TEST:

SeCore CDx HLA Sequencing System

"Thermo Fisher Scientific Inc...announced that its SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults."

"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."