Uveal melanoma HLA typing test receives de novo classification
Source: Healio, December 2022
The FDA granted de novo classification to the SeCore CDx HLA Sequencing System for use as a companion diagnostic with Kimmtrak for metastatic or unresectable uveal melanoma, according to a Thermo Fisher Scientific press release.
High-resolution human leukocyte antigen (HLA) typing is important for identifying HLA-A*02:01-positive patients, and the approval will make the SeCore system the first HLA typing companion diagnostic commercially available.
Kimmtrak (tebentafusp, Immunocore) is currently the only FDA-approved T-cell receptor therapy for metastatic or unresectable uveal melanoma. The SeCore system has previously been used to identify HLA-A*02:01-positive patients for enrollment in Kimmtrak clinical trials, according to the release.