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SeCore CDx HLA Sequencing System

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. 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.