IHC/IF tissue biomarker assay development & validation for oncology clinical trials
Explicyte develops, validates and deploys single-plex IHC and multiplex IF tissue biomarker assays for oncology clinical trials, from assay optimization to analytical validation, scoring and trial-sample testing.
With 10+ years of histopathology and translational oncology experience, our ISO 13485 and ISO 9001-certified quality framework supports robust assay development, controlled documentation and downstream clinical use.
Explicyte is certified ISO 9001:2015 and ISO 13485:2016 by Euro-Quality System (certificates 260133/1637F/1 and 260133/1637F/2). Scope: Precision Oncology — design and development of tissue biomarkers, and tissue biomarker testing services to support therapeutic decision-making. The certification governs our histopathology workflow; the image-analysis pipeline is delivered by the same team but sits outside the certified scope.
Assay lifecycle
From biomarker concept to validated IHC/IF assay and trial deployment
A tissue biomarker assay has to do more than produce a convincing stain. It needs a defined intended use, controlled pre-analytics and staining, reproducible interpretation, predefined acceptance criteria and documentation that hold up across a clinical study.
Assay development
Build the method around its intended clinical use
We turn a biomarker hypothesis, an antibody or an existing research assay into a controlled single-plex IHC or multiplex IF method — defining intended use, specimen context, antibody and control strategy, staining conditions, multiplex architecture and the scoring approach.
Key outputs
- Intended-use definition and assay requirements
- Qualified antibodies, controls and optimized staining conditions
- Fit-for-purpose method, scoring framework and development report
Analytical validation
Prove fit-for-purpose performance against predefined criteria
Validation is scoped from the assay's intended use and risk profile, not a fixed checklist. We set the validation plan and acceptance criteria up front, then generate the analytical evidence — specificity, repeatability, reproducibility, robustness and scoring consistency — needed for consistent use across the study.
Key outputs
- Validation plan with predefined acceptance criteria
- Analytical performance and scoring-reproducibility data
- Controlled validation report and finalized assay documentation
Clinical deployment & lifecycle
Run it on trial samples — and keep the path open beyond the trial
The same team implements the validated assay on clinical-study samples within the certified quality framework, with controlled sample handling, run controls, scoring and reporting. The development package is maintained as a living record, so change control is documented and later transfer or further regulated development stays traceable.
Key outputs
- Controlled trial testing, scoring and reporting
- Deviation, retest and change-control management
- Living assay record supporting transfer or further development
Quality framework
ISO 13485:2016 & ISO 9001:2015
certified by Euro-Quality System
The certifications formalize the quality system used to control our stated tissue-biomarker development and testing activities — documented procedures, traceability and controlled assay records appropriate to clinical-stage sponsor requirements.
Certification covers the quality management system and its defined scope. It does not, by itself, make an assay a CE-marked IVD, companion diagnostic or otherwise approved test.
- Standards
- ISO 13485:2016 · ISO 9001:2015
- Certified by
- Euro-Quality System
- Certificate no.
- 260133/1637F/1 & 260133/1637F/2
- Certified scope
- Design & development of novel tissue biomarkers, incl. single-plex & multiplex IHC/IF panels; tissue biomarker testing to support therapeutic decision-making
- Application
- Precision oncology clinical trials
Featured validated assay
VALIDATED ASSAY — AVAILABLE NOW
Multiplex IF for standardized TLS detection & scoring
As the first biomarker assay developed under our certified quality framework, it delivers standardized detection and scoring of tertiary lymphoid structures in tumor tissue, interpreted by trained pathologists — available for oncology trials evaluating TLS as a biomarker of immunotherapy response.
Key outputs
- Predefined multiplex staining & scoring workflow for reproducible TLS assessment
- Pathologist-led interpretation against a standardized scoring framework
Selected pathology & TLS publications
contact our team
Discuss your tissue biomarker assay
Tell us the biomarker or panel, intended use, indication, trial phase, tissue type, available antibodies or existing method, expected sample volume and whether you need assay development, validation, clinical-trial testing or a combination. We'll help define the most appropriate development and validation plan within our certified quality framework.
Answers about ISO-certified pathology services
Frequently asked questions
Can Explicyte develop an IHC or multiplex IF assay from an early biomarker concept?
Yes. We can start from a biomarker hypothesis, an antibody, a preliminary staining protocol or an existing research assay. We define the intended use and specimen context, select appropriate controls, optimize staining and scoring, document the method and establish the analytical validation strategy required for clinical-trial use.
Can you take an existing IHC/IF assay and prepare it for use in a clinical trial?
Yes. We can review an existing sponsor-developed or transferred method, assess its current level of development, identify remaining gaps and define the additional optimization and analytical validation required before controlled testing of clinical-trial samples.
What does IHC/IF assay development include?
Assay development is tailored to the biomarker and intended use and can include antibody qualification, positive and negative control strategy, staining optimization, multiplex panel architecture, assessment of specimen and pre-analytical requirements, definition of the scoring method and preparation of controlled assay documentation.
What does analytical validation of a tissue biomarker assay include?
Validation is defined according to the assay’s intended use and risk profile rather than a fixed checklist. Depending on the assay, the validation plan can assess analytical performance, specificity, repeatability, reproducibility, robustness, scoring agreement, pre-analytical factors and predefined QC and acceptance criteria. The results are documented in a controlled validation report.
Is analytical assay validation the same as clinical validation of the biomarker?
No. Analytical validation demonstrates that an assay measures or scores the biomarker consistently for its defined intended use. Clinical performance evaluates the relationship between the biomarker result and a clinical condition or outcome, while clinical utility addresses whether use of the biomarker improves clinical decision-making or outcomes. These evidence packages require different study designs and are scoped separately.
What does ISO 13485 and ISO 9001 certification mean for my biomarker program?
Explicyte’s ISO 13485:2016 and ISO 9001:2015 certifications provide a documented quality-management framework for the certified scope of tissue biomarker development and testing. This includes controlled procedures, traceability and assay documentation appropriate to clinical-stage programs. Certification of the quality-management system does not, by itself, make an individual assay a CE-marked IVD or companion diagnostic.
Can Explicyte run the validated assay on samples from our clinical trial?
Yes. Once the assay is established and validated for its intended use, the same team can implement it on clinical-study samples with controlled sample handling, run-level controls, standardized scoring and reporting. Assay changes, deviations, repeats and revalidation requirements can also be managed throughout the study under the applicable quality procedures.
Can the assay development program support later transfer or companion-diagnostic development?
Yes. We can structure assay development, analytical validation and controlled documentation with downstream transfer or further regulated diagnostic development in mind. ISO 13485 provides a quality-management framework relevant to medical-device development, while the regulatory strategy, clinical performance requirements and any formal IVD or companion-diagnostic pathway are defined separately with the sponsor.
What information do you need to start an assay development or validation program?
We typically start with the biomarker or panel, intended use, indication and tissue type, available antibody or existing method, proposed clinical-study context, expected sample volume and timeline. From these elements, we can define the appropriate development, analytical validation and trial-deployment plan.
Do you already offer validated tissue biomarker assays?
Yes. Explicyte offers a validated multiplex immunofluorescence assay for standardized detection and scoring of tertiary lymphoid structures (TLS) in tumor samples, with interpretation by trained pathologists. Explore our dedicated TLS scoring service for assay requirements, workflow and supporting evidence.