Zivana Tezak

Zivana Tezak

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Zivana Tezak

Publications by authors named "Zivana Tezak"

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22Publications

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Right data for right patient-a precisionFDA NCI-CPTAC Multi-omics Mislabeling Challenge.

Nat Med 2018 09;24(9):1301-1302

Office of Cancer Clinical Proteomics Research, Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

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http://www.nature.com/articles/s41591-018-0180-x
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http://dx.doi.org/10.1038/s41591-018-0180-xDOI Listing
September 2018

The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.

Expert Rev Mol Diagn 2015 Jan 5;15(1):33-40. Epub 2014 Nov 5.

Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, US FDA, 10903 New Hampshire Ave, Silver Spring, 20993, USA.

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http://dx.doi.org/10.1586/14737159.2015.979795DOI Listing
January 2015

Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance.

Drug Discov Today Technol 2007 ;4(1):17-20

Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.

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http://dx.doi.org/10.1016/j.ddtec.2007.10.002DOI Listing
July 2014

Biomarkers for pharmacogenetic and pharmacogenomic studies: special issues in analytical performance.

Drug Discov Today Technol 2007 ;4(1):21-4

Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, United States.

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http://dx.doi.org/10.1016/j.ddtec.2007.10.001DOI Listing
July 2014

Characterization of whole genome amplified (WGA) DNA for use in genotyping assay development.

BMC Genomics 2012 Jun 1;13:217. Epub 2012 Jun 1.

Division of Systems Biology, National Center for Toxicological Research, FDA, Jefferson, AR 72079, USA.

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http://dx.doi.org/10.1186/1471-2164-13-217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3403925PMC
June 2012

Direct-to-consumer genetic testing: reliable or risky?

Clin Chem 2011 Dec 1;57(12):1641-4. Epub 2011 Sep 1.

Washington University/Barnes-Jewish Hospital, St. Louis, MO, USA.

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http://dx.doi.org/10.1373/clinchem.2011.167197DOI Listing
December 2011

Regulatory perspective on translating proteomic biomarkers to clinical diagnostics.

J Proteomics 2011 Nov 11;74(12):2682-90. Epub 2011 Aug 11.

Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States.

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http://dx.doi.org/10.1016/j.jprot.2011.07.028DOI Listing
November 2011

The journey to regulation of protein-based multiplex quantitative assays.

Clin Chem 2011 Apr 7;57(4):560-7. Epub 2011 Feb 7.

Office of Cancer Clinical Proteomics Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1373/clinchem.2010.156034DOI Listing
April 2011

Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.

Ther Deliv 2010 Nov;1(5):631-41

Division of Biology, Office of Science & Engineering Laboratories, CDRH, US Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

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November 2010

US FDA and personalized medicine: in vitro diagnostic regulatory perspective.

Per Med 2010 Sep;7(5):517-530

Personalized Medicine Staff, Office of In Vitro Diagnostic Device Evaluation & Safety, Center for Devices & Radiological Health, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.

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http://dx.doi.org/10.2217/pme.10.53DOI Listing
September 2010

The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models.

Authors:
Leming Shi Gregory Campbell Wendell D Jones Fabien Campagne Zhining Wen Stephen J Walker Zhenqiang Su Tzu-Ming Chu Federico M Goodsaid Lajos Pusztai John D Shaughnessy André Oberthuer Russell S Thomas Richard S Paules Mark Fielden Bart Barlogie Weijie Chen Pan Du Matthias Fischer Cesare Furlanello Brandon D Gallas Xijin Ge Dalila B Megherbi W Fraser Symmans May D Wang John Zhang Hans Bitter Benedikt Brors Pierre R Bushel Max Bylesjo Minjun Chen Jie Cheng Jing Cheng Jeff Chou Timothy S Davison Mauro Delorenzi Youping Deng Viswanath Devanarayan David J Dix Joaquin Dopazo Kevin C Dorff Fathi Elloumi Jianqing Fan Shicai Fan Xiaohui Fan Hong Fang Nina Gonzaludo Kenneth R Hess Huixiao Hong Jun Huan Rafael A Irizarry Richard Judson Dilafruz Juraeva Samir Lababidi Christophe G Lambert Li Li Yanen Li Zhen Li Simon M Lin Guozhen Liu Edward K Lobenhofer Jun Luo Wen Luo Matthew N McCall Yuri Nikolsky Gene A Pennello Roger G Perkins Reena Philip Vlad Popovici Nathan D Price Feng Qian Andreas Scherer Tieliu Shi Weiwei Shi Jaeyun Sung Danielle Thierry-Mieg Jean Thierry-Mieg Venkata Thodima Johan Trygg Lakshmi Vishnuvajjala Sue Jane Wang Jianping Wu Yichao Wu Qian Xie Waleed A Yousef Liang Zhang Xuegong Zhang Sheng Zhong Yiming Zhou Sheng Zhu Dhivya Arasappan Wenjun Bao Anne Bergstrom Lucas Frank Berthold Richard J Brennan Andreas Buness Jennifer G Catalano Chang Chang Rong Chen Yiyu Cheng Jian Cui Wendy Czika Francesca Demichelis Xutao Deng Damir Dosymbekov Roland Eils Yang Feng Jennifer Fostel Stephanie Fulmer-Smentek James C Fuscoe Laurent Gatto Weigong Ge Darlene R Goldstein Li Guo Donald N Halbert Jing Han Stephen C Harris Christos Hatzis Damir Herman Jianping Huang Roderick V Jensen Rui Jiang Charles D Johnson Giuseppe Jurman Yvonne Kahlert Sadik A Khuder Matthias Kohl Jianying Li Li Li Menglong Li Quan-Zhen Li Shao Li Zhiguang Li Jie Liu Ying Liu Zhichao Liu Lu Meng Manuel Madera Francisco Martinez-Murillo Ignacio Medina Joseph Meehan Kelci Miclaus Richard A Moffitt David Montaner Piali Mukherjee George J Mulligan Padraic Neville Tatiana Nikolskaya Baitang Ning Grier P Page Joel Parker R Mitchell Parry Xuejun Peng Ron L Peterson John H Phan Brian Quanz Yi Ren Samantha Riccadonna Alan H Roter Frank W Samuelson Martin M Schumacher Joseph D Shambaugh Qiang Shi Richard Shippy Shengzhu Si Aaron Smalter Christos Sotiriou Mat Soukup Frank Staedtler Guido Steiner Todd H Stokes Qinglan Sun Pei-Yi Tan Rong Tang Zivana Tezak Brett Thorn Marina Tsyganova Yaron Turpaz Silvia C Vega Roberto Visintainer Juergen von Frese Charles Wang Eric Wang Junwei Wang Wei Wang Frank Westermann James C Willey Matthew Woods Shujian Wu Nianqing Xiao Joshua Xu Lei Xu Lun Yang Xiao Zeng Jialu Zhang Li Zhang Min Zhang Chen Zhao Raj K Puri Uwe Scherf Weida Tong Russell D Wolfinger

