Uveal melanoma HLA typing test receives de novo classification
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The FDA granted de novo classification to the SeCore CDx HLA Sequencing System for use as a companion diagnostic with Kimmtrak for metastatic or unresectable uveal melanoma, according to a Thermo Fisher Scientific press release.
High-resolution human leukocyte antigen (HLA) typing is important for identifying HLA-A*02:01-positive patients, and the approval will make the SeCore system the first HLA typing companion diagnostic commercially available.
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Kimmtrak (tebentafusp, Immunocore) is currently the only FDA-approved T-cell receptor therapy for metastatic or unresectable uveal melanoma. The SeCore system has previously been used to identify HLA-A*02:01-positive patients for enrollment in Kimmtrak clinical trials, according to the release.
“Clinicians can now use the SeCore CDx HLA Sequencing System to identify individuals who may benefit from this breakthrough immunotherapy,” Nicole Brockway, president of transplant diagnostics at Thermo Fisher Scientific, said in the release. “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.”
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