Thermo Fisher's human leukocyte antigen (HLA) typing kit, the SeCore CDx HLA A Sequencing System, has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic (CDx) with Adaptimmune's T-cell receptor therapy Tecelra (afamitresgene autoleucel) for synovial sarcoma.
Tecelra was approved last week 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 tumors express the MAGE-A4 antigen, as determined by FDA-approved CDxs, such as the SeCore CDx HLA A Sequencing System. Synovial sarcoma is a rare soft-tissue cancer that most commonly affects young adults.
While HLA typing is more commonly associated with transplant diagnostics, T-cell receptors interact with certain HLA proteins to activate an immune response. Thus, HLA typing is a critical step in identifying patients who are most likely to benefit from T-cell receptor therapies such as Tecelra.
"We are thrilled to expand the labeling of our companion diagnostic SeCore CDx HLA A Sequencing System to include Tecelra and to support clinicians in identifying which patients may benefit from this first-of-its-kind treatment," Tina Liedtky, president of transplant diagnostics at Thermo Fisher, said.
