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Items: 26

1.

Author Correction: Best practices for benchmarking germline small-variant calls in human genomes.

Krusche P, Trigg L, Boutros PC, Mason CE, De La Vega FM, Moore BL, Gonzalez-Porta M, Eberle MA, Tezak Z, Lababidi S, Truty R, Asimenos G, Funke B, Fleharty M, Chapman BA, Salit M, Zook JM; Global Alliance for Genomics and Health Benchmarking Team.

Nat Biotechnol. 2019 May;37(5):567. doi: 10.1038/s41587-019-0108-0.

PMID:
30899106
2.

Best practices for benchmarking germline small-variant calls in human genomes.

Krusche P, Trigg L, Boutros PC, Mason CE, De La Vega FM, Moore BL, Gonzalez-Porta M, Eberle MA, Tezak Z, Lababidi S, Truty R, Asimenos G, Funke B, Fleharty M, Chapman BA, Salit M, Zook JM; Global Alliance for Genomics and Health Benchmarking Team.

Nat Biotechnol. 2019 May;37(5):555-560. doi: 10.1038/s41587-019-0054-x. Epub 2019 Mar 11. Erratum in: Nat Biotechnol. 2019 Mar 21;:.

PMID:
30858580
3.

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

Boja E, Težak Ž, Zhang B, Wang P, Johanson E, Hinton D, Rodriguez H.

Nat Med. 2018 Sep;24(9):1301-1302. doi: 10.1038/s41591-018-0180-x. No abstract available.

PMID:
30194412
4.

Principles and Recommendations for Standardizing the Use of the Next-Generation Sequencing Variant File in Clinical Settings.

Lubin IM, Aziz N, Babb LJ, Ballinger D, Bisht H, Church DM, Cordes S, Eilbeck K, Hyland F, Kalman L, Landrum M, Lockhart ER, Maglott D, Marth G, Pfeifer JD, Rehm HL, Roy S, Tezak Z, Truty R, Ullman-Cullere M, Voelkerding KV, Worthey EA, Zaranek AW, Zook JM.

J Mol Diagn. 2017 May;19(3):417-426. doi: 10.1016/j.jmoldx.2016.12.001. Epub 2017 Mar 18.

5.

A research roadmap for next-generation sequencing informatics.

Altman RB, Prabhu S, Sidow A, Zook JM, Goldfeder R, Litwack D, Ashley E, Asimenos G, Bustamante CD, Donigan K, Giacomini KM, Johansen E, Khuri N, Lee E, Liang XS, Salit M, Serang O, Tezak Z, Wall DP, Mansfield E, Kass-Hout T.

Sci Transl Med. 2016 Apr 20;8(335):335ps10. doi: 10.1126/scitranslmed.aaf7314. Review.

6.

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

Bijwaard K, Dickey JS, Kelm K, Težak Ž.

Expert Rev Mol Diagn. 2015 Jan;15(1):33-40. doi: 10.1586/14737159.2015.979795. Epub 2014 Nov 5.

PMID:
25370936
7.

Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies.

Skates SJ, Gillette MA, LaBaer J, Carr SA, Anderson L, Liebler DC, Ransohoff D, Rifai N, Kondratovich M, Težak Ž, Mansfield E, Oberg AL, Wright I, Barnes G, Gail M, Mesri M, Kinsinger CR, Rodriguez H, Boja ES.

J Proteome Res. 2013 Dec 6;12(12):5383-94. doi: 10.1021/pr400132j. Epub 2013 Oct 28.

8.

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

Han T, Chang CW, Kwekel JC, Chen Y, Ge Y, Martinez-Murillo F, Roscoe D, Težak Z, Philip R, Bijwaard K, Fuscoe JC.

BMC Genomics. 2012 Jun 1;13:217. doi: 10.1186/1471-2164-13-217.

9.

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

Spencer DH, Lockwood C, Topol E, Evans JP, Green RC, Mansfield E, Tezak Z.

Clin Chem. 2011 Dec;57(12):1641-4. doi: 10.1373/clinchem.2011.167197. Epub 2011 Sep 1. No abstract available.

10.

Regulatory perspective on translating proteomic biomarkers to clinical diagnostics.

Li J, Kelm KB, Tezak Z.

J Proteomics. 2011 Nov 18;74(12):2682-90. doi: 10.1016/j.jprot.2011.07.028. Epub 2011 Aug 11. Review.

PMID:
21856459
11.

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

Boja ES, Jortani SA, Ritchie J, Hoofnagle AN, Težak Ž, Mansfield E, Keller P, Rivers RC, Rahbar A, Anderson NL, Srinivas P, Rodriguez H.

