MLM Medical Labs Validates Lumipulse® G pTau217/Beta-Amyloid 1-42 Plasma Ratio Assay Under IVDR/LDT Framework

First central lab in EU to perform this blood-based assay under IVDR/LDT regulations, supporting inclusion and exclusion criteria in Alzheimer’s clinical trials

MöNCHENGLADBACH, NORTH RHINE-WESTPHALIA, GERMANY, November 3, 2025 /EINPresswire.com/ -- MLM Medical Labs (MLM), a global central and specialty laboratory serving the biopharmaceutical industry, announced the completed validation of the Lumipulse^® G pTau217/Beta-Amyloid 1-42 Plasma Ratio assay as a Laboratory Developed Test (LDT), enabling its use as a blood-based biomarker for inclusion and exclusion in clinical trials in both the United States and Europe.

While the Lumipulse G pTau217/Beta-Amyloid 1-42 Plasma Ratio assay recently received FDA clearance in the United States, it has not yet been reviewed by the European Union and is therefore 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.

MLM Medical Labs is the first to validate and perform this specific biomarker ratio in clinical trials under the IVDR/LDT framework. This milestone gives Sponsors access to a validated, regulatory-compliant biomarker tool that supports Alzheimer’s disease research and the evaluation of inclusion and exclusion criteria in clinical trials.

“Achieving IVDR validation for the Lumipulse assay represents an important regulatory and scientific milestone for MLM,” said Scott Houlton, CEO, MLM Medical Labs. “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 U.S. and European patient populations.”

The Lumipulse assay measures the ratio of phosphorylated tau (pTau217) to Beta-Amyloid 1-42 in plasma, offering a minimally invasive approach to identify amyloid pathology - a defining characteristic of Alzheimer’s disease. The test’s validation demonstrates MLM’s continued investment in scientific advancement and regulatory excellence, enabling Sponsors to access data that support early detection and therapeutic development with precision and reproducibility.

As a health institution, MLM is permitted to develop and validate Laboratory Developed Tests (LDTs) to support specialized clinical and translational research. This scientific autonomy, combined with IVDR-aligned processes, ensures high-quality biomarker testing that meets the latest regulatory and scientific standards.

MLM continues to expand its scientific and analytical capabilities to support the growing demand for validated biomarker testing in neurodegenerative disease research - reinforcing its position as a trusted partner in advancing Alzheimer’s diagnostics and drug development.

About MLM

MLM is an international specialty and central laboratory with dedicated, harmonized locations in Europe and North America. MLM ‘s international team of highly skilled and experienced employees supports over 300 clinical trials at any given time and has supported thousands of clinical programs over the past 25 years. MLM offers a broad range of services with an assay portfolio of over 1,500 parameters, including central lab testing, analysis of biomarkers, assay development, kit building, and long-term sample management and storage. The company is headquartered and owns laboratories in Mönchengladbach, Germany and owns and operates laboratories in Memphis, TN and City of Tshwane, South Africa. Its global laboratory network spans 90+ countries and 5 continents. For more information, please visit www.mlm-labs.com

Michael Howell
MLM Medical Labs
michael.howell@mlm-labs.com
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