Uveal melanoma is rare but often has a high tendency to metastasize, which results in high mortality. SeCore™ CDx HLA A Locus Sequencing System is the first high-resolution HLA Typing companion diagnostic granted de novo classification by the FDA to aid in the selection of HLA A*02:01-positive patients with uveal melanoma that cannot be removed by surgery or has spread and who may benefit from treatment with KIMMTRAK® (tebentafusp-tebn) when used in accordance with approved therapeutic labeling.
The SeCore CDx HLA Sequencing System can be used to identify and define human leukocyte antigen A-locus (HLA A) alleles using genomic DNA isolated from whole blood samples. The device is intended to be used as a companion diagnostic (CDx) to aid in the selection of HLA A*02:01 patients with unresectable or metastatic uveal melanoma who may benefit from treatment with KIMMTRAK when used in accordance with approved therapeutic labeling.
The SeCore™ Group Specific Sequencing Primer (GSSP) kits target a DNA haplotype to resolve cis/trans (phase) ambiguous allele pairs. Cis/trans ambiguous allele pairs arise from standard Sanger typing. The GSSP binds to only one of the two alleles present in the DNA sample to aid in the determination of the final HLA typing.
The uTYPE™ CDx HLA Sequence Analysis Software processes DNA sample data files generated from the SeCore CDx HLA A Locus Sequencing and SeCore CDx HLA GSSP Kits. The detected HLA alleles are analyzed and assigned by comparison to the IMGT/HLA database.
The uTYPE HLA Sequence Analysis Software combines rapid data analysis with effective results management.
SeCore CDx HLA A Locus
Sanger sequencing assay for identification and definition of HLA-A*02:01 allele(s) and to aid patient selections for the indicated therapies.
SeCore CDx HLA GSSP Kit
Group Specific Sequencing Primers for resolving ambiguous allele combinations from DNA generated by SeCore™ CDx HLA A Locus Sequencing Kit.
Ask About Our HLA Typing Solutions for Companion Diagnostic Development
We have established processes and experience for all aspects of CDx co-development needs that involve coordinated efforts with pharmaceutical partners, contract research organizations (CROs), and regulatory bodies. Capabilities include full HLA typing service laboratories that combine our in-depth scientific knowledge and high-quality regulatory-compliant operations as well as a suite of high-quality products that can accelerate workflow from discovery to clinical trial to regulatory submission.