Biomarker services for oncology trials
Make every trial biopsy count.
Explicyte has run clinical-stage biomarker programs in partnership with comprehensive cancer centers and industry sponsors since 2018.
Operating under an ISO-certified quality management system, we design workflows that reduce sample consumption, optimize turnaround and cost, and extract key insights from solid and liquid biopsies.
Recent papers based on clinical samples
From patient selection to in-human mechanism of action
Delivering clinical data that shape go/no-go decisions
In trials, biomarker analysis answers three key questions: which patients to enroll, whether the drug is engaging its target, and what the response — or resistance — is telling you.
Patient stratification
& selection
Find the right patient for the right drug: Gene-expression signatures, spatial immune scores and IHC/IF assay development to predict who benefits.
Pharmacodynamics
& target engagement
Show the drug is doing its job: Target occupancy, downstream signaling and cytokine modulation, in tumor and in blood.
Mechanism of action
in the clinic
Explain why it worked — or why it didn't. Deep immunophenotyping and spatial analysis of on-treatment biopsies to map how the tumor microenvironment evolves.
Biomarker analysis services to support oncology trials
Leveraging solid and liquid biopsies for clinical insights
Single-cell & spatial transcriptomics
Biomarker discovery & mechanistic studies
Single-cell and spatial transcriptomic readouts on trial samples to identify predictive biomarkers, signatures of response, resistance mechanisms, and how the investigational drug remodels biological programs.
DIGITAL PATHOLOGY (IF/IHC)
ISO-certified multiplex IF & IHC biomarker assays
ISO-certified development of multiplex IF/IHC assays (from design to validation) and clinical testing services — validated panels for TLS scoring and immune contexture— to support patient stratification.
Immune response profiling
Analysis of peripheral biomarkers
Immunophenotyping and cytokine analysis, complemented with transcriptomic and metabolomic readouts, to detect early signals of pharmacodynamic activity and target engagement in blood throughout the trial.
A dedicated infrastructure to support clinical trials
How we secure your clinical trial
Sample management
- ISO-certified quality system: sample and metadata registration with full traceability.
- Standardized sample processing & QC: reduced variability, better inputs.
- Safe storage & sample return.
Expertise & technologies
- Track record in biomarker study design, reducing sample use and optimizing turnaround and cost.
- The latest technologies to extract the most from every sample — a 10x Genomics Certified Service Provider across our platforms.
Actionable data
- Validated in-house processing workflow for fast remapping, cleaning, and annotation.
- In-house data scientists for rapid, personalized analysis — ready-to-publish figures with materials & methods.
Target & biomarker discovery testimonials
Sponsor stories
contact our team
Discuss your trial and request a quote
Whether you're planning the biomarker strategy for an upcoming trial or need analysis of samples already collected, we can scope the right assays, endpoints, and reporting — from patient stratification to on-treatment mechanism of action.
Answers about clinical trial biomarker services
Frequently asked questions
What biomarker services do you provide for clinical trials?
We support patient stratification, pharmacodynamic and target-engagement readouts, and mechanism-of-action analysis — across transcriptomic, multiplex protein, and blood-based assays.
What sample types can you process?
FFPE and fresh/frozen tumor cohorts, plus blood-based samples and other biological fluids. We process sponsor-provided clinical samples, including multicenter collections, and design workflows that limit sample consumption.
Is your work ISO-certified?
Yes — ISO 9001 and ISO 13485, scoped to our digital pathology and histology workflows.
Can you develop and validate a custom assay for our trial?
Yes. We design and validate multiplex IF/IHC assays — including panels for TLS scoring and immune contexture — to support patient stratification and exploratory endpoints.
Can you support patient stratification or companion diagnostic development?
We build stratification signatures and CDx-oriented biomarker work, aligned with the regulatory path your program is following.
How do you measure pharmacodynamics and target engagement?
Through target occupancy, downstream signaling, and cytokine modulation, read from tumor tissue and from blood across on-treatment timepoints.
Can you validate a biomarker before the trial starts?
Yes — candidate signatures can be tested in our 3D patient-derived tumor models before deployment, reverse translation that de-risks the readout on the bench rather than mid-trial.
Can you integrate clinical metadata and outcomes?
When available, we integrate clinical and pathological variables for subgroup and enrichment analyses, keeping all data de-identified.
How do you handle patient samples and data?
Every sample is registered and tracked under our quality management system, and data is handled de-identified.
What does a typical deliverable look like?
Analyzed datasets with publication-ready figures, full methods and QC documentation, and decision-oriented statistics.