Comprehensive CNS & Neurodegenerative
Biomarker Testing
Advancing Drug Development Across the Neurodegenerative Spectrum
While the clinical presentation of neurodegenerative disorders varies widely, the underlying mechanisms of neuro-axonal damage, astrogliosis, and neuroinflammation often share common pathways. At MLM Medical Labs, we provide industry-leading fluid biomarker testing (blood and CSF) to support clinical trials targeting a broad spectrum of Central Nervous System (CNS) disorders.
Operating under strict CAP, CLIA, and ISO 15189 accreditations, our central laboratories deliver the high-precision data required to measure target engagement, patient stratification, and therapeutic efficacy across global multi-center trials.
Supported Disease Indications
Alzheimer’s Disease (AD) As a leading central laboratory for Alzheimer’s clinical research, we offer comprehensive assay validation and global testing services for critical blood-based and CSF biomarkers, including p-tau (181, 217), Amyloid beta (Abeta42/40 ratio), NfL, and GFAP. We offer fully validated Laboratory Developed Tests (LDTs) for AD biomarkers under the strict EU IVDR framework.
Parkinson’s Disease (PD) As the clinical landscape for Parkinson’s shifts toward disease-modifying therapies, robust fluid biomarkers are essential for tracking disease progression and therapeutic response. We support PD clinical trials with highly sensitive assays designed to detect neurodegeneration and structural brain damage long before clinical symptoms peak.
Multiple Sclerosis (MS) For demyelinating diseases like MS, monitoring subclinical disease activity is critical. We offer highly sensitive biomarker testing—such as Neurofilament light chain (NfL)—to help sponsors measure axonal injury, assess the efficacy of neuroprotective therapies, and track long-term disease stability.
Lewy Body Dementia (LBD) Characterized by a complex overlap of cognitive decline and motor symptoms, LBD requires highly precise diagnostic and prognostic tools. Our assay validation services ensure pharmaceutical sponsors have the reliable biomarker data necessary to differentiate LBD from other dementias and monitor trial endpoints accurately.
Multiple System Atrophy (MSA) MSA is a rare, rapidly progressive atypical parkinsonian disorder. Distinguishing MSA from Parkinson’s disease early in the clinical course is a major challenge for trial enrollment. We provide the advanced biomarker testing capabilities required to support diagnostic clarity and measure neuro-axonal degradation in MSA clinical cohorts.
Available CNS Biomarker Assays
MLM offers a comprehensive neurodegeneration biomarker portfolio spanning CSF and plasma matrices, with deep expertise in amyloid, tau, alpha-synuclein, and neuroinflammation – supported by industry-current instrumentation and fit-for-purpose validation across the full regulatory spectrum.
| Assay | Platform | CSF Status | Plasma Status |
|---|---|---|---|
| Amyloid & Protein Aggregation | |||
| Aβ40/42 Ratio | Lumipulse® | IVD CE-IVDR | - |
| Aβ42 | Lumipulse® | CE-IVDR | LDT (ratio only) |
| Aβ40 | Lumipulse® | CE-IVDR | RUO |
| p-Tau217/Aβ42 Ratio * | Lumipulse® | - | LDT IVDR |
| α-SynucleinLumipulse® G1200 only | Lumipulse® | RUO G1200 | RUO G1200 |
| β-SynucleinLumipulse® G1200 only | Lumipulse® | RUO G1200 | RUO G1200 |
| Tau Pathology & Axonal Damage | |||
| p-Tau 181cobas®: CSF FDA-cleared 2022 · Plasma FDA Oct 2025 + CE-IVDR | Lumipulse® cobas® | CE-IVDR FDA | RUO FDA CE-IVDR |
| p-Tau 217 | Lumipulse® | RUO | CE-IVDR LDT (US) |
| p-Tau 231 | MSD S-PLEX | RUO | RUO |
| Total Tau (t-Tau) | Lumipulse® | CE-IVDR | - |
| BD-TauBrain-derived tau · Lumipulse® G1200 only | Lumipulse® | - | RUO G1200 |
| NfLNeurofilament Light Chain | Lumipulse® | RUO | CE-IVDR |
| Neuroinflammation & Glial Activation | |||
| GFAPGlial Fibrillary Acidic Protein | Lumipulse® | - | RUO → LDT (pending) |
| sTREM2 | Lumipulse® | RUO | RUO |
| IL-6, TNF-α, IL-1β, CRP, CCL2 | MSD S-PLEX ELISA | RUO | RUO |
| Synaptic Integrity | |||
| Neurogranin, SNAP-25 | Lumipulse® MSD S-PLEX ELISA | RUO | - |
| NPTX2, VAMP2Lumipulse® G1200 only | Lumipulse® | RUO G1200 | RUO G1200 |
| Disease-Specific & Genetic | |||
| PSEN1/2, MAPT | Genotyping / PCR | RUO | - |
* 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). G1200 = available on Lumipulse® G1200 platform. Status reflects current availability; additional assays in validation.
Centralized Global Testing: All Patients Under One Roof
Eliminate inter-laboratory variability and streamline your global trial logistics. By partnering with MLM Medical Labs, pharmaceutical sponsors can route international clinical trial samples to a single, centralized facility.
Running all your patients “under one roof” ensures absolute data consistency, unified quality control, and seamless regulatory reporting.
CAP-Accredited & CLIA-Certified: Ensuring the highest level of data integrity for US and global trial submissions.
Custom LDT Capabilities: We offer comprehensive Laboratory Developed Test (LDT) validation for highly specialized CNS assays tailored to your specific trial endpoints.
EU IVDR Compliance: Deep expertise in navigating European regulatory frameworks for advanced diagnostic testing.
Partner With Our Scientific Team
Accelerate your CNS clinical trials with a central lab that understands the nuances of neurodegenerative research.