FDA Grants Thermo Fisher Scientific SeCore HLA Typing Kit 510(k) Clearance for Use as Companion Diagnostic with a T-Cell Receptor Therapy for Synovial Sarcoma

WEST HILLS, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its SeCore™ CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA^® (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults.^1,2

Cancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific human leukocyte antigen (HLA) proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR T-cell therapies like TECELRA.

While the origins of HLA typing are most closely associated with transplant diagnostics, a critical component of matching patients and donors to reduce the risk of immune-mediated rejection, HLA proteins have wide-reaching effects on the immune system and may play a role in many immune-mediated conditions. Thermo Fisher’s Transplant Diagnostics business is committed to leveraging its history of innovation in immunology to help customers develop novel treatments that enable better patient outcomes, regardless of therapeutic area.

“We are thrilled to expand the labeling of our companion diagnostic SeCore CDx HLA A Sequencing System to include TECELRA and to support clinicians in identifying which patients may benefit from this first-of-its-kind treatment,” says Tina Liedtky, president, Transplant Diagnostics, Thermo Fisher Scientific. “Our knowledge of the human immune system and how it might impact treatment options across the healthcare continuum continues to evolve. We look forward to ongoing opportunities to collaborate with innovative companies like Adaptimmune to expand patient access to breakthrough treatments that improve quality of life.”

For more information about the SeCore CDx HLA Sequencing System, visit www.thermofisher.com/us/en/home/clinical/transplant-solutions/pre-transplant-testing/hla-typing.html

For full TECELRA Prescribing Information, including Important Safety Information, visit www.tecelra.com.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $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.

¹Aytekin MN, et al. “Epidemiology, incidence, and survival of synovial sarcoma subtypes: SEER database analysis.” J Orthop Surg. 2020;28(2):1-12. doi: 10.1177/2309499020936009.
2 “Synovial Sarcoma.” National Cancer Institute. https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/synovial-sarcoma. Accessed July 24, 2024.