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PD-L1 Biomarker Testing measures the amount of PDL1 on cancer cells. PDL1 is a protein that helps keep immune cells from attacking nonharmful cells in the body. Normally, the immune system fights foreign substances like viruses and bacteria, and not your own healthy cells. Some cancer cells have high amounts of PDL1. This allows the cancer cells to "trick" the immune system, and avoid being attacked as foreign, harmful substances. Current PD-L1 testing is based on immunohistochemistry (IHC) methods. Immunohistochemistry (IHC) is the process whereby antibodies are used to detect proteins (antigens) in cells within a tissue section (for instance liver, pancreas or the heart). PD-L1 is a ligand that binds to PD-1 (programmed cell death-1), expressed on activated T cells, to evade anti-tumor responses. PD-L1 plays a role in inhibiting T cell activation and proliferation and has emerged as an important target in cancer treatment. PD-L1 protein detection by immunohistochemistry (IHC) testing is widely used as a predictive biomarker assay for anti–PD-1/PD-L1 therapies. PIK3CA is a gene that encodes a lipid kinase involved in multiple signaling pathways. These pathways influence cellular functions such as growth, death, and proliferation. PIK3CA mutations activate the PI3K-PTEN-AKT pathway, which is downstream from both the EGFR and the RAS-RAF-MAPK pathways. PIK3CA mutations may cause oncogenic transformation independent of RAS or RAF mutations. PIK3CA mutations occur in about 15% to 30% of breast, endometrial, and colon cancers. They occur less frequently in lung cancer and other types of cancer. Presence of PIK3CA mutations is associated with poor prognosis and lack of response to specific therapies in patients with breast, endometrial, or colon cancer.
