Abstract: Disclosed herein are methods for detecting the presence and/or amount of HER2 protein, HER2 nucleic acid (for example, HER2 genomic DNA), ER protein, and Chromosome 17 centromere DNA in a single sample. Samples stained for HER2 protein, HER2 DNA, ER protein, and Chromosome 17 DNA allow for the identification of various types of cancer cells, for example HER2 protein positive/ER protein positive/HER2 gene positive cells, HER2 protein positive/ER protein negative/HER2 gene positive cells, HER2 protein negative/ER protein positive/HER2 gene positive cells, and HER2 protein negative/ER protein negative/HER2 gene positive cells.

Abstract: Multiplex assays for improved scoring of tumor tissues stained with PD-L1 featuring PD-L1 staining in a first color plus staining of one or more differentiating markers, such as a marker specific for tumor cells and a marker specific for immune cells, are disclosed. The differentiation between the tumor cells and immune cells may improve the ease of scoring, the accuracy and speed of scoring, and the reproducibility of scoring of PD-L1 positive samples for therapy purposes.

Abstract: Disclosed herein are methods for predicting the response to a HER2-directed therapy and for scoring a breast cancer tumor sample. In some embodiments, the methods include contacting the sample with an antibody that specifically binds HER2 protein and detecting presence and/or amount of HER2 protein and contacting the sample with a nucleic acid probe that specifically binds to HER2 genomic DNA and detecting presence and/or amount of HER2 genomic DNA (such as HER2 gene copy number). In some embodiments, the methods further include detection of a centromere nucleic acid (such as chromosome 17 centromere DNA) and contacting the sample with an antibody that specifically binds ER protein and detecting presence and/or amount of ER protein in the same sample.

Abstract: Disclosed herein are methods for detecting the presence and/or amount of HER2 protein, HER2 nucleic acid (for example, HER2 genomic DNA), ER protein, and Chromosome 17 centromere DNA in a single sample. Samples stained for HER2 protein, HER2 DNA, ER protein, and Chromosome 17 DNA allow for the identification of various types of cancer cells, for example HER2 protein positive/ER protein positive/HER2 gene positive cells, HER2 protein positive/ER protein negative/HER2 gene positive cells, HER2 protein negative/ER protein positive/HER2 gene positive cells, and HER2 protein negative/ER protein negative/HER2 gene positive cells.

Abstract: Multiplex assays for improved scoring of tumor tissues stained with PD-L1 featuring PD-L1 staining in a first color plus staining of one or more differentiating markers, such as a marker specific for tumor cells and a marker specific for immune cells, are disclosed. The differentiation between the tumor cells and immune cells may improve the ease of scoring, the accuracy and speed of scoring, and the reproducibility of scoring of PD-L1 positive samples for therapy purposes.