Amprion has entered a strategic licensing collaboration with MLM Medical Labs to expand α-synuclein seed amplification assay testing across Europe.
Under the agreement, Amprion will license the SAA methodology that powers its SAAmplify-αSYN test, enabling MLM to validate and perform seed amplification testing as an in-house IVD at a laboratory in Germany for biopharma-sponsored clinical trials throughout Europe.
The company claims SAAmplify-αSYN is the only commercially available clinical cerebrospinal fluid test that detects misfolded α-synuclein aggregates; it received U.S. Food and Drug Administration Breakthrough Device Designation in 2019 and became commercially available in the United States in 2021.
Amprion has also established SAA Protein Manufacturing, LLC to produce standardized protein substrates to support assay performance, reproducibility and scalability, and the company says the move and the MLM partnership will broaden access to pathology-based biomarker testing for neurodegenerative disease research.
MLM Medical Labs operates wholly owned laboratories in Europe, the United States and South Africa and provides laboratory services, customized solutions and integrated logistics for clinical trials.
