Clinical Trial HLA Typing Services

High-throughput, accurate, and regulatory-compliant clinical human leukocyte antigen (HLA) testing for both prospective and retrospective clinical trial applications in oncology, immunology, neurology, and other therapeutic areas.

Reduce Time-to-Results with
Discovery's Clinical HLA Typing Services

Comprehensive clinical genotyping services provided with market-leading speed enable researchers and clinicians to make decisions faster. Get prospective IVDR-compliant Sanger sequencing results in just 3 days to optimize patient selection and management for clinical trials or get extensive retrospective next-generation sequencing (NGS) data within 2 weeks to access critical data for biomedical research.

Expertise

Discovery has supported over 2000 clinical trial programs across many therapeutic areas for leading biotech and pharma clients. As a single provider with unified reporting and a single chain of custody, our CLIA-certified, CAP-accredited service labs execute IVDR-compliant genotype testing, supporting both prospective and retrospective clinical trials.

Technology

Thermo Fisher 3500 Dx Genetic Analyzer with 3500 Dx Series Data Collection Software is an advanced platform designed for high-throughput clinical diagnostics.

Compliance & Quality

Specialty testing in CLIA-certified, CAP accredited, and GCLP compliant service laboratories to support concurrent clinical trials and regulatory submissions.

IVDR-compliant services with Health Institution status of Discovery’s laboratory in Germany confirmed by German Regional Council. .

Global Harmonization

Global standardization and harmonization of assays including global clinical trial testing and our post-approval training and services.

Access to Clinical Specimens

Access to the world’s largest commercial biorepository to build optimal study cohorts.

Rapid biomarker Testing

Combine HLA genotype testing with Discovery's other multi-omic services, such as IHC, ISH (Fish, dual ISH, RNA Scope), RT-qPCR, and mutation testing, to achieve a multidimensional approach to biomarker assessment in prospective and retrospective clinical trials – all under one roof. As a single provider with unified reporting and a single chain of custody, we help streamline clinical trial workflows and enhance data integrity.

Clinical Trial HLA Typing Technologies

  • IVDR-compliant, with SeCoreTM Sequencing Kit and uTYPETM HLA Sequence Analysis Software from One Lambda, capable of delivering high throughput prospective Sanger sequencing data in just three days.
  • Preserve precious blood samples with a sample input of only 75-150 ng of genomic DNA.
  • Streamline data collection for prospective clinical testing with data specific and limited to clinical trial via Sanger sequencing.
  • Simple workflow with automated operations

High-throughput NGS is available as orthogonal method for HLA-A testing to resolve potential ambiguities of genotyping results with NGSgo® MX6-1 Assay and NGSengine® software from GenDx.  Discovery’s advanced NGS technologies, including Illumina NovaSeq X Plus systems, optimized protocols, automated workflows, strict regulatory compliance, and industry-leading expertise, deliver reliable data at any scale.

ThermoFisher 3500 Dx Genetic Analyzer

Illumina MiSeq System

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