Biomarker, Assay Development & HLA Typing

Comprehensive Immunogenetics Solutions for Translational Research

Explore Biomarkers, Assay Development, and HLA Typing Solutions

The Versiti Approach: Excellence from Discovery to Launch

Versiti Clinical Trial Services offers innovative integrated solutions in biomarker assay services. Our ISO 15189- and CLIA-accredited laboratories deliver clinical-grade precision and regulatory compliance, bringing patients the world over the breakthroughs they deserve.

Support Along the Biomarker Lifecycle

Biomarker Lifecycle Chart

What is Biomarker Discovery and Assay Development?

Biomarker discovery and assay development allow precise measurement and monitoring of biological responses to therapies during clinical trials. Biomarkers act as indicators of disease presence, progression, or therapeutic response. Custom assays are developed to accurately detect and quantify these biomarkers. Together, they support patient stratification, efficacy evaluation, safety monitoring, and regulatory compliance to accelerate the path from discovery to clinical application.

Custom Assay Design

Purpose-built assays for specific biomarkers or diagnostics, optimized for performance, scalability, and regulatory compliance

Comprehensive Validation

All assays are rigorously validated under CLIA, CAP, and ISO 15189 standards to ensure clinical-grade reliability

End-to-End Development

Support across the full development lifecycle—from discovery to companion diagnostics and immunological assessments

Advanced Technologies

Assay design, validation, and clinical translation utilizing cutting-edge platforms

 

Client Testimonial: "A Trusted Partner in Achieving Project Success"

“Our experience working with the Versiti team has been remarkable; they truly felt like an extension of our team in executing the study. From highly proactive communication, to creatively navigating a complex and detailed SOW to ensure an efficient sample workflow, all the way through extremely high-quality and timely execution of esoteric testing (over 1,500+ HLA samples in 3 months) for a phase 3 study—they were a trusted partner in achieving project success.”

-An Innovative Global Life Sciences Company

Technical Assay Capabilities

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 Spectrometry (LC-MS)

  • Metabolomics
  • Proteomics
  • Lipidomics

What is HLA Testing and Immunogenetics?

 

What Is HLA Testing and Immunogenetics?

The Human Leukocyte Antigen (HLA) system is a cornerstone of the human immune system. Because it is highly polymorphic and, therefore, presents many challenges and opportunities to therapy developers, expertise in HLA and immunogenetics is critical for success throughout therapeutic development.

HLA testing is necessary for the development of:

  • Cellular and gene-based therapies
  • Vaccine development
  • Immuno-oncology modalities

The Versiti Advantage

Versiti offers high-resolution HLA typing and immunogenetic services critical to cell therapy, regenerative medicine, and clinical trials. With over 30 years of leadership in histocompatibility testing, our understanding of HLA typing extends to the full clinical trial ecosystem.

HLA Typing Services

High-Resolution Typing (NGS)

Allele-level sensitivity for applications requiring minimal ambiguity (e.g., HLA-A*02:01:01)

Intermediate & Low-Resolution Typing

Scalable solutions for varying levels of donor/recipient matching needs

Single Allele Detection

Targeted testing for disease associations and drug hypersensitivity:

  • HLA-B*15:02 – Carbamazepine hypersensitivity
  • HLA-B*57:01 – Abacavir hypersensitivity
  • HLA-B27 – Ankylosing spondylitis
  • HLA-A*29 – Birdshot uveitis
  • HLA-DQ6/DR15 – Narcolepsy
  • HLA-DQA1/DQB1 – Celiac disease
  • HLA Antibody Testing & Virtual Crossmatch
Antibody Detection & Identification

Detect and characterize Class I and II HLA antibodies using PRA and recombinant antigen panels

Virtual Crossmatch

Evaluate donor-specific antibodies (DSA) to assess compatibility with the investigational agent

 
Versiti Clinical Trials HLA Typing Services

Additional Immunogenetic Services

Chimerism Testing

STR/VNTR-based analysis to monitor donor/recipient DNA post-infusion

KIR Genotyping

Identify killer cell immunoglobulin-like receptors (KIR) to support NK cell-based therapies

Why Partner with Versiti?

  • Deep expertise in biomarker and immunogenetic science
  • Proven success across multiple therapeutic areas
  • Seamless transition from research to clinical application
  • Fully accredited labs (CLIA, CAP, ISO 15189)
  • Collaborative, custom-tailored solutions

Let’s Accelerate Your Research

Versiti is your trusted partner in precision science, from developing a novel diagnostic to launching a clinical trial or advancing cell therapy.

Connect with Our Experts Today
 
Laboratory & Diagnostic Services
Versiti Clinical Trial Services provides central laboratory services, including sample testing, assay development, site management and more.
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Companion Diagnostics
Companion Diagnostic (CDx) assay development to advance therapies with precise, on-time delivery of actionable data for your unique project.
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Quality & Regulatory Services
Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance.
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