Thermo Fisher Scientific has received De Novo Classification from the US Food and Drug Administration (FDA) for its SeCore CDx HLA Sequencing System as a companion diagnostic (CDx) to Immunocore’s Kimmtrak (tebentafusp-tebn) for uveal melanoma.

Kimmtrak is a T-cell receptor therapy for metastatic or unresectable uveal melanoma, which is a rare and deadly eye cancer. It is indicated for the treatment of adults who are human leukocyte antigen (HLA)-A 02:01 positive.

The SeCore CDx HLA Sequencing System is claimed by Thermo Fisher as the first and only commercially available HLA typing companion diagnostic to receive De Novo Classification from the FDA.

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

“We look forward to continuing to partner with leading-edge companies to develop and commercialise immunotherapies that address unmet needs in a variety of disease areas.”

Designed for ease of use and to yield high-quality results, the SeCore kits are said to be high-resolution HLA typing products based on sequence-based typing.

T cell receptors are said to interact with some HLA proteins to trigger an immune response. As these proteins are expressed on almost all nucleated cells in the body, high-resolution HLA typing is a very important step for identification of patients, said Thermo Fisher Scientific.

The SeCore CDx HLA Sequencing System was employed for identifying HLA-A 02:01 positive patients for their enrollment in KIMMTRAK clinical trials.

Recently, Thermo Fisher Scientific launched the TrueMark Infectious Disease Research Panels for the detection and categorisation of different investigating microorganisms. The panel is designed for the quick and accurate detection of 90 different disease pathogens that cause respiratory, urinary, vaginal, gastrointestinal, and sexually transmitted diseases.