Amprion, a global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing, today announced a strategic licensing collaboration with MLM Medical Labs, a global central and specialty laboratory with operations in Germany. Through the agreement, Amprion will license its proprietary seed amplification assay (SAA) methodology, the technology that powers its SAAmplify®-αSYN test, to enable α-synuclein testing for biopharma-sponsored clinical trials in Europe. The collaboration expands access to pathology-based biomarker testing, helping accelerate neurodegenerative disease research and therapeutic development across Europe.

SAAmplify-αSYN is the only commercially available clinical CSF test service that detects misfolded α-synuclein aggregates, a key biomarker in synucleinopathies such as Parkinson’s disease, Lewy body dementia, multiple system atrophy (MSA), and Alzheimer’s disease with Lewy body co-pathology. SAAs can detect minute levels of misfolded protein in cerebrospinal fluid, providing insight into underlying disease biology that may not be apparent from symptoms or a clinical diagnosis alone.

Through a license agreement with Amprion, MLM Medical Labs will validate and perform seed amplification testing to detect misfolded α-synuclein as an in-house IVD at its laboratory in Germany, making testing available to biopharma sponsors conducting clinical trials throughout Europe.

“Neurodegenerative research is global, and access to pathology-based testing should be too,” said Russ Lebovitz, MD, PhD, CEO and co-founder of Amprion. “The demand for seed amplification testing from European researchers and biopharma sponsors is already strong. This collaboration will help identify the right patients for trials and produce richer data as we all work to better understand and treat neurodegenerative disease.”

To support continued international expansion and rising U.S. test demand, Amprion has established SAA Protein Manufacturing, LLC (SAAPM), a newly formed subsidiary company dedicated to the production of standardized protein substrates for seed amplification assays. Reliable, high-quality substrate production is fundamental to assay performance, reproducibility, and scalability. SAAPM was established not only to ensure a secure and scalable supply of substrates for Amprion’s expanding portfolio, but also to address a broader industry-wide demand for standardized substrates that improve consistency across neurodegenerative disease research, clinical testing, and drug development.

“Expanding access to innovative biomarker technologies is critical to advancing research in neurodegenerative diseases,” said Scott Houlton, CEO of MLM Medical Labs. “This collaboration with Amprion allows us to bring a highly differentiated and scientifically validated assay to sponsors conducting clinical trials in Europe, while supporting globally harmonized study designs.”

The collaboration strengthens Amprion’s growing international network of biopharma partnerships and expands access to α-synuclein seed amplification testing for multicenter clinical trials across Europe. Together with Amprion’s expanding manufacturing capabilities, the agreement supports the company’s broader strategy to advance biomarker-driven neurodegenerative disease research worldwide.

About SAAmplify-αSYN (formerly SYNTap®)

Amprion’s SAAmplify-αSYN test is a first-in-class qualitative Laboratory Developed Test and the only seed amplification assay available to aid the diagnosis of synucleinopathies such as Parkinson’s disease, Lewy body dementia and Alzheimer’s disease with Lewy body co-pathology. The U.S. Food and Drug Administration granted Amprion Breakthrough Device Designation in 2019 for use of the test as an aid in the diagnosis of Parkinson’s disease. The test became commercially available in the United States in 2021.

About Amprion

Amprion is the global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing. Amprion’s intellectual property surrounding seed amplification assay methodology extends to research, drug development and commercialization. SAAmplify-αSYN is the only seed amplification assay available to aid the diagnosis of synucleinopathies such as 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.

About MLM Medical Labs

MLM Medical Labs is a global central and specialty laboratory providing comprehensive support for clinical trials across all phases of drug development. With wholly owned laboratories in Europe, the United States and South Africa, MLM delivers laboratory services, customized solutions and integrated logistics to sponsors worldwide.

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