Biomarker Discovery
Biomarker Discovery Services
Comprehensive IHC, IF & ISH Solutions for Biomarker Discovery and Evaluation
Lanterne Dx provides end-to-end biomarker discovery support through high-quality immunohistochemistry (IHC), multiplex Immunofluorescence (mIF), and advanced in-situ hybridization (ISH) services. Our CLIA-certified, CAP-compliant laboratory delivers single-plex and custom multiplex assay development using both chromogenic and fluorescent detection systems.
With expertise spanning assay design, optimization, and analysis, we ensure reliable data acquisition, reproducible biomarker evaluation, and robust scientific insights to accelerate research and clinical programs.
Integrated Assay Development & Laboratory Services
Our team develops, optimizes, and executes biomarker assays tailored to the scientific and operational needs of each program. We offer advanced multiplexing strategies, including chromogenic and fluorescent staining, to support complex biomarker panels and high-information tissue profiling. Capabilities include:
- Antibody Development & Optimization
- Antibody Protocol Transfer
- Antibody Validation & Verification
- Custom Single-plex and Multiplex Assay Development (chromogenic or fluorescent)
- Automated staining for consistency, speed, and reproducibility
Flexible Analysis Options
Assay and panel development depend on accurate, reproducible results that can confidently support the transition from translational research to clinical application. Lanterne Dx employs both manual pathology review and advanced digital image analysis to ensure that every biomarker is evaluated with the rigor and consistency required across the development pipeline.
Our dual-modality approach enables:
- Expert qualitative and semi-quantitative assessment by board-certified pathologists
- Quantitative, scalable digital analysis for objective and reproducible measurement
- Data integrity and comparability suitable for translational, preclinical, and clinical programs
Biomarker Assay Validation
We develop and execute validation strategies to ensure accurate, reliable biomarker data.
Our goal is to demonstrate assay reliability while identifying, evaluating, and mitigating sources of variability.
Validation Approach
- Fit-for-Purpose Design – Tailored to the intended application of the assay
- Phased Execution – Flexible, staged validation to align with evolving program needs
- Regulatory Alignment – Study designs incorporate CAP, CLIA, FDA, and client-specific requirements
- Defined Parameters & Acceptance Criteria, including:
- Accuracy – Comparison to reference ranges or benchmark methods
- Sensitivity – Determination of LOD, LLOQ, and ULOQ
- Specificity/Selectivity – Verification of target-specific detection and interference assessment
- Precision – Repeatability and reproducibility across multiple conditions
- Stability – Evaluation of reagent or sample degradation under defined storage and use conditions
- Other Variables – Identification and testing of additional factors influencing assay performance
Validation Workflow
Our structured, transparent workflow ensures efficient, high-quality, and defensible assay validation:
