Companion Diagnostic Development & Validation Services
Accelerating Precision Medicine Through Companion Diagnostics
Companion diagnostics (CDx) are essential to the successful development and commercialization of targeted therapies. These tests identify the patients most likely to benefit from a treatment, help avoid unnecessary exposure to ineffective therapies, and support regulatory approval of precision medicines. The FDA defines a companion diagnostic as an in vitro diagnostic that provides information essential for the safe and effective use of a corresponding therapeutic product.
Companion Diagnostic Development & Validation Services
Accelerating Precision Medicine Through Companion Diagnostics
Companion diagnostics (CDx) are essential to the successful development and commercialization of targeted therapies. These tests identify the patients most likely to benefit from a treatment, help avoid unnecessary exposure to ineffective therapies, and support regulatory approval of precision medicines. The FDA defines a companion diagnostic as an in vitro diagnostic that provides information essential for the safe and effective use of a corresponding therapeutic product.
Our Expertise
Avance Biosciences provides CLIA-certified testing, biomarker assay development, analytical validation, clinical sample testing, and regulatory support for companies developing precision therapeutics. Our expertise in Next-Generation Sequencing (NGS), qPCR, ddPCR, and other molecular technologies enables pharmaceutical, biotechnology, and diagnostic companies to develop and validate biomarker assays that support companion diagnostic (CDx) programs from early biomarker discovery through clinical development.
Whether your program requires a single-gene qPCR assay, a targeted NGS panel, or a custom molecular biomarker assay, our scientific team provides assay development, analytical validation, CLIA testing, and clinical sample analysis to generate high-quality data supporting clinical decision-making, clinical trials, and regulatory submissions.
Our Companion Diagnostic Development Capabilities
Applications
Description
Services Include
Biomarker Strategy & Assay Design
Translate biomarker discoveries into analytically robust assays suitable for clinical development and companion diagnostic programs.
- Biomarker feasibility assessment
- Platform selection (qPCR, ddPCR, NGS, long-read sequencing)
- Clinical trial biomarker strategy
- Sample type selection (tissue, blood, plasma, PBMC, etc.)
- Cutoff determination
- Patient stratification strategy
- Assay design consultation
Molecular Assay Development
Develop fit-for-purpose molecular assays optimized for analytical performance and clinical trial implementation.
- qPCR assay development
- ddPCR assay development
- Targeted NGS panel development
- Custom biomarker assays
- Multiplex assay optimization
- Bioinformatics pipeline development
NGS-Based Companion Diagnostics
Comprehensive NGS solutions for genomic biomarker identification and characterization using validated laboratory and bioinformatics workflows.
- SNV and indel detection
- Gene fusion analysis
- Copy number variation (CNV)
- RNA biomarkers
- Minimal residual disease (MRD)
- Pharmacogenomic testing
- Targeted sequencing panels
- Whole-exome sequencing
- Custom oncology panels
qPCR & Digital PCR Companion Diagnostics
Highly sensitive targeted molecular assays for rapid biomarker detection and quantitative analysis.
- Mutation detection
- Gene expression biomarkers
- Copy number analysis
- Absolute nucleic acid quantification
- Variant allele frequency analysis
- Transgene detection
- Viral biomarkers
- Cell & gene therapy biomarkers
- MRD assays
CLIA-Certified Clinical Testing
CLIA-certified laboratory supporting biomarker testing for clinical trials and investigational companion diagnostic programs.
- Patient enrollment testing
- Patient stratification
- Biomarker testing
- Longitudinal patient monitoring
- Central laboratory testing
- Investigational CDx testing
- Clinical sample management
Analytical Validation Services
Design and execute analytical validation studies consistent with FDA expectations and CLSI best practices.
- Accuracy
- Precision
- Sensitivity
- Specificity
- Limit of Detection (LOD)
- Limit of Quantitation (LOQ)
- Linearity
- Reportable Range
- Reproducibility
- Robustness
- Ruggedness
- Sample Stability
Clinical Validation Support
Generate clinical evidence demonstrating that assay results identify the intended patient population for therapeutic use.
- Clinical sample testing
- Bridging studies
- Retrospective studies
- Prospective studies
- Biomarker prevalence studies
- Clinical performance assessments
- Multi-site testing strategies
Regulatory Support
Provide technical and documentation support for therapeutic and diagnostic co-development programs.
- Analytical validation documentation
- Clinical validation study support
- Technical reports
- FDA meeting support
- Regulatory data packages
- Risk assessment documentation
- Technology transfer documentation
Technology Transfer & Lifecycle Management
Support transition of validated assays into late-stage clinical development or commercial diagnostic laboratories.
- Assay transfer
- Method comparison
- Bridging studies
- Site qualification
- Instrument qualification
- Reagent qualification
- Change control support
- Post-validation performance monitoring
Why Avance Biosciences?
Whether you are developing a targeted oncology therapy, a gene editing treatment, or a precision medicine program driven by genomic biomarkers, Avance Biosciences can help you develop, validate, and implement the companion diagnostic strategy needed to identify the right patients and accelerate clinical development.
- CLIA-certified laboratory
- Extensive NGS expertise
- qPCR and ddPCR specialists
- Bioinformatics support
- Clinical trial testing capabilities
- Assay development and validation expertise
- Experience supporting regulated drug development programs
- Single partner from biomarker discovery through clinical validation
