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LDTs & Companion Diagnostic (CDx) Development

Translating Biomarkers Into Clinically Actionable Diagnostics

AxelaDx partners with biopharma innovators, diagnostic developers, and clinical laboratories to accelerate the development of Laboratory Developed Tests (LDTs) and Companion Diagnostics (CDx) that support precision medicine and improve patient outcomes.

Backed by Axela Biosciences’ multi-omics expertise, bioassay development infrastructure, and regulatory-aligned workflows, AxelaDx provides scientific depth and operational capability across the full diagnostic development continuum—from early feasibility through clinical launch readiness.

Whether you are enabling patient stratification, safety monitoring, therapeutic response prediction, or real-world evidence generation, we help transform your biomarker strategy into clinically actionable diagnostic solutions.

Our LDT Development Services

 

We support laboratories, diagnostic companies, and biopharma partners in designing and deploying high-performance LDTs that expand diagnostic access and advance clinical decision-making.

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Capabilities Include:

  • Feasibility & platform selection

  • Assay optimization (analytical & biological)

  • Analytical validation (CLIA-aligned)

  • Multi-site method and reproducibility studies

  • Performance characterization

  • LDT launch support and post-launch optimization

Platform Experience Includes:

  • Multiplex immunoassays (MSD, ELISA, Olink*)

  • Molecular and PCR-based assays

  • Neurology, oncology, inflammation, and infectious disease programs

Companion Diagnostic (CDx) Development

 

Enable Precision Therapeutic DecisionsFor therapeutic programs where biomarker-driven decision-making is critical, AxelaDx supports CDx co-development aligned with the needs of biopharma partners and regulatory pathways.

 

CDx Support Across the Development Lifecycle

•Biomarker correlation and clinical utility studies

•Assay design, selection, and technical assessment

•Analytical validation & bridging

•Clinical sample testing for pivotal trials

•Data generation for regulatory submissions

•Ongoing lifecycle management

 

Indications Supported:

•Oncology

•Neurology

•Inflammatory diseases

•Rare disease markets

•Emerging modalities (gene therapies, immunotherapies, targeted biologics)

Integrated Approach for Diagnostics Development AxelaDx’s diagnostic development model ensures scientific strength, operational efficiency, and compliance awareness throughout the lifecycle. StageAxelaDx Support Discovery & FeasibilityPlatform selection, biomarker expression studies Preclinical & TranslationalFit-for-purpose assays, model alignment Analytical ValidationPrecision, sensitivity, stability, reference range Clinical SupportTesting, sample handling, cohort management Regulatory & Pathway StrategyEvidence support for FDA/CLIA frameworks Post-Launch OptimizationPerformance monitoring, iterative improvements

Infrastructure & Platforms

•CLIA-certified laboratory

•Fully automated molecular diagnostic instruments

•Magnetic bead–based nucleic acid automation

•Immunoassay platforms (multiplex & single-plex)

•Digital imaging and pathology workflows

•Controlled and monitored sample management

•Kit development and logistics support for clinical studies

Why Work With AxelaDx

•Integrated diagnostics and scientific development ecosystem (via Axela Biosciences)

•Accelerated timelines for feasibility through clinical readiness

•Experience with complex biomarkers (neurology, oncology, inflammatory, multi-omics)

•Cost-effective partnership models for small and emerging biotechs

•U.S.-based laboratory and logistics center

•Transparent project management and collaborative engagement

Who We Support

•Biopharma developing precision therapeutics

•Diagnostic developers seeking CLIA deployment or CDx pathways

•Clinical laboratories expanding into new specialties

•University and hospital research programs

•Emerging biotech companies building biomarker-driven pipelines

Start Your LDT or CDx Development With Confidence

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AxelaDx provides the scientific, operational, and solution-driven partnership required to bring clinically impactful diagnostics to market.

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