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Biomarkers: The Indispensable Healthcare Tools


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1 Project & Portfolio Manager, Yashraj Biotechnology Limited, Mumbai-400705, India., India
 

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Biomarkers have reformed the game of diagnosis and prognosis of diseased conditions over the last 50 years. They have become powerful tools to classify patients according to their risk of disease progression, severity of the disease and guide drug therapy. The Food and Drug Administration (FDA) currently listed over 39 biomarkers that may be used as outcomes for FDAapproved therapeutics. Moreover, in association with NIH, FDA has published the B.E.S.T. resource to establish uniformity and harmonization categorically for the discussion of biomarkers. This article briefly touches upon this harmonization and uniformity brought in by FDA and NIH in terms of discussions related to biomarkers for the ease of everyone’s understanding and information, its Biomarker Qualifying Programme, what are the Top 10 diseases causing deaths worldwide according to WHO and which biomarkers are used for their diagnosis and prognosis. Briefly, this article captures how far we have progressed in these 50 years and how elusive and distant the dream of gold standard biomarkers still is.


Keywords

Biomarkers, FDA, NIH, FDA-NIH Biomarker Working Group, B.E.S.T resource, WHO
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  • Food and Drug Administration [Internet]. Available from: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-biomarkers-working-group# :~:text=The%20mission%20of%20the%20FDA,may%20 help%20address%20challenges%3B%20and

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  • Food and Drug Administration[Internet]. Available from: https://www.fda.gov/drugs/biomarker-qualification-program/list-qualified-biomarkers

  • Füzéry AK, Levin J, Chan MM, Chan DW. Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges. Clin Proteomics. 2013 Oct 2;10(1):13.

  • World Health Organization [Internet]. The Top 10 Causes of Death. Dec 9, 2020. Available from: https://www.who.int/ news-room/fact-sheets/detail/the-top-10-causes-of-death


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  • Biomarkers: The Indispensable Healthcare Tools

Abstract Views: 188  |  PDF Views: 122

Authors

Gauri Awasthi
Project & Portfolio Manager, Yashraj Biotechnology Limited, Mumbai-400705, India., India

Abstract


Biomarkers have reformed the game of diagnosis and prognosis of diseased conditions over the last 50 years. They have become powerful tools to classify patients according to their risk of disease progression, severity of the disease and guide drug therapy. The Food and Drug Administration (FDA) currently listed over 39 biomarkers that may be used as outcomes for FDAapproved therapeutics. Moreover, in association with NIH, FDA has published the B.E.S.T. resource to establish uniformity and harmonization categorically for the discussion of biomarkers. This article briefly touches upon this harmonization and uniformity brought in by FDA and NIH in terms of discussions related to biomarkers for the ease of everyone’s understanding and information, its Biomarker Qualifying Programme, what are the Top 10 diseases causing deaths worldwide according to WHO and which biomarkers are used for their diagnosis and prognosis. Briefly, this article captures how far we have progressed in these 50 years and how elusive and distant the dream of gold standard biomarkers still is.


Keywords


Biomarkers, FDA, NIH, FDA-NIH Biomarker Working Group, B.E.S.T resource, WHO

References