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TEST:
SeCore CDx HLA Sequencing System

Type:
Laboratory Developed Test
Related tests:
Evidence

News

over1year
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 (Thermo Fisher Scientific Press Release)
"Thermo Fisher Scientific Inc...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 authorization is the first of its kind, making the SeCore CDx HLA Sequencing System the only commercially available HLA typing companion diagnostic....The SeCore CDx HLA Sequencing System was used to identify HLA-A*02:01 positive patients for enrollment in KIMMTRAK clinical trials."
FDA event
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SeCore CDx HLA Sequencing System
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Kimmtrak (tebentafusp-tebn)