Guidance for securing approvals for new biomarkers: from discovery to clinical implementation-Reference-Cited by-同舟云学术

Guidance for securing approvals for new biomarkers: from discovery to clinical implementation

Published:2024-07-31 Issue: Volume: Page:1-8
ISSN:1040-8363
Container-title:Critical Reviews in Clinical Laboratory Sciences
language:en
Short-container-title:Critical Reviews in Clinical Laboratory Sciences

Author:

Feilotter Harriet¹,Bruce Christine²³,Diamandis Eleftherios P.⁴,Chatanaka Miyo K.³,Yousef George M.²³

Affiliation:

1. Department of Pathology and Molecular Medicine, Queen’s University, Kingston, ON, Canada

2. Laboratory Medicine Program, University Health Network, Toronto, ON, Canada

3. Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada

4. Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Sinai Health System, Toronto, Canada

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/10408363.2024.2379278

Reference26 articles.

1. Is Molecular Profiling Ready for Use in Clinical Decision Making?

2. FDA. Focus Area: biomarkers; 2022 [Internet] [cited 2023 Aug 16]. Available from: https://www.fda.gov/science-research/focus-areas-regulatory-science-report/focus-area-biomarkers#:∼:text=Biomarkers%20are%20characteristics%20that%20are or%20intervention%2C%20including%20therapeutic%20interventions.

3. National Cancer Institute. NCI dictionary of cancer terms [Internet]; [cited 2024 Jun 3]. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/molecular-testing.

4. Updates on breast biomarkers

5. Genetics in Medicine. Nature. American College of Medical Genetics (ACMG) statement and guidelines [Internet]; [cited 2023 Aug 16]. Available from: https://www.nature.com/collections/afebagafci.

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