Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel
Abstract A large proportion of non-small-cell lung cancer (NSCLC) patients harbor clinically actionable genomic alterations, detected in general by broad Next-Generation Sequencing (NGS) panels, since it is the gold standard test and strongly recommended by different societies. However, high failure...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-07-01
|
| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-025-10585-y |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849343857580310528 |
|---|---|
| author | Sandra Satie Koide Breno Jeha Araújo Juliana Doblas Massaro Renata de Godoy e Silva Rodrigo Dienstmann Fernanda Christtanini Koyama Ribeiro |
| author_facet | Sandra Satie Koide Breno Jeha Araújo Juliana Doblas Massaro Renata de Godoy e Silva Rodrigo Dienstmann Fernanda Christtanini Koyama Ribeiro |
| author_sort | Sandra Satie Koide |
| collection | DOAJ |
| description | Abstract A large proportion of non-small-cell lung cancer (NSCLC) patients harbor clinically actionable genomic alterations, detected in general by broad Next-Generation Sequencing (NGS) panels, since it is the gold standard test and strongly recommended by different societies. However, high failure rates due to preanalytical factors and long turnaround times are still hindering rapid treatment decision taking in the real-world setting. The objective of this study was to validate the IntelliPlex Lung Cancer Panel by πCODE Technology for biomarker detection using clinical specimens compared to NGS as the gold standard methodology. A total of fifty-eight (58) Formalin-Fixed Paraffin-Embedded tissue (FFPE) samples from fifty-three (53) patients diagnosed with advanced lung adenocarcinoma and 2 reference controls were used. Overall, the test presented 97,73% sensitivity, 100% specificity and 98,15% accuracy. The IntelliPlex Lung Cancer Panel DNA presented 98% agreement, and the IntelliPlex Lung Cancer Panel RNA presented 100% agreement between the results obtained from the CGP NGS methodology. The IntelliPlex Lung Cancer Panel by πCODE Technology demonstrates high specificity and sensitivity for use in clinical laboratories to routine detection for actionable mutations and fusions in NSCLC tumor samples, with high potential to become an alternative to broad NGS panels according to pre-analytical factors. |
| format | Article |
| id | doaj-art-ece8fed086a3458788892d395e02309c |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-ece8fed086a3458788892d395e02309c2025-08-20T03:42:49ZengNature PortfolioScientific Reports2045-23222025-07-011511710.1038/s41598-025-10585-yValidation of a rapid biomarker assay for lung cancer using the IntelliPlex panelSandra Satie Koide0Breno Jeha Araújo1Juliana Doblas Massaro2Renata de Godoy e Silva3Rodrigo Dienstmann4Fernanda Christtanini Koyama Ribeiro5OC Medicina de Precisão Oncoclínicas&Co São PauloOC Medicina de Precisão Oncoclínicas&Co São PauloOC Medicina de Precisão Oncoclínicas&Co São PauloOC Medicina de Precisão Oncoclínicas&Co São PauloOC Medicina de Precisão Oncoclínicas&Co São PauloOC Medicina de Precisão Oncoclínicas&Co São PauloAbstract A large proportion of non-small-cell lung cancer (NSCLC) patients harbor clinically actionable genomic alterations, detected in general by broad Next-Generation Sequencing (NGS) panels, since it is the gold standard test and strongly recommended by different societies. However, high failure rates due to preanalytical factors and long turnaround times are still hindering rapid treatment decision taking in the real-world setting. The objective of this study was to validate the IntelliPlex Lung Cancer Panel by πCODE Technology for biomarker detection using clinical specimens compared to NGS as the gold standard methodology. A total of fifty-eight (58) Formalin-Fixed Paraffin-Embedded tissue (FFPE) samples from fifty-three (53) patients diagnosed with advanced lung adenocarcinoma and 2 reference controls were used. Overall, the test presented 97,73% sensitivity, 100% specificity and 98,15% accuracy. The IntelliPlex Lung Cancer Panel DNA presented 98% agreement, and the IntelliPlex Lung Cancer Panel RNA presented 100% agreement between the results obtained from the CGP NGS methodology. The IntelliPlex Lung Cancer Panel by πCODE Technology demonstrates high specificity and sensitivity for use in clinical laboratories to routine detection for actionable mutations and fusions in NSCLC tumor samples, with high potential to become an alternative to broad NGS panels according to pre-analytical factors.https://doi.org/10.1038/s41598-025-10585-y |
| spellingShingle | Sandra Satie Koide Breno Jeha Araújo Juliana Doblas Massaro Renata de Godoy e Silva Rodrigo Dienstmann Fernanda Christtanini Koyama Ribeiro Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel Scientific Reports |
| title | Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel |
| title_full | Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel |
| title_fullStr | Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel |
| title_full_unstemmed | Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel |
| title_short | Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel |
| title_sort | validation of a rapid biomarker assay for lung cancer using the intelliplex panel |
| url | https://doi.org/10.1038/s41598-025-10585-y |
| work_keys_str_mv | AT sandrasatiekoide validationofarapidbiomarkerassayforlungcancerusingtheintelliplexpanel AT brenojehaaraujo validationofarapidbiomarkerassayforlungcancerusingtheintelliplexpanel AT julianadoblasmassaro validationofarapidbiomarkerassayforlungcancerusingtheintelliplexpanel AT renatadegodoyesilva validationofarapidbiomarkerassayforlungcancerusingtheintelliplexpanel AT rodrigodienstmann validationofarapidbiomarkerassayforlungcancerusingtheintelliplexpanel AT fernandachristtaninikoyamaribeiro validationofarapidbiomarkerassayforlungcancerusingtheintelliplexpanel |