HLA Center of Excellence

Translation Across the Therapeutic Development Product Lifecycle

The Role of HLA in Therapy Development

The human leukocyte antigen (HLA) system is a cornerstone of the human immune system. Because it is highly polymorphic, it can present significant challenges and opportunities to therapy developers. A high degree of expertise in HLA and immunogenetics is critical for success and agility on the path to therapeutic development.

HLA Testing Is Essential for Developing:

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

Versiti Leads the Way in HLA for Clinical Development

Versiti Clinical Trials, the premier name in clinical study support, is proud to offer leading expertise in HLA testing for clinical studies and cellular therapy development. This deep expertise is paired with broad experience across essential clinical trial management functions, including:

  • Batch testing
  • Data transfers
  • Project management
  • Sample logistics
  • Navigating regulatory hurdles
  • Clinical validations
  • Evaluation and positioning for market adoption
  • And much more

The Versiti Advantage

Therapeutic Area Expertise & Consultation Infographic
Industry Leading Turnaround Times Infographic
Scalability; From Single Piece Flow to Batch Testing Infographic
Large Volume Handling & Logistics Infographic
Data Transfers Infographic

We apply our extensive clinical expertise and comprehensive understanding of the clinical trial ecosystem throughout every stage of your trial, from protocol design all the way through commercialization.

Consult with Versiti HLA Experts Today

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

HLA Typing Services

At the HLA Center for Excellence, Versiti offers such cutting-edge HLA typing services as:

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
  • 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

Detection and characterization of Class I and II HLA antibodies using PRA and recombinant antigen panels

Virtual Crossmatch

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

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New Capabilities Now Available: HLA Typings by Next Generation Sequencing (NGS)

Verisiti is proud to offer new and enhanced NGS HLA typing assays showcasing unparalleled precision. These high-resolution panels deliver comprehensive data on both classical and non-classical HLA loci. Coverage of non-classical loci (HLA-E, -F, -G, -H, MICA, MICB). is essential for immune regulation research in NK cell therapies, immuno-oncology, and virology.

Discover new flexible panel configurations guided by clinical diagnostic experts and tailored to meet the unique demands of your study.

Additional Immunogenetic Services

Versiti is here to support your clinical trial needs with such other immunogenetic services as:

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.

History of Innovation in HLA

Versiti awarded NHLBI grant to study Class I HLA antigens
1970s
Facilities first successful treatment of aplastic anemia with a bone marrow transplant from unrelated donor
1982
Identifies HLA markers important to matching bone marrow transplant donors and recipients
1990s
Presents first data correlating improved transplant outcomes with HLA typing by NGS
2018
Versiti types over 7,000 donors for HLA antigens and collaborates with NMDP to establish national registry of bone marrow donors
1981
Publishes first report of HLA-DQ antigen and serologic reactivity
1982
First lab to offer DNA-based typing tests for HLA Class II loci
1990s
Develops HLA Loss of Heterozygosity assay to detect and characterize post-transplant relapse
2021

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

Meet Versiti’s Histocompatibility Leadership

 
Jennifer J. Schiller, PhD, F(ACHI)

Dr. Schiller is the senior director of histocompatibility and immunogenetics at Versiti Diagnostic Laboratories.

 
Matthew Anderson, MD, PhD

Dr. Anderson leads Versiti's Medical Sciences Institute (MSI), providing strategic leadership and guiding innovative research and clinical programs.

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