NEW YORK – Thermo Fisher Scientific announced on Tuesday that its HLA typing kit has received 510(k) clearance from the US Food and Drug Administration as a companion diagnostic for Adaptimmune's Tecelra (afamitresgene autoleucel).
The T-cell receptor therapy is intended to treat 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 companion diagnostics, such as Thermo Fisher's SeCore CDx HLA A Sequencing System.
"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 in a statement. "Our knowledge of the human immune system and how it might impact treatment options across the healthcare continuum continues to evolve."
Tecelra was approved by the FDA last week. The SeCore CDx HLA Sequencing System previously received approval from the FDA for use as a companion diagnostic with Immunocore's Kimmtrak (tebentafusp-tebn) for uveal melanoma.
Last week, Agilent announced that its MAGE-A4 IHC 1F9 PharmDx assay has received FDA approval for use as a companion diagnostic with Tecelra.