HLA Tissue Typing Service | ProImmune

HLA Tissue Typing Service from ProImmune

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typeHLA - HLA Typing Simplified

Over 99% of our genes are the same

HLA type is a crucial part of the difference

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HLA Tissue Typing Service

  • Straightforward, dependable core facility HLA tissue typing service

  • Using state of the art genotyping technologies as used in HLA typing for organ transplantation

  • We work with genomic DNA, Saliva, Whole Blood, or Cryopreserved cells

  • Detailed results typically sent in 3 weeks

 

typeHLA Tissue Typing Service Overview

 

Typing technology options

 Third Generation Sequencing (TGS)

PCR-based

HLA Class I loci available

A, B and C

(whole Class I panel reported)

A, B, C

(can be ordered individually)

HLA Class II loci available

DRB1, DPB1 and DQB1

(whole Class II panel reported)

DRB1, DRB3,4,5, DPA1, DPB1, DQA1, DQB1

(can be ordered individually)

Resolution of typing data

 

Fully resolved 4 digit (allelic level) typing with no degeneracy in most cases

 

 

4 digit (allelic level) typing but with some degeneracy

 

Features / Restrictions

Only available for ordering whole Class I panel (3 loci) or whole Class II panel (3 loci) or whole Class I and Class II panel (6 loci)

 

Can be ordered for each locus individually

Turnaround time (approximate)

3 weeks

Sample formats accepted

gDNA, Cryopreserved PBMCs/other Cells, Blood, Saliva

Report format

Electronic format (PDF, XLS) via secure webserver

 

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typeHLA Tissue Typing Service in Detail

Option 1: TGS (Third Generation Sequencing), Class I and Class II

Allelic-level typing of full-length HLA genes ensures 4-digit typing is obtained, with no requirement for additional testing to resolve ambiguities. Where prior art PCR-based typing may return a type of: HLA-A*23:01/03/05/06, TGS would determine the exact allele present - e.g. HLA-A*23:01. 

TGS HLA typing allows you to determine HLA types precisely, quickly, and in a single analysis, saving time and money, and removing doubt from HLA analysis.

 

Option 2: PCR-based Typing, Class I and Class II

Typing is carried out using a range of techniques, selected based on the individual sample and loci being typed. Major allele groups are resolved  to 4 digits, with some degeneracy in allele resolution, e.g. HLA-A*23:01/03/05/06.

In PCR-SSO the genomic DNA is amplified using PCR, then incubated with a panel of different oligonucleotide probes, which have distinctive reactivities with different HLA-types. PCR-SSP uses specific primers designed such that a PCR product is either generated or not generated, based on specific polymorphisms in the HLA gene. SBT (Sequence-based typing) uses dye terminator sequencing of key regions of the HLA genes.

 

Sample Types and Order Handling

We accept genomic DNA, saliva samples, fresh whole blood or frozen cells, and will provide you with details of how to ship each of these to us. There is an order handling charge for samples sent as saliva, whole blood or frozen cells due to the additional processing needed for these sample types.

We offer a worldwide service, available for one sample or hundreds - our high throughput service enables us to process tens to hundreds of samples at a time. You can confidently send your samples from any location worldwide using our experience in shipping globally.

 

Sample Requirements and Sample Quality

We have the following requirements for samples:

  • gDNA: Minimum 15 ng/μl concentration and minimum 150 μl. For TGS, quality must be sufficient to allow production of amplicons of 3.5 kb for Class I and 5.5 kb for Class II.

  • Blood: Fresh or frozen, 4 ml drawn into EDTA.

  • Cryopreserved cells: 1 vial of 1-2 million cells.

  • Saliva: collected in Oragene-ONE (Worldwide) or Oragene-DISCOVER (USA) kit.

Note that samples provided as whole blood/PBMC/saliva are subject to an Order Handling Fee for each shipment. Samples supplied as gDNA will NOT be subjected to Order Handling Fee.

 

Why Should You Outsource HLA Tissue Typing to ProImmune?

  • Uses state of the art genotyping technologies as used in HLA typing for clinical applications;

  • Our service covers study planning, sample shipping, data reporting and interpretation as well as an appropriate contractual relationship;
  • Eliminates issues that can arise from informal relationships with a local typing lab;

  • Professional, reliable HLA Tissue Typing service;
  • In advance of starting functional cellular assays such as ELISpot, or carrying out flow cytometry testing with HLA multimers, tissue typing is usually required for interpreting results successfully;

  • If you are carrying out a clinical trial, establishing the tissue type of your donor samples is an important step. Many diseases and the immunological response to them are associated with specific HLA types. Correlating your trial results with the sample tissue type may give you critical additional information that could make a difference to the interpretation of the results;

  • FDA Guidance on Immunogenicity Assessment for Therapeutic Protein Products (August 2014) recommends as follows:  "Evaluation of genetic factors that may modulate the immune response to a  therapeutic protein product is recommended. For example, the subset of patients that generate neutralizing antibodies to IFN-beta products are more likely to possess distinct HLA haplotypes (Hoffmann, et al. (2008) Am J Hum Genet, 83(2):219-27). Thus knowledge of the heightened susceptibility of patients with such HLA haplotypes may allow for measures to prevent such responses or to pursue other treatment options."

