

Pulmotype™ is a qualitative immunohistochemistry (IHC) assay consisting of a panel of five IHC monoclonal antibody reagents and an associated algorithm to be used on formalin-fixed, paraffin embedded lung cancer core biopsies. It is indicated for use as an aid in the diagnosis of squamous versus adenocarcinoma morphology for non-small cell lung cancer (NSCLC) patients prior to surgery or staging. Further validation is being performed to assess an indication for use as an aid in the diagnosis of squamous versus adenocarcinoma morphology for selection of patients to receive erlotinib (Tarceva®) or exclusion of patients to receive bevacizumab (Avastin®).
The five Pulmotype biomarkers that make up the test are listed below along with a brief description of their potential function in the cell:

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CK5/6 recognizes cytokeratin 5 and 6 and is strongly differentially expressed in lung carcinoma subtypes. |

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MUC1 is a member of the mucin family; alleles of the MUC1 gene are associated with different lung carcinoma subtypes. |

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TRIM29 contains multiple zinc finger motifs and a leucine zipper motif and thus may act as a transcriptional regulatory factor. |

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CEACAM5 is normally expressed in embryonic tissue and is aberrantly expressed in some cancers.
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SLC7A5 is involved in nutrient transport. Over-expression of SLC7A5 could help sustain the high growth rate of cancer cells by increasing a cell’s ability to consume nutrients.
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