Neurology & CNS Bioanalytical CRO Services
As a full-service bioanalytical CRO, KCAS Bio supports neurology and CNS drug programs with ultrasensitive biomarker, PK and PD assays in blood, CSF and tissue. We work with small molecules, biologics and oligonucleotides, from preclinical studies through Phase 2b/3.
Rapid advances in neurological treatments
Neurological drug programs rely on biomarkers that are present at very low concentrations, change slowly and are hard to sample. Whether the target is Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, Amyotrophic Lateral Sclerosis, frontotemporal dementia, Lewy body dementia, Progressive Supranuclear Palsy, Multiple Sclerosis or another neurological condition, three challenges recur: ultra-low-abundance targets such as NfL, p-tau and TDP-43; plasma and CSF behaving differently; and limited sample volume from lumbar punctures, tissue and repeat visits. KCAS Bio matches the platform to the question, from ultrasensitive blood-based assays to multiplex discovery panels, in plasma, CSF and tissue.
Services for neurological drug development
KCAS Bio offers a full range of bioanalytical and biomarker services, and we adapt each method to your molecule, matrix and stage of development.
Biomarker testing
Biomarker testing for neurodegeneration, neuroinflammation and neuronal damage markers
Pharmacodynamic and target engagement assays
Pharmacodynamic and target engagement assays, including ultrasensitive custom single-plex or CNS panels for multiplex.
Pharmacokinetic assays
Pharmacokinetic assays for biologics and small molecules in plasma and CSF
Hybrid LC-MS/MS
Hybrid LC-MS/MS for selective protein quantification where ligand binding lacks specificity
Immunogenicity testing
Immunogenicity testing for antibody-based neurotherapeutics
qPCR and ddPCR
qPCR and ddPCR assays for gene therapy and oligonucleotide programs
Technology we use for Neurology/CNS programs
Among our platforms, these add particular value for neurology/CNS programs:
• NULISA™ CNS Disease Panel 120+: multiplex CNS profiling from low sample volume
• NULISA custom single-plex: ultrasensitive assays for low-abundance targets
• NULISA for EV-derived biomarkers alongside plasma & CSF
• Simoa®: digital immunoassays for NfL, GFAP & tau
• MSD S-PLEX Custom Human Neurology Kit
We have advanced technology to move your science forward. Speak with a KCAS Bio expert now.
Sample types & modalities supported for Neurology/CNS programs
Sample types
- CSF
- Plasma
- Brain tissue
- PBMC lysate
- Urine
- Plasma/CSF-derived EVs (exploratory)
Blood and EVs: plasma and EV-derived biomarkers offer a less invasive route to CNS signal and allow repeat sampling across a study. We run plasma and CSF side by side to confirm which matrix fits your question.
Modalities
- Small molecules
- Monoclonal antibodies
- Bispecific and brain-shuttle antibodies
- Antisense oligonucleotides (ASO)
- siRNA
- AAV gene therapy
- Enzyme replacement (CNS-delivered)
- Cell therapy
- Peptides
- Vaccines and active immunotherapy
- Antibody-oligonucleotide conjugates
- Protein degraders
KCAS Bio scientific insights
Blogs
Neurodegenerative diseases affect millions worldwide. Fifty million people are living with Alzheimer’s disease or other dementias. Although Alzheimer’s disease is one of the most recognized, it is just one of many neurological disorders, such as Multiple Sclerosis, Parkinson’s, or Huntington’s disease. These conditions lead to a…
Blogs
What Are Ligand Binding Assays (LBAs)? Ligand binding assays (LBAs) have been our core activity for decades. LBAs are commonly used to measure interactions between two proteins, a ligand and its receptor, a monoclonal antibody (mAb) and its target, or a biologic and Anti-Drug Antibodies (ADA). What Are…
Posters & Papers
Please download this poster, “Performance of a method for quantifying progranulin as a target engagement biomarker for azp2006 in progressive supranuclear palsy.”
FAQs for Neurology & CNS programs
Which biomarkers can you measure in neurodegenerative disease studies?
Our menu includes NfL, Nf-H/pNf-H, GFAP, total tau, p-tau181, p-tau217 and p-tau231, Aβ40 and Aβ42, TDP-43, neurogranin, progranulin, sTREM2, YKL40 and cytokines, plus custom targets. For broad discovery, the NULISA CNS Disease Panel 120+ profiles around 120 markers at once; for a single low-abundance target, we develop custom assays.
Can you quantify neurodegeneration biomarkers in blood, not only CSF?
Yes. We develop and run assays in plasma as well as CSF, using ultra-sensitive platforms such as Simoa and NULISA for low-abundance targets. Blood allows repeat sampling and larger cohorts, but markers do not always track identically across matrices, so we can run both in parallel and help you decide which matrix answers your question.
Do you work with extracellular vesicles?
Yes, on an exploratory basis. We have generated preliminary data on EV-derived biomarkers alongside plasma and CSF in ALS and Alzheimer’s disease, using a 120-plex neurological NULISA panel. EVs can carry brain-derived proteins into the bloodstream, which makes them an attractive, less invasive window on CNS pathology. Contact us to discuss feasibility and isolation approach for your study.
What phases, species and modalities do you support?
Preclinical studies in mouse and non-human primate through Phase 2b/3 clinical trials, across Alzheimer’s, Parkinson’s, ALS, MS and PSP programs. We support small molecules, antibodies, bispecifics and oligonucleotide therapeutics, and qPCR/ddPCR assays for gene therapy. Methods are fit for purpose, from proof-of-concept to GLP-compliant, matched to your context of use.
Tell us how we can help with your project
We've earned our reputation for delivering reliable, error-free data. We understand the importance of speed, flexibility, and consistency and only make promises we can keep.