Clin Chem. 2011 Apr;57(4):560-7. doi: 10.1373/clinchem.2010.156034. Epub 2011 Feb 7.

12.

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

Sapsford KE, Tezak Z, Kondratovich M, Pacanowski MA, Zineh I, Mansfield E.

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

PMID:
22833953
13.

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

Težak Ž, Kondratovich MV, Mansfield E.

Per Med. 2010 Sep;7(5):517-530. doi: 10.2217/pme.10.53.

PMID:
29776248
14.

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

Shi L, Campbell G, Jones WD, Campagne F, Wen Z, Walker SJ, Su Z, Chu TM, Goodsaid FM, Pusztai L, Shaughnessy JD Jr, Oberthuer A, Thomas RS, Paules RS, Fielden M, Barlogie B, Chen W, Du P, Fischer M, Furlanello C, Gallas BD, Ge X, Megherbi DB, Symmans WF, Wang MD, Zhang J, Bitter H, Brors B, Bushel PR, Bylesjo M, Chen M, Cheng J, Cheng J, Chou J, Davison TS, Delorenzi M, Deng Y, Devanarayan V, Dix DJ, Dopazo J, Dorff KC, Elloumi F, Fan J, Fan S, Fan X, Fang H, Gonzaludo N, Hess KR, Hong H, Huan J, Irizarry RA, Judson R, Juraeva D, Lababidi S, Lambert CG, Li L, Li Y, Li Z, Lin SM, Liu G, Lobenhofer EK, Luo J, Luo W, McCall MN, Nikolsky Y, Pennello GA, Perkins RG, Philip R, Popovici V, Price ND, Qian F, Scherer A, Shi T, Shi W, Sung J, Thierry-Mieg D, Thierry-Mieg J, Thodima V, Trygg J, Vishnuvajjala L, Wang SJ, Wu J, Wu Y, Xie Q, Yousef WA, Zhang L, Zhang X, Zhong S, Zhou Y, Zhu S, Arasappan D, Bao W, Lucas AB, Berthold F, Brennan RJ, Buness A, Catalano JG, Chang C, Chen R, Cheng Y, Cui J, Czika W, Demichelis F, Deng X, Dosymbekov D, Eils R, Feng Y, Fostel J, Fulmer-Smentek S, Fuscoe JC, Gatto L, Ge W, Goldstein DR, Guo L, Halbert DN, Han J, Harris SC, Hatzis C, Herman D, Huang J, Jensen RV, Jiang R, Johnson CD, Jurman G, Kahlert Y, Khuder SA, Kohl M, Li J, Li L, Li M, Li QZ, Li S, Li Z, Liu J, Liu Y, Liu Z, Meng L, Madera M, Martinez-Murillo F, Medina I, Meehan J, Miclaus K, Moffitt RA, Montaner D, Mukherjee P, Mulligan GJ, Neville P, Nikolskaya T, Ning B, Page GP, Parker J, Parry RM, Peng X, Peterson RL, Phan JH, Quanz B, Ren Y, Riccadonna S, Roter AH, Samuelson FW, Schumacher MM, Shambaugh JD, Shi Q, Shippy R, Si S, Smalter A, Sotiriou C, Soukup M, Staedtler F, Steiner G, Stokes TH, Sun Q, Tan PY, Tang R, Tezak Z, Thorn B, Tsyganova M, Turpaz Y, Vega SC, Visintainer R, von Frese J, Wang C, Wang E, Wang J, Wang W, Westermann F, Willey JC, Woods M, Wu S, Xiao N, Xu J, Xu L, Yang L, Zeng X, Zhang J, Zhang L, Zhang M, Zhao C, Puri RK, Scherf U, Tong W, Wolfinger RD; MAQC Consortium.

Nat Biotechnol. 2010 Aug;28(8):827-38. doi: 10.1038/nbt.1665. Epub 2010 Jul 30.

15.

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

Rodriguez H, Tezak Z, Mesri M, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Philip R, Ransohoff DF, Skates SJ, Regnier FE, Anderson NL, Mansfield E; Workshop Participants.

Clin Chem. 2010 Feb;56(2):237-43. doi: 10.1373/clinchem.2009.136416. Epub 2009 Dec 10. Review.

16.

Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.

Regnier FE, Skates SJ, Mesri M, Rodriguez H, Tezak Z, Kondratovich MV, Alterman MA, Levin JD, Roscoe D, Reilly E, Callaghan J, Kelm K, Brown D, Philip R, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Ransohoff DF, Mansfield E, Anderson NL.

Clin Chem. 2010 Feb;56(2):165-71. doi: 10.1373/clinchem.2009.140087. Epub 2009 Dec 10.

17.

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

Mansfield E, Tezak Z, Altaie S, Simon K, Gutman S.

