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Author Details

Zivana Tezak
Center for Devices and Radiological Health
1992
30
17
PMIDPaper TitleJournal TitlePublished Year
37265412FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.Clin Cancer Res2023
37265412FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.Clin Cancer Res2023
34036290A community effort to identify and correct mislabeled samples in proteogenomic studies.Patterns (N Y)2021
34036290A community effort to identify and correct mislabeled samples in proteogenomic studies.Patterns (N Y)2021
34504347Establishing community reference samples, data and call sets for benchmarking cancer mutation detection using whole-genome sequencing.Nat Biotechnol2021
34504346Toward best practice in cancer mutation detection with whole-genome and whole-exome sequencing.Nat Biotechnol2021
34504347Establishing community reference samples, data and call sets for benchmarking cancer mutation detection using whole-genome sequencing.Nat Biotechnol2021
34504346Toward best practice in cancer mutation detection with whole-genome and whole-exome sequencing.Nat Biotechnol2021
30858580Best practices for benchmarking germline small-variant calls in human genomes.Nat Biotechnol2019
30858580Best practices for benchmarking germline small-variant calls in human genomes.Nat Biotechnol2019
30899106Author Correction: Best practices for benchmarking germline small-variant calls in human genomes.Nat Biotechnol2019
30899106Author Correction: Best practices for benchmarking germline small-variant calls in human genomes.Nat Biotechnol2019
30194412Right data for right patient-a precisionFDA NCI-CPTAC Multi-omics Mislabeling Challenge.Nat Med2018
30194412Right data for right patient-a precisionFDA NCI-CPTAC Multi-omics Mislabeling Challenge.Nat Med2018
28315672Principles and Recommendations for Standardizing the Use of the Next-Generation Sequencing Variant File in Clinical Settings.J Mol Diagn2017
28315672Principles and Recommendations for Standardizing the Use of the Next-Generation Sequencing Variant File in Clinical Settings.J Mol Diagn2017
27099173A research roadmap for next-generation sequencing informatics.Sci Transl Med2016
27099173A research roadmap for next-generation sequencing informatics.Sci Transl Med2016
25370936The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.Expert Rev Mol Diagn2015
25370936The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.Expert Rev Mol Diagn2015
24063748Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies.J Proteome Res2013
24063748Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies.J Proteome Res2013
22655855Characterization of whole genome amplified (WGA) DNA for use in genotyping assay development.BMC Genomics2012
22655855Characterization of whole genome amplified (WGA) DNA for use in genotyping assay development.BMC Genomics2012
21300740The journey to regulation of protein-based multiplex quantitative assays.Clin Chem2011
21300740The journey to regulation of protein-based multiplex quantitative assays.Clin Chem2011
21885623Direct-to-consumer genetic testing: reliable or risky?Clin Chem2011
21856459Regulatory perspective on translating proteomic biomarkers to clinical diagnostics.J Proteomics2011
21856459Regulatory perspective on translating proteomic biomarkers to clinical diagnostics.J Proteomics2011
21885623Direct-to-consumer genetic testing: reliable or risky?Clin Chem2011
20007858Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.Clin Chem2010
29776248US FDA and personalized medicine: in vitro diagnostic regulatory perspective.Per Med2010
22833953Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.Ther Deliv2010
20676074The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models.Nat Biotechnol2010
20007859Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.Clin Chem2010
20007858Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.Clin Chem2010
29776248US FDA and personalized medicine: in vitro diagnostic regulatory perspective.Per Med2010
22833953Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.Ther Deliv2010
20676074The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models.Nat Biotechnol2010
20007859Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.Clin Chem2010
24980716Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance.Drug Discov Today Technol2007
24980717Biomarkers for pharmacogenetic and pharmacogenomic studies: special issues in analytical performance.Drug Discov Today Technol2007
24980716Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance.Drug Discov Today Technol2007
24980717Biomarkers for pharmacogenetic and pharmacogenomic studies: special issues in analytical performance.Drug Discov Today Technol2007
16460648FDA perspectives on potential microarray-based clinical diagnostics.Hum Genomics2006
16964229The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.Nat Biotechnol2006
16460648FDA perspectives on potential microarray-based clinical diagnostics.Hum Genomics2006
16402088Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making.Pharmacogenomics J2006
16964229The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.Nat Biotechnol2006
16402088Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making.Pharmacogenomics J2006
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Collaborators

Co-authored papers 10
Office of Cancer Clinical Proteomics Research, National Cancer Institute
Co-authored papers 6
Virginia Tech
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Feil Family Brain and Mind Research Institute.
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Center for Devices and Radiological Health
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Office of Cancer Clinical Proteomics Research, National Cancer Institute
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National Institute of Standards and Technology
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National Center for Toxicological Research
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Department of Bioinformatics and Clinical Systems
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Stanford University
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Invitae Corporation
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Institute for Molecular Medicine Finland (FIMM), University of Helsinki
Co-authored papers 3
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Broad Institute of MIT and Harvard
Co-authored papers 3
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Chongqing Aier Eye Hospital
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