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Expert Review of Molecular Diagnostics Volume 15, 2015 - Issue 1
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Special Reports

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

Karen BijwaardDivision 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
,
Jennifer S DickeyDivision 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
,
Kellie KelmDivision of Chemistry and Toxicology Devices, OIR, CDRH, US FDA, 10903 New Hampshire Ave, Silver Spring, 20993, USA
&
Živana TežakPersonalized Medicine Staff, OIR, Center for Devices and Radiological Health (CDRH), US FDA, 10903 New Hampshire Ave, Silver Spring, 20993, USACorrespondence[email protected]
Pages 33-40 | Published online: 05 Nov 2014

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Monica Brenca & Roberta Maestro. (2015) Massive parallel sequencing in sarcoma pathobiology: state of the art and perspectives. Expert Review of Anticancer Therapy 15:12, pages 1473-1488.
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Articles from other publishers (7)

Tiago César Gouvêa Moreira, Pricila Da Silva Spínola, