FDA Approves Thermo Fisher HLA Typing Test as CDx for Immunocore Uveal Melanoma Therapy
The marketing authorization makes Thermo Fisher’s SeCore CDx HLA Sequencing System the first and so far only commercially available HLA typing companion diagnostic.
Immucor, Pirche Partner to Embed Epitope Matching Prediction Pipeline into Transplant Dx Software
An unspecified investment will give Immucor exclusive access to PIRCHE scores and embedded visualizations for HLA antibody analysis.
GenDx Licenses Proximity Ligation Assay From Dovetail Genomics for Use in Transplant Diagnostics
GenDx will combine the assay technology with its next-generation sequencing-based HLA typing to develop new products, including for haplotyping of HLA genes.
GenDx Gets IVDR Certificate for HLA Typing Products
The regulation establishes, among other things, increased quality management and continuous evaluation for in vitro diagnostics, the company said.
GenDx Gets Health Canada Approval for HLA Genotyping Test
Genotyping data from the NGSgo-MX11-3 test can be used to help match patients and donors for stem cell transplantation.