Overview
Amprion Diagnostics offers the SAAmplify-ɑSYN test, a seed amplification assay that detects misfolded alpha-synuclein in cerebrospinal fluid (CSF) to aid diagnosis of synucleinopathies including Parkinson's disease, Lewy body dementia, multiple system atrophy, and Alzheimer's with Lewy body co-pathology. The test provides autopsy-confirmed accuracy, having analyzed over 20,000 samples, and supports treatment decisions with biological evidence. It has received US FDA Breakthrough Device Designation and is available through partnerships like Mayo Clinic Laboratories.
Frequently asked questions
- What is the SAAmplify-ɑSYN test and what does it detect?
- SAAmplify-ɑSYN is a qualitative laboratory-developed test that detects misfolded alpha-synuclein in CSF using seed amplification technology. It aids diagnosis of synucleinopathies such as Parkinson's disease, Lewy body dementia, multiple system atrophy, and Alzheimer's disease with Lewy body co-pathology, with autopsy-confirmed accuracy.
- What is the process for ordering and receiving SAAmplify-ɑSYN test results?
- Physicians order the test, collect CSF via lumbar puncture, and send the sample to Amprion's lab. The assay detects as few as 10 misfolded alpha-synuclein molecules, providing clear detected/not detected results to the physician for patient review, typically correlating with autopsy findings.
- What regulatory approvals and partnerships does Amprion have?
- The test has US FDA Breakthrough Device Designation. Amprion collaborates with Mayo Clinic Laboratories for US-wide access (Mayo ID: ASYNC) and has expanded partnerships in Australia, with technology validated across over 20,000 samples and 400+ autopsy confirmations.