Drug Discov Today Technol. 2007 Autumn;4(1):21-4. doi: 10.1016/j.ddtec.2007.10.001.

PMID:
24980717
18.

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

Mansfield E, Tezak Z, Altaie S, Simon K, Gutman S.

Drug Discov Today Technol. 2007 Autumn;4(1):17-20. doi: 10.1016/j.ddtec.2007.10.002.

PMID:
24980716
19.

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

MAQC Consortium, Shi L, Reid LH, Jones WD, Shippy R, Warrington JA, Baker SC, Collins PJ, de Longueville F, Kawasaki ES, Lee KY, Luo Y, Sun YA, Willey JC, Setterquist RA, Fischer GM, Tong W, Dragan YP, Dix DJ, Frueh FW, Goodsaid FM, Herman D, Jensen RV, Johnson CD, Lobenhofer EK, Puri RK, Schrf U, Thierry-Mieg J, Wang C, Wilson M, Wolber PK, Zhang L, Amur S, Bao W, Barbacioru CC, Lucas AB, Bertholet V, Boysen C, Bromley B, Brown D, Brunner A, Canales R, Cao XM, Cebula TA, Chen JJ, Cheng J, Chu TM, Chudin E, Corson J, Corton JC, Croner LJ, Davies C, Davison TS, Delenstarr G, Deng X, Dorris D, Eklund AC, Fan XH, Fang H, Fulmer-Smentek S, Fuscoe JC, Gallagher K, Ge W, Guo L, Guo X, Hager J, Haje PK, Han J, Han T, Harbottle HC, Harris SC, Hatchwell E, Hauser CA, Hester S, Hong H, Hurban P, Jackson SA, Ji H, Knight CR, Kuo WP, LeClerc JE, Levy S, Li QZ, Liu C, Liu Y, Lombardi MJ, Ma Y, Magnuson SR, Maqsodi B, McDaniel T, Mei N, Myklebost O, Ning B, Novoradovskaya N, Orr MS, Osborn TW, Papallo A, Patterson TA, Perkins RG, Peters EH, Peterson R, Philips KL, Pine PS, Pusztai L, Qian F, Ren H, Rosen M, Rosenzweig BA, Samaha RR, Schena M, Schroth GP, Shchegrova S, Smith DD, Staedtler F, Su Z, Sun H, Szallasi Z, Tezak Z, Thierry-Mieg D, Thompson KL, Tikhonova I, Turpaz Y, Vallanat B, Van C, Walker SJ, Wang SJ, Wang Y, Wolfinger R, Wong A, Wu J, Xiao C, Xie Q, Xu J, Yang W, Zhang L, Zhong S, Zong Y, Slikker W Jr.

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

20.

FDA perspectives on potential microarray-based clinical diagnostics.

Tezak Z, Ranamukhaarachchi D, Russek-Cohen E, Gutman SI.

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

21.

Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making.

Trepicchio WL, Essayan D, Hall ST, Schechter G, Tezak Z, Wang SJ, Weinreich D, Simon R.

Pharmacogenomics J. 2006 Mar-Apr;6(2):89-94. No abstract available.

PMID:
16402088
22.

Clinical and molecular study in congenital muscular dystrophy with partial laminin alpha 2 (LAMA2) deficiency.

Tezak Z, Prandini P, Boscaro M, Marin A, Devaney J, Marino M, Fanin M, Trevisan CP, Park J, Tyson W, Finkel R, Garcia C, Angelini C, Hoffman EP, Pegoraro E.

Hum Mutat. 2003 Feb;21(2):103-11.

PMID:
12552556
23.

Gene expression profiling in DQA1*0501+ children with untreated dermatomyositis: a novel model of pathogenesis.

Tezak Z, Hoffman EP, Lutz JL, Fedczyna TO, Stephan D, Bremer EG, Krasnoselska-Riz I, Kumar A, Pachman LM.

J Immunol. 2002 Apr 15;168(8):4154-63.

24.

Massive muscle cell degeneration in the early stage of merosin-deficient congenital muscular dystrophy.

Hayashi YK, Tezak Z, Momoi T, Nonaka I, Garcia CA, Hoffman EP, Arahata K.

Neuromuscul Disord. 2001 May;11(4):350-9.

PMID:
11369186
25.

Adeno-associated virus in normal and myositis human skeletal muscle.

Tezak Z, Nagaraju K, Plotz P, Hoffman EP.

Neurology. 2000 Dec 26;55(12):1913-7.

PMID:
11134397
26.

Effect of pesticides on oestradiol-receptor complex formation in rat uterus cytosol.

Tezak Z, Simić B, Kniewald J.

Food Chem Toxicol. 1992 Oct;30(10):879-85.

PMID:
1385282

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