Organ transplant milestone as Thermo Fisher launches robust diagnostic technologies

USA – Thermo Fisher Scientific has announced two new additions to its transplant diagnostics portfolio at the annual meeting for the American Society for Histocompatibility and Immunogenetics (ASHI).

These new products will allow transplant laboratories to better characterize samples while also increasing speed and confidence.

The transplant diagnostics market comprises of the sale of transplant diagnostics test products as well as related services. Transplant diagnostics are tests performed prior to the relocation or transplantation of a donor organ to a recipient patient.

Human leukocyte antigen (HLA) diagnostic testing, PCR-based assay, serological test, and mixed lymphocyte culture (MLC) assay are some of the transplant diagnostics tests available.

Candidates for organ transplantation are routinely tested for the presence of antibodies directed against non-self HLA, and the results are used to match them with compatible donors. Donor-specific HLA antibodies are usually enough to rule out transplantation.

A new serum treatment reagent is being developed to address nonspecific antibody reactivity in certain samples. This novel solution was created in collaboration with Terasaki Innovation Center scientists and is expected to be available later this year.

Highlighting the benefit of this new serum treatment reagent, Sam Ho, director of the Histocompatibility and Infectious Disease Testing Laboratory at Gift of Hope Organ & Tissue Donor Network said, “Some samples demonstrate nonspecific antibody reactivity.”

“This new reagent may enable us to identify specific reactivity with greater clarity, improving our ability to determine immunologic risk at all stages of the transplant patient journey,” he added.

Besides Thermo Fisher Scientific, other major players in the transplant diagnostics market include Illumina, Inc., F. Hoffmann La-Roche AG., Abbott Laboratories, Inc. and Qiagen NV.

A rapid next-generation sequencing (NGS) assay that will provide high-resolution data in five hours was also announced at ASHI, significantly reducing the time it currently takes to characterize the HLA genes in solid organs from deceased donors using currently available NGS.

This new assay, designed for use on the Oxford Nanopore platform, will improve time-to-results and decision-making confidence. The assay is one of several significant investments made by Thermo Fisher in NGS, including its own portfolio of Ion Torrent NGS solutions for a variety of applications.

“The provision of deceased donor HLA typing at the allelic level within a clinically relevant timeframe will have a tremendous impact on the transplant outcomes of some of the most immunologically challenging patients awaiting a donated organ,” said Nicole Brockway, president, transplant diagnostics at Thermo Fisher.

Authorities such as the US Food and Drug Administration regulate the transplant diagnostics market. Companies in the transplant diagnostics market, are obliged to follow the Good Laboratories Practices (GLP) Part 58 as stipulated by the FDA Title 2.1.

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