Amprion, a company specialising in the development of diagnostic tools for neurodegenerative disorders, has announced the launch of SAAmplify, a new line of cerebrospinal fluid (CSF) biomarker panels.
This latest offering aims to provide physicians and patients with an extensive set of biomarkers to assist in diagnosing conditions such as Parkinson’s disease, Lewy body dementia, and Alzheimer’s disease with the Lewy body variant.
The SAAmplify panels utilise Amprion’s flagship seed amplification assay (SAA), which detects misfolded ɑ-synuclein aggregates in CSF. This technology, previously known as the SYNTap Biomarker CSF test, enables the identification of these aggregates with a level of accuracy confirmed by autopsy.
According to Amprion, SAA is currently the only ɑ-synuclein assay of its kind. It contributes to a proposed new classification of neurodegenerative diseases, known as synucleinopathies, characterised by the abnormal build-up of alpha-synuclein protein in the nervous system.
Since the initial launch of the assay in 2022, Amprion said that it has made significant improvements to its sensitivity and reduced the time required for testing.
The next-generation assay, marketed under the SAAmplify brand, is set to be available in the latter half of 2024.
The new panels will also incorporate additional common biomarkers, including total Tau, pTau 181, Aβ1-42, Aβ1-40, and NfL, in various combinations alongside SAAmplify-ɑSYN.
Amprion plans to introduce the new SAAmplify test panels at the Alzheimer’s Association International Conference (AAIC) 2024, offering a comprehensive tool for the early and accurate diagnosis of neurodegenerative diseases.
Amprion CEO and co-founder Russell Lebovitz said: “This level of accuracy is like having a window into the brain itself.
“With these new panels, clinicians will have the biological insights to develop a diagnosis for prodromal and symptomatic patients alike, which has never before been possible. Patients navigating a potential neurodegenerative disorder diagnosis are often met with unclear answers.”
Earlier this year, Amprion obtained European patents for its seed amplification assay platform. These fundamental patents, issued in the European Union and the UK, extend Amprion’s coverage in crucial regions.
The patents broadly apply to methodologies, including SAA, Protein Misfolding Cyclic Amplification (PMCA), and Real-Time Quaking-Induced Conversion (RT-QuiC).
