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The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics

The evolution of chemistries and instrument platforms for next‐generation sequencing has led to sequencing of genomic variants in both tumor biopsies as well as in circulating tumor cells (CTCs) and cell‐free DNA liquid biopsies. The transition of these analytical platforms into clinical ones has le...

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Autor principal: Goodsaid, Federico M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742934/
https://www.ncbi.nlm.nih.gov/pubmed/31162800
http://dx.doi.org/10.1111/cts.12657
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author Goodsaid, Federico M.
author_facet Goodsaid, Federico M.
author_sort Goodsaid, Federico M.
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description The evolution of chemistries and instrument platforms for next‐generation sequencing has led to sequencing of genomic variants in both tumor biopsies as well as in circulating tumor cells (CTCs) and cell‐free DNA liquid biopsies. The transition of these analytical platforms into clinical ones has led to challenges in product development as well as regulatory strategies for the approval of diagnostic products with these platforms. Regulatory strategies for liquid biopsy diagnostics depend on a framework that has been developed over the past few years by the US Food and Drug Administration (FDA). This framework includes both guidances that cover enrichment biomarkers and companion diagnostics, as well as regulatory approval precedents, which can be used to design regulatory strategies for new liquid biopsy diagnostic products. However, the regulatory paths for these liquid biopsy diagnostics can also be tortuous, as is the example of CTC—platform liquid biopsies. The ultimate success of regulatory pathways of liquid biopsy diagnostics has been driven by the incremental value of FDA approval for Clinical Laboratory Improvement Amendment (CLIA)‐developed tests and by the inherent complexity of these diagnostics, which are practical barriers for the widespread replication of these tests throughout CLIA laboratories. The framework for FDA approval of sequence information from these liquid biopsies has been focused on single‐site approvals of diagnostics where sequencing information is considered at different diagnostic risk levels, ranging from novel or follow‐on companion diagnostics to variant calls in genomic targets considered independently valuable for therapeutic decision making.
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spelling pubmed-67429342019-09-14 The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics Goodsaid, Federico M. Clin Transl Sci Review The evolution of chemistries and instrument platforms for next‐generation sequencing has led to sequencing of genomic variants in both tumor biopsies as well as in circulating tumor cells (CTCs) and cell‐free DNA liquid biopsies. The transition of these analytical platforms into clinical ones has led to challenges in product development as well as regulatory strategies for the approval of diagnostic products with these platforms. Regulatory strategies for liquid biopsy diagnostics depend on a framework that has been developed over the past few years by the US Food and Drug Administration (FDA). This framework includes both guidances that cover enrichment biomarkers and companion diagnostics, as well as regulatory approval precedents, which can be used to design regulatory strategies for new liquid biopsy diagnostic products. However, the regulatory paths for these liquid biopsy diagnostics can also be tortuous, as is the example of CTC—platform liquid biopsies. The ultimate success of regulatory pathways of liquid biopsy diagnostics has been driven by the incremental value of FDA approval for Clinical Laboratory Improvement Amendment (CLIA)‐developed tests and by the inherent complexity of these diagnostics, which are practical barriers for the widespread replication of these tests throughout CLIA laboratories. The framework for FDA approval of sequence information from these liquid biopsies has been focused on single‐site approvals of diagnostics where sequencing information is considered at different diagnostic risk levels, ranging from novel or follow‐on companion diagnostics to variant calls in genomic targets considered independently valuable for therapeutic decision making. John Wiley and Sons Inc. 2019-07-01 2019-09 /pmc/articles/PMC6742934/ /pubmed/31162800 http://dx.doi.org/10.1111/cts.12657 Text en © 2019 The Author. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Review
Goodsaid, Federico M.
The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics
title The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics
title_full The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics
title_fullStr The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics
title_full_unstemmed The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics
title_short The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics
title_sort labyrinth of product development and regulatory approvals in liquid biopsy diagnostics
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742934/
https://www.ncbi.nlm.nih.gov/pubmed/31162800
http://dx.doi.org/10.1111/cts.12657
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