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The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
Almac said that the assay will be used in a clinical study of repotrectinib (TPX-0005), an investigational, next-generation tyrosine kinase inhibitor.
Sophia's STS molecular diagnostic application runs on top of the Sophia AI platform to detect and characterize genomic alterations in solid tumors.
The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.
The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.