Article ; Online: Evaluation of a gene expression microarray-based assay to determine tissue type of origin on a diverse set of 49 malignancies.
The American journal of surgical pathology
2011 Volume 35, Issue 7, Page(s) 1030–1037
Abstract: ... the performance of TOO-FRZ on a diverse collection of malignancies. We collected a diverse set of 49 malignancies ... from a tissue type not included in the TOO-FRZ assay (n=3), and malignancies of unknown primary (n=7). We found ... The Tissue of Origin Frozen (TOO-FRZ) assay from Pathwork Diagnostics has been cleared ...
| Abstract | The Tissue of Origin Frozen (TOO-FRZ) assay from Pathwork Diagnostics has been cleared by the Food and Drug Administration as a diagnostic study for malignancies of unknown primary. The goal of this study was to evaluate the performance of TOO-FRZ on a diverse collection of malignancies. We collected a diverse set of 49 malignancies. We classified each case into 1 of 4 groups: common morphology from a tissue type included in the TOO-FRZ assay (n=29), uncommon morphology from a tissue type included in the TOO-FRZ assay (n=10), tumor from a tissue type not included in the TOO-FRZ assay (n=3), and malignancies of unknown primary (n=7). We found strong diagnostic performance for common morphologies from tissue types on the TOO-FRZ [overall accuracy=26 of 29 (90%, 95% CI, 73% to 97%)], with perfect performance in all tissue types except gastric (0 of 2) and pancreatic (1 of 2) tissues. There was a significant decline in performance for uncommon morphologies from tissue types included in the TOO-FRZ assay [6 of 10 (60%) cases with an indeterminate result, 1 of 10 (10%) cases with an incorrect prediction, and 3 of 10 (30%) with a correct prediction] and for tumors from tissue types not included in the assay (incorrect prediction in 2 of 3 cases). For the 7 malignancies of unknown primary in our study set, the TOO-FRZ provided a likely clinically useful result in only 2 of 7 cases. These results provide an insight into the strengths and limitations of this molecular assay for the surgical pathologist, and our findings suggest future directions for research in this area. |
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| MeSH term(s) | Algorithms ; Female ; Frozen Sections ; Gene Expression Profiling ; Gene Expression Regulation, Neoplastic ; Humans ; Male ; Neoplasms/diagnosis ; Neoplasms/genetics ; Neoplasms/metabolism ; Neoplasms, Unknown Primary/diagnosis ; Neoplasms, Unknown Primary/genetics ; Neoplasms, Unknown Primary/metabolism ; Oligonucleotide Array Sequence Analysis/methods ; Predictive Value of Tests ; Reproducibility of Results | |||||
| Language | English | |||||
| Publishing date | 2011-05-22 | |||||
| Publishing country | United States | |||||
| Document type | Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't | |||||
| ZDB-ID | 752964-8 | |||||
| ISSN | 1532-0979 ; 0147-5185 | |||||
| ISSN (online) | 1532-0979 | |||||
| ISSN | 0147-5185 | |||||
| DOI | 10.1097/PAS.0b013e3182178b59 | |||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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