Pulmotype is a five antibody immunohistochemistry (IHC) test developed by Applied Genomics that can be used to aid in the histological distinction between adenocarcinoma and squamous cell carcinoma in non-small cell lung cancer (NSCLC) tumor specimens.
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How can Pulmotype help patient treatment? |
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Histologic diagnosis of NSCLC has become important for appropriate therapy selection in advanced NSCLC. Both Avastin® (bevacizumab) and Alimta® (pemexetred) are FDA approved for non-squamous histotypes because of serious side effects associated with squamous cell carcinoma patients.
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What specimens are appropriate for Pulmotype? |
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The ease of diagnosis with Pulmotype makes this test a cost-effective and efficient part of any classification procedure. It is especially useful for any specimen where morphologic assessment is not certain especially small specimens (e.g. needle biopsies) and poorly differentiated surgical specimens.
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How does Pulmotype compare to TTF-1 and TP63? |
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Pulmotype and TTF-1/TP63 are essentially equally precise in determining differentiation type and agree in histotype assignment for almost all cases where an IHC-based diagnosis is made. However, Pulmotype is able to assign a class in a much greater percentage of cases (higher sensitivity with equivalent specificity).
Thus many more patients will be given a diagnosis that aids in therapy selection when Pulmotype is used as opposed to TTF-1/TP63.
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How was Pulmotype developed and validated? |
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Pulmotype was derived by translating insights from genomic analysis of NSCLC into an IHC-based assay. Pulmotype antibodies were selected from hundreds of other antibodies all screened to give the most precise histologic diagnosis possible. Pulmotype was validated and compared to TTF-1/TP63 on three independent cohorts comprising over eleven hundred specimens by comparing histotype assignment by Pulmotype versus ‘gold standard’ morphological assessment on surgical specimens in AGI's published study in Modern Pathology.
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How should I interpret a Pulmotype diagnosis on a case that appears to be poorly differentiated or large cell carcinoma? |
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In AGI's published study in Modern Pathology, Pulmotype assigned a histologic diagnosis of either adenocarcinoma or squamous cell carcinoma to a significant fraction of cases where a pathologist assigned either a large cell diagnosis or unclassifiable diagnosis (poorly differentiated). Of note, the assigned histotype diagnoses of both Pulmotype and TTF-1/TP63, two distinctly independent tests, agreed with each other in the vast majority of these cases. This suggests that the use of Pulmotype may be able to reliably
assign an adenocarcinoma or squamous cell carcinoma histotype even when the morphological assessment is ambiguous. However, there is currently no clinical data that assesses side effects or response to targeted therapies in cases re-assigned by IHC phenotype.
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Is Pulmotype FDA approved? |
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Pulmotype is being commercialized as a “home brew” test performed in a CLIA-regulated lab. It is to be used an as aid for histologic classification by a pathologist.
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What are the proteins that are measured in the Pulmotype
test and how is a diagnosis given? |
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Pulmotype measures three proteins associated with squamous differentiation (CK 5/6, SLC7A5 and TRIM29) and two proteins associated with adenocarcinoma differentiation (MUC1 and CEACAM5). Subjective interpretation of these stains (stain present or absent) is performed by the referring pathologist and these scores are entered into a simple weighted algorithm which diagnoses the case as consistent with adenocarcinoma, squamous differentiation or unclassifiable. A simple to use Scoring and Interpretation Manual is provided to the ordering pathologist as an aid.
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