The current landscape of the FDA approved companion diagnostics
Predictive biomarker is an important element in the realization of precision medicine and with the introduction of the drug-diagnostic codevelopment model, the number of regulatory approved companion diagnostics (CDx) have steadily increased. This short perspective is based on an analysis of the FDA...
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| Format: | Article |
| Language: | English |
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Elsevier
2021-06-01
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| Series: | Translational Oncology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1936523321000553 |
| _version_ | 1818386243998711808 |
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| author | Jan Trøst Jørgensen |
| author_facet | Jan Trøst Jørgensen |
| author_sort | Jan Trøst Jørgensen |
| collection | DOAJ |
| description | Predictive biomarker is an important element in the realization of precision medicine and with the introduction of the drug-diagnostic codevelopment model, the number of regulatory approved companion diagnostics (CDx) have steadily increased. This short perspective is based on an analysis of the FDA List of Cleared or Approved Companion Diagnostic Devices and focus on the biomarkers, drugs, clinical indications, analytical platforms, regulatory paths and status related to the different assays. By the end of 2020, the total number of CDx assays approved by the FDA had reached 44. These assays are almost exclusively linked to different hematological and oncological drugs. Without an accurate and reliable CDx assay these drugs will lose their value. The analytical platforms are diverse and cover technologies like immunohistochemistry, in situ hybridization, polymerase chain reaction, next generation sequencing, and imaging. CDx assays are high risk devices and the regulatory path almost exclusively requires submission of a Premarket Application (PMA); however, a relatively large group of the CDx assays is PMA approved Laboratory Developed Test. |
| first_indexed | 2024-12-14T03:50:58Z |
| format | Article |
| id | doaj.art-66fa11382c174c4da80019b05680ea9c |
| institution | Directory Open Access Journal |
| issn | 1936-5233 |
| language | English |
| last_indexed | 2024-12-14T03:50:58Z |
| publishDate | 2021-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Translational Oncology |
| spelling | doaj.art-66fa11382c174c4da80019b05680ea9c2022-12-21T23:18:13ZengElsevierTranslational Oncology1936-52332021-06-01146101063The current landscape of the FDA approved companion diagnosticsJan Trøst Jørgensen0Dx-Rx Institute, Baunevaenget 76, 3480 Fredensborg, DenmarkPredictive biomarker is an important element in the realization of precision medicine and with the introduction of the drug-diagnostic codevelopment model, the number of regulatory approved companion diagnostics (CDx) have steadily increased. This short perspective is based on an analysis of the FDA List of Cleared or Approved Companion Diagnostic Devices and focus on the biomarkers, drugs, clinical indications, analytical platforms, regulatory paths and status related to the different assays. By the end of 2020, the total number of CDx assays approved by the FDA had reached 44. These assays are almost exclusively linked to different hematological and oncological drugs. Without an accurate and reliable CDx assay these drugs will lose their value. The analytical platforms are diverse and cover technologies like immunohistochemistry, in situ hybridization, polymerase chain reaction, next generation sequencing, and imaging. CDx assays are high risk devices and the regulatory path almost exclusively requires submission of a Premarket Application (PMA); however, a relatively large group of the CDx assays is PMA approved Laboratory Developed Test.http://www.sciencedirect.com/science/article/pii/S1936523321000553Companion diagnosticsBiomarkersPremarket applicationLaboratory developed testPrecision medicinePersonalized medicine |
| spellingShingle | Jan Trøst Jørgensen The current landscape of the FDA approved companion diagnostics Translational Oncology Companion diagnostics Biomarkers Premarket application Laboratory developed test Precision medicine Personalized medicine |
| title | The current landscape of the FDA approved companion diagnostics |
| title_full | The current landscape of the FDA approved companion diagnostics |
| title_fullStr | The current landscape of the FDA approved companion diagnostics |
| title_full_unstemmed | The current landscape of the FDA approved companion diagnostics |
| title_short | The current landscape of the FDA approved companion diagnostics |
| title_sort | current landscape of the fda approved companion diagnostics |
| topic | Companion diagnostics Biomarkers Premarket application Laboratory developed test Precision medicine Personalized medicine |
| url | http://www.sciencedirect.com/science/article/pii/S1936523321000553 |
| work_keys_str_mv | AT jantrøstjørgensen thecurrentlandscapeofthefdaapprovedcompaniondiagnostics AT jantrøstjørgensen currentlandscapeofthefdaapprovedcompaniondiagnostics |