Validated IVDR/LDT Biomarker
Testing for Alzheimer’s Research
First in Europe. Ready for Global Trials.
MLM Medical Labs is the first laboratory in Europe to validate the Lumipulse® G pTau217/Beta-Amyloid 1-42 Plasma Ratio Assay as a Laboratory Developed Test (LDT) under the IVDR framework — expanding the FDA-cleared assay’s utility for Alzheimer’s clinical studies across both the U.S. and EU.
Extending Diagnostic Reach. Enhancing Clinical Confidence.
Regulatory Alignment and Analytical Excellence
Validated under the IVDR as an LDT in the EU and FDA-cleared in the U.S., this assay delivers consistent, high-quality plasma biomarker data that meet rigorous analytical and regulatory standards.
Enabling Global Trial Inclusion
The assay supports patient inclusion and exclusion decisions in Alzheimer’s clinical trials, ensuring harmonized biomarker strategies across global study populations.
Data You Can Trust
With proven precision, sensitivity, and reproducibility, the Lumipulse® G pTau217/Beta-Amyloid 1-42 Plasma Ratio Assay empowers sponsors to:
■ Streamline recruitment and site qualification
■ Align biomarker data across U.S. and EU studies
■ Accelerate biomarker-driven development programs
Comprehensive Biomarker Testing for Global Alzheimer’s Disease Trials
The MLM team brings more than 30 years of expertise in delivering comprehensive central and specialty lab support for complex global clinical trials, including Alzheimer’s and Parkinson’s disease research.
Cutting-Edge Biomarker Solutions
We offer a robust portfolio of neurodegeneration biomarkers, ensuring high-quality, reliable data to advance your research. Need additional exploratory assays? We support assay qualification and validation to meet your study’s specific needs.
Available Biomarkers & Platforms
*p-tau 217/Aβ42 ratio in plasma is validated as IVD in US and LDT in EU (~IVD)
**We also support qualification and validation of additional exploratory assays.
Overview of Biomarkers in Neurodegenerative Disease
Biomarkers are measurable indicators of biological conditions. In neurodegenerative diseases, they reflect changes such as amyloid-beta accumulation, tau pathology, and neuronal loss.
Cerebrospinal Fluid (CSF) Biomarkers
■ Amyloid-beta 42 (Aβ42): Decreased CSF levels indicate plaque formation in the brain.
■ Total Tau (t-tau): Elevated levels suggest neuronal damage and neurodegeneration.
■ Phosphorylated Tau (p-tau): Increased levels reflect Alzheimer’s-specific neurofibrillary tangles.
Blood Biomarkers
■ Plasma Tau (p-tau181, p-tau217, p-tau231): Elevated levels correlate with tau pathology in AD.
■ Neurofilament Light Chain (NfL): Indicates axonal damage and neuronal loss.
Plasma p-tau217: A Transformative Biomarker
Recent studies highlight plasma p-tau217 as one of the most promising biomarkers for Alzheimer’s disease, demonstrating high sensitivity and specificity for detecting pathology — even in early stages.
Key Advantages:
■ Differentiates Alzheimer’s from other dementias with high accuracy
■ Strong correlation with amyloid and tau pathology confirmed by PET and CSF
■ Detectable in preclinical and early symptomatic stages
■ Non-invasive and scalable for clinical trial deployment
Clinical Trial Applications:
■ Screening and enrolling participants with early Alzheimer’s pathology
■ Monitoring disease progression
■ Potential surrogate endpoint for treatment efficacy
The MLM Advantage:
The Lumipulse® G pTau217/Beta-Amyloid 1-42 assay, validated under IVDR/LDT by MLM Medical Labs, represents a major step forward in enabling blood-based biomarker testing for Alzheimer’s disease. Combined with our comprehensive biomarker portfolio and 30 years of global central and specialty lab experience, MLM is uniquely positioned to accelerate your therapeutic development in neurodegenerative disease research.
Connect With MLM Medical Labs Today
Reach out to our team to learn how our scientifically validated, regulatory-compliant solutions can advance your global Alzheimer’s disease trial.
