease pathologies. The amplification testing method was developed by Claudio Soto, PhD, Amprion’s Co-Founder and Professor at The University of Texas Health Science Center at Houston, and has been further validated by Amprion’s scientific team. Amprion holds numerous U.S. and international patents for SAA methodology and continues to develop new biomarker tests for early-stage neurodegenerative disorders.
