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ALK Fusion – FISH is a fluorescence in situ hybridization (FISH) test designed to detect ALK gene rearrangements in tumor samples, primarily for non-small cell lung cancer (NSCLC) patients. Key features include high sensitivity and specificity, FDA approval for clinical diagnostics, and direct visualization of ALK gene fusions at the cellular level.
The PD-L1 (22C3) Dako CPS (IHC) test is an immunohistochemistry (IHC) assay designed to assess PD-L1 expression in tumor and immune cells using the Combined Positive Score (CPS). It is FDA-approved as a companion diagnostic for multiple cancer therapies, ensuring precise patient selection for immune checkpoint inhibitors. The test utilizes the 22C3 monoclonal antibody, providing high sensitivity and specificity in detecting PD-L1 expression. Its standardized scoring system (CPS) enhances reproducibility and clinical decision-making, making it a trusted tool for oncologists. The Dako platform ensures consistent, high-quality staining, supporting accurate and reliable results for personalized cancer treatment.