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MLM ONLINE ®

Search
MLM Medical Labs
  • Solutions
    • Central Laboratory Services
      • Study Startup
      • Safety Laboratory Testing
      • Data Management
      • Global Logistics Support
      • Clinical Trial Operations
    • Biomarker Solutions
      • Biomarker Testing
      • LDT & Assay Validation Support
      • Assay Development and Validation
      • Sample Processing
        • Global PBMC Services
        • Biomarker Applications
    • Specialty Testing
      • Flow Cytometry Services
      • Biomarker Applications
    • Sample & Logistics Services
      • Global Kit Building
        • Safeguard Box
      • Global Logistics Support
      • Biological Sample Management
    • Global Trial Access
      • Global Trial Network
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        • Cytespace Africa
      • Global PBMC processing
  • Therapeutic Expertise
    • Oncology
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      • Alzheimer’s Disease
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    • View all Therapeutic Areas
      • Cell & Gene Therapy
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  • Biomarkers in Alzheimer’s Detection
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ALZHEIMER'S BIOMARKER TESTING

Assure data consistency across sites and accelerate drug development by outsourcing Alzheimer’s biomarker testing to MLM Medical Labs. We are committed to advancing Alzheimer’s disease (AD) research and driving your program’s success through our comprehensive specialized biomarker testing services.

Comprehensive AD Biomarker Testing Services

Recent advances in blood-based biomarker detection have made it possible to measure plasma tau isoforms (p-tau181, p-tau217, and p-tau231) and neurofilament light chain (NfL) with high sensitivity, offering new promise for the early detection and monitoring of Alzheimer’s disease. In parallel, cerebrospinal fluid (CSF) testing continues to play a critical role, enabling the quantification of Aβ42, total tau (t-tau), and phosphorylated tau (p-tau) to support comprehensive neurodegenerative disease profiling.

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Available Alzheimer's Biomarker Assays

MLM offers a comprehensive Alzhimer’s biomarker portfolio spanning CSF and plasma matrices – supported by industry-current instrumentation and fit-for-purpose validation across the full regulatory spectrum.

Sources: Lumipulse® EU status per Fujirebio EU Neuro Test Panel chart (2026); US status per Fujirebio G1200 US regulatory chart (2026). cobas® Elecsys p-Tau181 status verified via public Roche sources (June 2026) - pending official Roche EU documentation.
Assay Platform CSF Status Plasma Status
Amyloid Pathology
Aβ40/42 RatioLumipulse®IVD CE-IVDR-
Aβ42Lumipulse®CE-IVDRLDT (ratio only)
Aβ40Lumipulse®CE-IVDRRUO
p-Tau217/Aβ42 Ratio *Lumipulse®-LDT IVDR
Tau Pathology & Neurodegeneration
p-Tau 181cobas®: CSF FDA-cleared 2022 · Plasma FDA Oct 2025 + CE-IVDRLumipulse® cobas®CE-IVDR FDARUO FDA CE-IVDR
p-Tau 217Lumipulse®RUOCE-IVDR LDT (US)
p-Tau 231MSD S-PLEXRUORUO
Total Tau (t-Tau)Lumipulse®CE-IVDR-
NfLNeurofilament Light ChainLumipulse®RUOCE-IVDR LDT (US)
Neuroinflammation & Glial Activation
GFAPGlial Fibrillary Acidic ProteinLumipulse®-LDT
sTREM2Lumipulse®RUORUO
Synaptic Integrity
Neurogranin, SNAP-25Lumipulse® MSD S-PLEX ELISARUO-
Disease-Specific & Genetic
PSEN1/2, MAPTGenotyping / PCRRUO-
Health Institution (EU IVDR): As a Health Institution under EU IVDR, MLM is authorized to develop, validate, and perform LDTs for clinical research - providing sponsors a regulatory-compliant path to deploy exploratory assays at LDT/IVDR status for EU studies, and under equivalent LDT frameworks for US studies.

* p-Tau217/Aβ42 ratio in plasma validated as IVD for US and LDT/IVDR for EU studies. CE-IVDR status per Fujirebio EU Neuro Test Panel chart (2026). cobas® Elecsys p-Tau181 CSF FDA-cleared 2022; Plasma FDA-cleared Oct 2025, CE-IVDR-marked EU (public Roche sources, June 2026). Status reflects current availability; additional assays in validation.

Whether your study requires p-tau biomarker identification or custom assay development, we can help. Though we tailor our services to your needs, generally, our testing process includes:

  • Collaborative study planning and setup: A dedicated project manager and experienced scientists will collaborate to strategically determine assay selection and sample types based on your timeline and protocol requirements. They'll rapidly develop quality-assured laboratory documentation and custom sample kits to meet visit-specific needs.
  • Simplified sample management: We offer complete sample tracking and traceability from the collection site to the designated lab. We also handle global logistics, ensuring compliance with temperature control requirements. You can access real-time sample data through our user-friendly online platform.
  • Standardized testing:We'll perform AD biomarker testing using standardized methods and state-of-the-art, high-throughput platforms to meet timelines and ensure data consistency. We can test on both plasma and CSF matrices for key AD biomarkers.
  • Seamless data transfer: We can seamlessly transfer data from our laboratory information management system to your preferred platform or design a custom interface for you. All data transfers are encrypted and compliant with 21 CFR Part 11.
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Why Choose Us for AD Biomarker Testing?

The team at MLM Medical Labs offers scientific rigor and expert guidance through every project. We understand the complexities involved in Alzheimer’s research and are determined to provide flexible biomarker testing services to meet your needs.

Specifically, when you choose MLM Medical Labs for your Alzheimer’s biomarker testing, you will benefit from our:

  • Expertise in centralized laboratory services: MLM Medical Labs has experience in central and specialty lab support dating back to 1993. Our leadership team meets and exceeds the qualifications needed to keep our processes in motion so we can best service your industry.
  • Commitment to quality and reliability: MLM Medical Labs is certified and accredited to the highest quality standards, including ISO, CAP and CLIA. We also operate in full compliance with EMA, FDA and GCLP guidelines to ensure reliable results and support regulatory approval.
  • Customized support and consultation: With decades of experience, our team recognizes that every clinical research trial is different. We offer fully customizable services, including expert support and consultation along the way.
  • Global reach without compromise: We support biopharmaceutical sponsors globally in generating high-quality, regulatory-grade data to advance Alzheimer's therapies. As a result, we offer our services worldwide, reaching across 70 countries and all the way to the International Space Station.

Contact Our Experts for a Proposal Today

If you’re ready to get started, contact our experts to learn more today. We look forward to seeing how we can work together to transform clinical research for Alzheimer’s disease.

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