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FDA Grants Thermo Fisher Scientific 510(k) Clearance for SeCore HLA Typing Kit as Companion Diagnostic for T-Cell Receptor Therapy in Synovial Sarcoma

NextEdge Admin

06 Aug 2024

2 min 1 sec

companion diagnostic,synovial sarcoma,Adaptimmune

Thermo Fisher Scientific Inc. announced that its SeCore™ CDx HLA A Sequencing System has received 510(k) clearance from the FDA as a companion diagnostic for TECELRA® (afamitresgene autoleucel), Adaptimmune’s T-cell receptor (TCR) therapy. TECELRA is approved for adults with unresectable or metastatic synovial sarcoma who have previously undergone chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and whose tumors express the MAGE-A4 antigen.

Cancer immunotherapies, including TCR therapies, are critical for treating metastatic or unresectable tumors. TCRs interact with specific human leukocyte antigen (HLA) proteins to trigger immune responses, making high-resolution HLA typing essential for identifying patients likely to benefit from treatments like TECELRA.

Originally linked to transplant diagnostics for reducing immune-mediated rejection, HLA typing has broader implications for the immune system and various conditions. Thermo Fisher’s Transplant Diagnostics leverages its expertise in immunology to innovate and improve patient outcomes across therapeutic areas.

“We are excited to extend the use of our SeCore CDx HLA A Sequencing System to include TECELRA, aiding clinicians in identifying suitable patients for this novel treatment,” said Tina Liedtky, president of Transplant Diagnostics, Thermo Fisher Scientific. “We aim to collaborate with companies like Adaptimmune to enhance patient access to groundbreaking therapies that improve quality of life.”