Considerations for drug development biomarker assays in the clinical laboratory

BioanalysisVol. 15, No. 10 CommentaryConsiderations for drug development biomarker assays in the clinical laboratoryMark E Arnold, John L Allinson & Steven P PiccoliMark E Arnold *Author for correspondence: E-mail Address: mark.arnoldcs@gmail.comhttps://orcid.org/0000-0002-6961-433XBioanalytical Solution Integration, Westampton, NJ 08060, USA, John L Allinson https://orcid.org/0000-0002-9375-8026Immunologix Laboratories, Biomarker Laboratory, Immunologix Laboratories, Tampa, FL 33634, USA & Steven P Piccoli https://orcid.org/0000-0002-9355-6651Clinical Sciences, Sun Pharma Advanced Research Company Ltd., Cranbury, NJ 08512, USAPublished Online:9 Jun 2023https://doi.org/10.4155/bio-2023-0101AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: biomarkersBMVCAPCLIAclinical laboratorycontext of usedrug developmentregulationsUS FDAvalidationReferences1. US FDA. National Institute of Health (FDA-NIH), FDA-NIH Biomarker Working Group. Biomarkers, EndpointS, and other Tools Resource [Internet] Glossary (2023). http://www.ncbi.nlm.nih.gov/books/NBK338448/Google Scholar2. US FDA. Bioanalytical Method Validation; guidance for industry (2018). www.fda.gov/downloads/drugs/guidances/UCM070107.pdfGoogle Scholar3. Ohtsu Y, Tanaka S, Igarashi H et al. Analytical method validation for biomarkers as a drug development tool: points to consider. Bioanalysis 13(18), 1379–1389 (2021).Link, CAS, Google Scholar4. Japan Ministry of Health, Labour and Welfare. Guideline on bioanalytical method validation in pharmaceutical development (2013). https://www.pmda.go.jp/files/000206209.pdfGoogle Scholar5. Japan Ministry of Health, Labour and Welfare. Guideline on bioanalytical method (ligand binding assay) validation in pharmaceutical development (2014). https://www.pmda.go.jp/files/000206208.pdfGoogle Scholar6. Biomarker Assay Collaborative Evidentiary Considerations Writing Group, Critical Path Institute. Points to Consider document: scientific and regulatory considerations for the analytical validation of assays used in the qualification of biomarkers in biological matrices (2019). https://c-path.org/wp-content/uploads/2019/06/evidconsid-whitepaper-analyticalsectionv2019.pdfGoogle ScholarFiguresReferencesRelatedDetails Vol. 15, No. 10 STAY CONNECTED Metrics Downloaded 160 times History Received 19 May 2023 Accepted 25 May 2023 Published online 9 June 2023 Published in print May 2023 Information© 2023 Newlands PressKeywordsbiomarkersBMVCAPCLIAclinical laboratorycontext of usedrug developmentregulationsUS FDAvalidationFinancial & competing interests disclosureThe authors work for companies that develop or advise clients on biomarker assays and received no financial support from those clients to prepare the article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.PDF download