  • If your time and resources are limited, and deadlines are imminent, our typeHLA Service provides just the help you need.

 

How it can make all the difference

Many clinical or other statistical studies of human cohorts fail their primary endpoints because they do not reach statistical significance on their core hypothesis. Studies are usually designed to cover a diverse group of individuals with a broad distribution of HLA tissue types. However, there is the possibility that when the study is reanalyzed on the basis of detailed HLA typing data, that statistically-significant trends become visible. Such analysis could make all the difference in recovering the success of a study for at least a sub-population in the cohort or for formulating important new hypotheses to be investigated.

The driving force in the development of HLA typing technologies continues to be the field of organ and stem cell transplantation. As a consequence, it is predominantly transplant centers and tissue donor registers that carry out HLA typing routinely. Other scientific research into the HLA linkage of diseases and their treatments has often been carried out in collaboration with such transplantation-focused laboratories. While this can be a practical ad hoc solution it is often also problematic for projects that are not obviously linked to transplantation.

 

HLA-linked diseases and treatments

An individual’s immune response to a foreign agent, such as a vaccine, drug or allergen, can be strongly influenced by their HLA tissue type. In addition there are numerous examples of diseases with known HLA association – for instance, Type 1 Diabetes is associated with HLA-DRB1*04:01, Multiple Sclerosis with HLA-DRB1*15:01 and protection from HIV infection with B*57:01 and B*35:01. It seems absurd, but HLA type is ignored in most clinical trials where the presence of a novel therapeutic is known to influence the immune response.

One of the most relevant examples is recombinant factor VIII, used to treat suffers of hemophilia. There is clear bias towards an anti-drug response in a subset of recipients with common HLA alleles. Efforts are underway to understand this bias fully, and to develop variants of Factor VIII that will be less immunogenic for these individuals.

Autoimmune diseases including Rheumatoid Arthritis (RA) show a strong association with HLA DRB1*01:01 and HLA-DRB1*04:01. A therapeutic target in RA is CD20, and the anti-CD20 antibody Rituxan® (Rituximab), (a chimeric mouse/human monoclonal antibody developed by IDEC Pharmaceuticals) is used in RA treatment. However, Rituxan® contains DR1 and DR4 restricted T cell epitopes, which in the RA population contribute to a high rate of reported immunogenicity.

These examples illustrate the case for understanding your patient population in terms of HLA type, and thus knowing at an early stage how your biologic may perform in different populations. Even if your clinical trial doesn’t result in your therapy going forward, you can maximize the amount of information you gain from the trial by having HLA typing data available.

ProImmune offers HLA Tissue Typing as a service, using Third Generation (TGS) and PCR-based sequencing. Whether you are engaged in a clinical trial or experiments for discovery research, in advance of starting functional cellular assays (such as ELISpot or flow cytometry testing), we highly recommend you find out the tissue type of your donor population, to add value and greater depth to your results.

 

How frequent are different HLA Alleles?

Information about allele frequencies can be found at the following links:

http://www.allelefrequencies.net/default.asp

http://bioinformatics.nmdp.org/

http://www.ebi.ac.uk/imgt/hla/allele.html

For further detailed information on allele frequencies please contact us.

 

HLA Tissue Typing Customer Reviews

Dr. Jennifer Kirchherr at the Duke Human Vaccine Institute in North Carolina, USA affirms the importance of correlating the immune response observed with HLA tissue type for their researchers carrying out clinical studies. In addition she comments, “We looked at a range of companies offering tissue typing, and also at using an on-campus typing facility, and we found that ProImmune were able to offer us the best pricing and turnaround time.” Dr. Kirchherr and her colleagues send regular batches of samples to ProImmune for typing. “They have been wonderfully easy to work with, if we ask anything they get right back to us, and overall it has been a really good experience” she added.

Highlighting the relevance of tissue typing, and the global availability of typeHLA to researchers all over the world, Dr. Navapon Techakriengkrai at Chulalongkorn University, Thailand has also had success with the service. “I outsource my tissue typing to ProImmune because they provide me with the fastest service at the best price. Since the main theme of my research is on T cell immunology, HLA-type is inevitably needed. The customer service from ProImmune is of the best quality. Their tissue typing service allowed me to unambiguously resolve the HLA type of many of my samples.”

 

Image of sample typing report

Discuss your requirements with our customer service team of highly trained immunologists. They will work out the best service for you, and manage the whole process from sample handling to delivery of the final report.

Typically, the results report is available 15 working days following receipt of the samples. Results are delivered in MS Word and Excel formats and are downloaded by the client through our secure server.

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