MLM Medical Labs Deploys IVDR-Validated LDT for pTau217/Aβ42 Ratio in Regulatory Approved Trial

MLM’s IVDR-validated LDT is now in use in MHRA- and CTIS-approved European clinical trial settings

Mönchengladbach, Germany – April 15, 2026

MLM Medical Labs (MLM), a global central and specialty laboratory, today announced that the Fujirebio Lumipulse® G pTau217/β-amyloid 1-42 plasma ratio assay – validated in 2025 by MLM as a Laboratory Developed Test (LDT) under the IVDR framework – is now actively being used to support inclusion and exclusion decisions in clinical trial settings in Europe, following review and approval by European regulatory authorities.

This milestone builds on MLM’s previously announced LDT/IVDR validation of the assay in the European Union, enabling its use as a blood-based biomarker in clinical research settings.

“Transitioning from validation to active use in a regulatory-approved clinical trial represents a significant step forward,” said Dr. Stephan Voswinkel, Managing Director at MLM Medical Labs. “It demonstrates both the scientific robustness of our LDT/IVDR approach and the confidence of regulatory authorities and sponsors in using this biomarker ratio to support critical study decisions.”

Advancing Neurodegenerative Research with Validated Biomarker Testing
The Lumipulse® assay measures the ratio of phosphorylated tau (pTau217) to β-amyloid 1-42 in plasma, providing a minimally invasive method to identify amyloid pathology, one of the defining characteristics of neurodegenerative diseases such as Alzheimer’s disease.

As a health institution under IVDR, MLM is permitted to develop and validate Laboratory Developed Tests to support specialized clinical research. This capability enables sponsors to:

• Incorporate validated biomarker-based inclusion/exclusion criteria
• Align with evolving European regulatory expectations
• Improve patient stratification and trial efficiency

A Strategic Partner in Neurodegenerative Clinical Development
With deep expertise in biomarker testing and global clinical trial support, MLM continues to expand its role in advancing precision diagnostics in neurodegenerative disease research.

This latest milestone reinforces MLM’s position as a trusted partner capable of bridging scientific validation, regulatory alignment, and real-world clinical trial execution.

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