NEW YORK – Agilent Technologies said Friday that it has received US Food and Drug Administration approval for an immunohistochemistry assay that is used to help guide the treatment of patients who have the rare soft tissue cancer synovial sarcoma.
The Santa Clara, California-based firm's MAGE-A4 IHC 1F9 PharmDx assay is used to identify which patients are eligible for treatment with Adaptimmune Therapeutics' Tecelra (afamitresgene autoleucel), a newly approved engineered cell therapy. The test is used to detect in formalin-fixed paraffin-embedded synovial sarcoma tissue the expression of MAGE-A4, or melanoma-associated antigen A4, a cancer-testis antigen that is overexpressed in certain cancers.
Lou Welebob, VP and general manager of Agilent's Pathology Division, said in a statement that the approval will expand treatment options as well as demonstrates the company's "pioneering role in shaping companion diagnostics for groundbreaking cancer therapies."
Adaptimmune said in a separate announcement on Friday that it had received accelerated FDA approval of Tecelra as the first engineered cell therapy for a solid tumor cancer in the US and the first new therapy for synovial sarcoma in more than 10 years. Tecelra is used for the treatment of adult patients who have unresectable or metastatic synovial sarcoma, have received prior chemotherapy, have tumors that express the MAGE-A4 antigen as identified by a companion diagnostic, and are positive for the HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 antigens.
Adaptimmune noted in its announcement that in addition to its deal with Agilent, it also has partnered with Thermo Fisher Scientific to expand the labeling of Thermo Fisher's companion diagnostic SeCore CDx HLA-A Locus Sequencing System to allow its use to identify synovial sarcoma patients who are positive for HLA-A*02:01, -A*02:02, -A*02:03, and -A*02:06 and help to guide treatment with Tecelra.