Companion Diagnostic Testing

Streamline the Path from Development to Impact

What Is a Companion Diagnostic?

A companion diagnostic (CDx) is a specialized medical test—often a laboratory-based or in vitro diagnostic—that provides critical information for the safe and effective use of a specific drug or biological therapy. Companion diagnostic testing can help identify if a patient will benefit from a treatment or if they may be at increased risk for serious side effects.

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Superior Testing for Therapeutic Development with Versiti

Versiti Clinical Trial Services leads the way in Companion Diagnostic (CDx) assay development to advance therapies with precise, on-time delivery of actionable data for your unique project.

Our seamless service integration includes:

  • Assay development
  • Regulatory pathway mapping
  • Project and data management

Versiti’s long history of biopharma collaboration helps to streamline diagnostic development and regulatory approval for every project scope and phase.

Biomarker Lifecycle Chart

Our expertise spans Research Use Only (RUO) Assays, Laboratory Developed Tests (LDT) , In-Vitro Diagnostics (IVD), and Companion Diagnostics (CDx).

Research Use Only (RUO) Development
  • Custom assay development
  • Proof-of-concept studies
  • Specimen selection and stability studies
  • Analytical validation and platform/method comparison studies
Laboratory Developed Tests (LDT)
  • Custom assay development
  • Clinical validation and performance studies
  • CLIA, CAP, and FDA guideline compliance
In Vitro Diagnostics (IVD)
  • Full lifecycle development: concept to commercialization
  • Analytical and clinical validation
  • Regulatory strategy and submissions (such as FDA, CE-IVD, and others)
Companion Diagnostics (CDx)
  • Co-development with pharma partners
  • Biomarker discovery and validation
  • Regulatory strategy and FDA, CDRH, and/or EMA interactions
Get Started With Versiti

Versiti Diagnostic Lab Services

Our team of industry-leading experts is skilled in the following technologies:

Next Generation Sequencing (NGS)
  • HLA
  • HRD
  • RNASeq
  • T & B cell receptor seq
  • Microbial
Quantitative/Digital Polymerase Chain Reaction (qPRC/dPCR)
  • Gene expression
  • DNA copy number
  • Pathogen detection
  • Genotyping
  • Small RNA
Flow Cytometry
  • Immune cell profiling
  • Cytokine profiling
  • Characterization of engineering cells
Protein & Cell-Based Assays
  • ELISA
  • ELIspot
  • IHC/ICC
  • Cell imaging
Liquid Chromatography Mass Spectometry
  • Metabolomics
  • Proteomics
  • Lipidomics

A Methodology Built on Collaboration and Innovation

 

We utilize an integrated approach to understand your goals, communicate effectively, and deliver on prompt turnaround times. Our capabilities include:

  • Leveraging multiple scalable platforms to reliably meet different throughput requirements
  • Delivering high-quality solutions for both preclinical and clinical studies
  • An assay development process incorporating expert medical and scientific consultation to reflect relevant best practices
  • Testing capacity that spans from a few samples to thousands of samples
Connect with CDx Service Experts
 
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Versiti Clinical Trial Services provides central laboratory services, including sample testing, assay development, site management and more.
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HLA Testing & Cell Transplantation
Trust Versiti’s HLA Testing team for high-throughput, high-resolution typing solutions that support cell therapies and clinical development.
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Molecular Diagnostics and Infectious Disease Testing
Versiti delivers precision Molecular Diagnostics and Infectious Disease Testing backed by regulatory expertise and high-throughput capacity.
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