FDA Grants Thermo Fisher’s CDx HLA Sequencing System De Novo Classification

Thermo Fisher Scientific’s SeCore CDx HLA Sequencing System was granted De Novo Classification by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic with KIMMTRAK (tebentafusp-tebn), Immunocore’s T cell receptor therapy for HLA-A*02:01-positive adults with metastatic or unresectable uveal melanoma—a rare but deadly cancer of the eye.

The marketing authorization is the first of its kind, making the SeCore CDx HLA Sequencing System the only commercially available HLA typing companion diagnostic.

Cancer immunotherapies, including T cell receptor therapies, have been shown to prolong survival for patients with metastatic or unresectable tumors. T cell receptors interact with certain human leukocyte antigens (HLA) proteins to activate an immune response. Because these proteins are expressed on nearly all nucleated cells in the body, high-resolution HLA typing is a critical step for patient identification.

“Clinicians can now use the SeCore CDx HLA Sequencing System to identify individuals who may benefit from this breakthrough immunotherapy,” says Nicole Brockway, president, transplant diagnostics, Thermo Fisher Scientific. “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.”

KIMMTRAK, an FDA-approved T cell receptor therapy for metastatic or unresectable uveal melanoma, is indicated for adults who are HLA-A*02:01 positive. The SeCore CDx HLA Sequencing System was used to identify HLA-A*02:01 positive patients for enrollment in KIMMTRAK clinical trials [1].

Thermo Fisher’s companion diagnostics are used worldwide to help match patients with targeted therapies.

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