FDA Grants De Novo Classification to HLA Typing Test for Use as a Companion Diagnostic with a T Cell Receptor Therapy for Metastatic or Unresectable Uveal Melanoma

December 7, 2022 |

2 min read

Thermo Fisher Scientific Inc. today announced that its SeCore CDx HLA Sequencing System was granted De Novo Classification by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with KIMMTRAK ®.

The SeCore CDx HLA Sequencing System is the first HLA typing test to receive marketing authorization by the FDA for use as a companion diagnostic

WEST HILLS, Calif.--(BUSINESS WIRE)-- Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its SeCore CDx HLA Sequencing System was granted De Novo Classification by the United States 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,” said 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, the first and only 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. For more information about HLA typing, visit www.thermofisher.com/onelambda.

Reference:

Nathan P, et.al. 2021. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 23;385(13):1196-1206.

* For full KIMMTRAK Prescribing Information, including Important Safety Information, visit www.kimmtrakhcp.com.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.