FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine.
作者信息
Luh Frank, Yen Yun
机构信息
Sino-American Cancer Foundation, Temple City, CA USA.
2PhD Program of Cancer Biology and Drug Discovery, TMU Research Center of Cancer Translational Medicine, Taipei Medical University, Taipei, Taiwan.
出版信息
NPJ Genom Med. 2018 Oct 3;3:28. doi: 10.1038/s41525-018-0067-2. eCollection 2018.
Abstract
摘要
相似文献
1
FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine.
NPJ Genom Med. 2018 Oct 3;3:28. doi: 10.1038/s41525-018-0067-2. eCollection 2018.
2
Treatment recommendations to cancer patients in the context of FDA guidance for next generation sequencing.
BMC Med Inform Decis Mak. 2019 Jan 18;19(1):14. doi: 10.1186/s12911-019-0743-x.
3
Next-generation sequencing-based clinical sequencing: toward precision medicine in solid tumors.
Int J Clin Oncol. 2019 Feb;24(2):115-122. doi: 10.1007/s10147-018-1375-3. Epub 2018 Dec 4.
4
A Window Into Clinical Next-Generation Sequencing-Based Oncology Testing Practices.
Arch Pathol Lab Med. 2017 Dec;141(12):1679-1685. doi: 10.5858/arpa.2016-0542-CP. Epub 2017 Oct 13.
5
Clinical pharmacogenomics testing in the era of next generation sequencing: challenges and opportunities for precision medicine.
Expert Rev Mol Diagn. 2018 May;18(5):411-421. doi: 10.1080/14737159.2018.1461561. Epub 2018 Apr 23.
6
Current Policy Challenges in Genomic Medicine.
Clin Chem. 2020 Jan 1;66(1):61-67. doi: 10.1373/clinchem.2019.308775.
7
Next-Generation Sequencing: The Translational Medicine Approach from "Bench to Bedside to Population".
Medicines (Basel). 2016 Jun 2;3(2):14. doi: 10.3390/medicines3020014.
8
Clinical target sequencing for precision medicine of breast cancer.
Int J Clin Oncol. 2019 Feb;24(2):131-140. doi: 10.1007/s10147-018-1373-5. Epub 2019 Jan 2.
9
Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.
Breast Cancer. 2016 Jan;23(1):19-23. doi: 10.1007/s12282-015-0586-y. Epub 2015 Jan 22.
10
Clinical Next Generation Sequencing for Precision Medicine in Cancer.
Curr Genomics. 2015 Aug;16(4):253-63. doi: 10.2174/1389202915666150511205313.
引用本文的文献
1
Genetic Profiling of Acute and Chronic Leukemia via Next-Generation Sequencing: Current Insights and Future Perspectives.
Hematol Rep. 2025 Mar 28;17(2):18. doi: 10.3390/hematolrep17020018.
2
A Perspective on Artificial Intelligence for Molecular Pathologists.
J Mol Diagn. 2025 May;27(5):323-335. doi: 10.1016/j.jmoldx.2025.01.005. Epub 2025 Feb 13.
3
Enhancing Clinical Applications by Evaluation of Sensitivity and Specificity in Whole Exome Sequencing.
Int J Mol Sci. 2024 Dec 10;25(24):13250. doi: 10.3390/ijms252413250.
4
Paving the path for implementation of clinical genomic sequencing globally: Are we ready?
Health Aff Sch. 2024 Apr 29;2(5):qxae053. doi: 10.1093/haschl/qxae053. eCollection 2024 May.
5
Current status of the analytical validation of next generation sequencing applications for pharmacogenetic profiling.
Mol Biol Rep. 2023 Nov;50(11):9587-9599. doi: 10.1007/s11033-023-08748-z. Epub 2023 Oct 3.
6
Optimizing the clinical management of -mutant advanced non-small cell lung cancer: a literature review.
Transl Lung Cancer Res. 2022 May;11(5):935-949. doi: 10.21037/tlcr-22-1.
7
Next-generation sequencing for constitutional variants in the clinical laboratory, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG).
Genet Med. 2021 Aug;23(8):1399-1415. doi: 10.1038/s41436-021-01139-4. Epub 2021 Apr 29.
8
Application of Next Generation Sequencing in Laboratory Medicine.
Ann Lab Med. 2021 Jan;41(1):25-43. doi: 10.3343/alm.2021.41.1.25. Epub 2020 Aug 25.
9
Quality Control of Next-Generation Sequencing-Based HIV-1 Drug Resistance Data in Clinical Laboratory Information Systems Framework.
Viruses. 2020 Jun 14;12(6):645. doi: 10.3390/v12060645.
10
Computational Oncology in the Multi-Omics Era: State of the Art.
Front Oncol. 2020 Apr 7;10:423. doi: 10.3389/fonc.2020.00423. eCollection 2020.
本文引用的文献
1
The FDA and genomic tests--getting regulation right.
N Engl J Med. 2015 Jun 4;372(23):2258-64. doi: 10.1056/NEJMsr1501194. Epub 2015 May 27.
2
Charting a course for genomic medicine from base pairs to bedside.
Nature. 2011 Feb 10;470(7333):204-13. doi: 10.1038/nature09764.
3
Cytochrome p-450 polymorphisms and response to clopidogrel.
N Engl J Med. 2009 Jan 22;360(4):354-62. doi: 10.1056/NEJMoa0809171. Epub 2008 Dec 22.
4
Genomic medicine: genetic variation and its impact on the future of health care.
Philos Trans R Soc Lond B Biol Sci. 2005 Aug 29;360(1460):1543-50. doi: 10.1098/rstb.2005.1683.
Zotero 插件