FDA Grants De Novo Classification to HLA Typing Test for Use as a Companion Diagnostic with a T Cell Receptor Therapy for Metastatic or Unresectable Uveal Melanoma

WEST HILLS, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its SeCore CDx HLA Sequencing System was granted De Novo Classification by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with KIMMTRAK® (tebentafusp-tebn), Immunocore’s T cell receptor therapy for HLA-A*02:01-positive adults with metastatic or unresectable uveal melanoma—a rare but deadly cancer of the eye. The marketing authoriza