The validation enables its use as a blood-based biomarker for inclusion and exclusion in clinical trials in both the United States and Europe.
MLM Medical Labs has completed validation of the Lumipulse G pTau217/Beta-Amyloid 1-42 Plasma Ratio assay as a Laboratory Developed Test under IVDR requirements, enabling its use as a blood-based biomarker for inclusion and exclusion criteria in Alzheimer’s clinical trials across the US and Europe.
The global central laboratory, which serves the biopharmaceutical industry, is the initial central lab in the EU to perform this specific biomarker ratio in clinical trials under the IVDR/LDT framework. While the Lumipulse assay recently received US Food and Drug Administration (FDA) clearance in the United States, it has not yet been reviewed by the European Union and remains classified as Research Use Only.
As a health institution, MLM is qualified to develop and validate LDTs that align with IVDR requirements for clinical research, allowing the company to offer the validated assay to sponsors conducting Alzheimer’s research in European markets.
“Achieving IVDR validation for the Lumipulse assay represents an important regulatory and scientific milestone for MLM,” says Scott Houlton, chief executive officer at MLM Medical Labs, in a release. “This achievement allows us to deliver an FDA-cleared and IVDR-validated diagnostic biomarker assay that supports Alzheimer’s disease research and early detection in both US and European patient populations.”
The Lumipulse assay measures the ratio of phosphorylated tau (pTau217) to Beta-Amyloid 1-42 in plasma, providing a minimally invasive approach to identify amyloid pathology—a defining characteristic of Alzheimer’s disease. The validation demonstrates the laboratory’s investment in regulatory excellence and enables sponsors to access data supporting early detection and therapeutic development.
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