PD-L1 IHC 22C3

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PD-L1 IHC 22C3 is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein. PD-L1 IHC 22C3 is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab).

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EGFR Mutation Analysis (LDT)

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The presence of any of 59 possible EGFR mutations in exons 18-21 (including the T790M mutation in exon 20) is identified by real-time polymerase chain reaction.

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Lung Targeted Profile

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There are several key genes recurrently mutated in lung cancer. Genomic DNA is isolated from formalin fixed paraffin embedded tissue and the DNA sequence of targeted regions of the ALK, BRAF, CD274, EGFR, ERBB2, KRAS, and MET genes is determined using next-generation sequencing (NGS) technology.

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BRAF V600E Mutation Analysis for non-Melanoma (LDT)

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The cobas 4800 BRAF V600 Mutation Test is a real-time PCR assay intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin fixed, paraffin-embedded human tumor tissue.

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ROS1 Rearrangement

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Rearrangement of the ROS1 gene is detected by fluorescence in situ hybridization (FISH).

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RET Rearrangement

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Rearrangement of the RET gene is detected by fluorescence in situ hybridization (FISH).

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MET Amplification

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Amplification of the MET gene is detected by fluorescence in situ hybridization (FISH).

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FGFR1 Amplification

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Amplification of the ibroblast growth factor receptor 1 (FGFR1) gene is detected by fluorescence in situ hybridization (FISH).

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ALK Rearrangement

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The FDA-approved Vysis® ALK Break Apart FISH Probe Kit detects rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens.

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