NEW YORK – Thermo Fisher Scientific said on Wednesday that its SeCore CDx HLA Sequencing System was granted de novo classification by the US Food and Drug Administration as a companion diagnostic to Immunocore’s Kimmtrak (tebentafusp-tebn) therapy for uveal melanoma.
Kimmtrak is the only T-cell receptor therapy approved by the FDA for metastatic or unresectable uveal melanoma, a rare but deadly eye cancer, and is indicated for adults who are human leukocyte antigen (HLA)-A*02:01 positive. The marketing authorization makes the SeCore CDx HLA Sequencing System the first and so far only commercially available HLA typing companion diagnostic, Thermo Fisher said.
“Clinicians can now use the SeCore CDx HLA Sequencing System to identify individuals who may benefit from this breakthrough immunotherapy,” Nicole Brockway, Thermo Fisher’s president of transplant diagnostics, said in a statement. “We look forward to continuing to partner with leading-edge companies to develop and commercialize immunotherapies that address unmet needs in a variety of disease areas.”