Home » Thermo Fisher gets FDA De Novo Nod for Rare Eye Cancer Companion Diagnostic
Thermo Fisher gets FDA De Novo Nod for Rare Eye Cancer Companion Diagnostic
The FDA has granted Thermo Fisher Scientific De Novo authorization for its SeCore CDx companion diagnostic for use with Immunocore’s Kimmtrak (tebentafusp-tebn) T cell receptor therapy for metastatic or unresectable uveal melanoma — a rare but deadly cancer of the eye.
The device provides typing of human leukocyte antigen (HLA) proteins, which are the targets for cancer immunotherapies. High-resolution HLA typing is required to identify which patients may benefit from Kimmtrak.
The company says the marketing authorization is the first of its kind, making it the only commercially available HLA typing companion diagnostic.
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