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Retricted access

Research article

First published 2018-2

Regulatory landscapes for biomarkers and diagnostic tests: Qualification,approval,and role in clinical practice

William B. Mattes, Federico Goodsaid

Experimental Biology and Medicine

Retricted access

Review article

First published 2011-09

Diagnostic Testing for Vaccinomics: Is the Regulatory Approval Framework Adequate? A Comparison of Canada,the United States,and Europe

Yann Joly, Georgia Koutrikas, Emma Ramos-Paque [...]

OMICS: A Journal of Integrative Biology

Open access

Research article

First published 2018-10

Toward Alignment in the Reporting of Economic Evaluations of Diagnostic Tests and Biomarkers: The AGREEDT Checklist

Michelle M.A. Kip, Maarten J. IJzerman, Martin Henriksson [...]

Medical Decision Making

Open access

Review article

First published 2021

Companion Diagnostics: State of the Art and New Regulations

Vasiliki Valla, Saba Alzabin, Angeliki Koukoura [...]

Biomarker Insights

Retricted access

Research article

First published 2023-3

Implementation of abbreviated breast MRI in diagnostic and screening settings

Nasrin Ahmadinejad, Shilan Azhdeh, Arvin Arian [...]

Acta Radiologica

Open access

Research article

First published 2016-7

Impact of the “Linked Evidence Approach” Method on Policies to Publicly Fund Diagnostic,Staging,and Screening Medical Tests

Tracy L. Merlin, Janet E. Hiller, Philip Ryan

MDM Policy & Practice

Open access

Case report

First published 2023-6

L858R-K860I Doublet Mutation of EGFR gene in Non-Small Cell Lung Carcinoma: Cause of a False Negative Call for L858R on Initial Companion Diagnostic Test

Anurag Mehta, Himanshi Diwan, Shrinidhi Nathany [...]

Journal of Current Oncology

Free access

Review article

First published 2014-1

Detection of Fetal Aneuploidy Using Cell-Free DNA

Kristin E. Webb

Journal of Diagnostic Medical Sonography

Free access

Research article

First published 2005-7

Standards and controls for genetic testing

Emily S. Winn-Deen

Cancer Biomarkers

Retricted access

Research article

First published 2008-6

Quantitative expediency assessment of the zeta sedimentation ratio and the plasma viscosity in arterial hypertension research

S. Stoeff, Sv. Jovtchev, I. Dikov [...]

Clinical Hemorheology and Microcirculation

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