Nat Biotechnol 2010 Aug 30;28(8):827-38. Epub 2010 Jul 30.

National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.

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http://dx.doi.org/10.1038/nbt.1665DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3315840PMC
August 2010

Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.

Clin Chem 2010 Feb 10;56(2):237-43. Epub 2009 Dec 10.

National Cancer Institute-Food and Drug Administration Interagency Oncology Task Force on Molecular Diagnostics, National Institutes of Health, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1373/clinchem.2009.136416DOI Listing
February 2010

The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.

Authors:
Leming Shi Laura H Reid Wendell D Jones Richard Shippy Janet A Warrington Shawn C Baker Patrick J Collins Francoise de Longueville Ernest S Kawasaki Kathleen Y Lee Yuling Luo Yongming Andrew Sun James C Willey Robert A Setterquist Gavin M Fischer Weida Tong Yvonne P Dragan David J Dix Felix W Frueh Frederico M Goodsaid Damir Herman Roderick V Jensen Charles D Johnson Edward K Lobenhofer Raj K Puri Uwe Schrf Jean Thierry-Mieg Charles Wang Mike Wilson Paul K Wolber Lu Zhang Shashi Amur Wenjun Bao Catalin C Barbacioru Anne Bergstrom Lucas Vincent Bertholet Cecilie Boysen Bud Bromley Donna Brown Alan Brunner Roger Canales Xiaoxi Megan Cao Thomas A Cebula James J Chen Jing Cheng Tzu-Ming Chu Eugene Chudin John Corson J Christopher Corton Lisa J Croner Christopher Davies Timothy S Davison Glenda Delenstarr Xutao Deng David Dorris Aron C Eklund Xiao-hui Fan Hong Fang Stephanie Fulmer-Smentek James C Fuscoe Kathryn Gallagher Weigong Ge Lei Guo Xu Guo Janet Hager Paul K Haje Jing Han Tao Han Heather C Harbottle Stephen C Harris Eli Hatchwell Craig A Hauser Susan Hester Huixiao Hong Patrick Hurban Scott A Jackson Hanlee Ji Charles R Knight Winston P Kuo J Eugene LeClerc Shawn Levy Quan-Zhen Li Chunmei Liu Ying Liu Michael J Lombardi Yunqing Ma Scott R Magnuson Botoul Maqsodi Tim McDaniel Nan Mei Ola Myklebost Baitang Ning Natalia Novoradovskaya Michael S Orr Terry W Osborn Adam Papallo Tucker A Patterson Roger G Perkins Elizabeth H Peters Ron Peterson Kenneth L Philips P Scott Pine Lajos Pusztai Feng Qian Hongzu Ren Mitch Rosen Barry A Rosenzweig Raymond R Samaha Mark Schena Gary P Schroth Svetlana Shchegrova Dave D Smith Frank Staedtler Zhenqiang Su Hongmei Sun Zoltan Szallasi Zivana Tezak Danielle Thierry-Mieg Karol L Thompson Irina Tikhonova Yaron Turpaz Beena Vallanat Christophe Van Stephen J Walker Sue Jane Wang Yonghong Wang Russ Wolfinger Alex Wong Jie Wu Chunlin Xiao Qian Xie Jun Xu Wen Yang Liang Zhang Sheng Zhong Yaping Zong William Slikker

Nat Biotechnol 2006 Sep;24(9):1151-61

National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas 72079, USA.

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http://dx.doi.org/10.1038/nbt1239DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272078PMC
September 2006

FDA perspectives on potential microarray-based clinical diagnostics.

Hum Genomics 2006 Jan;2(4):236-43

Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD 20850, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3525154PMC
January 2006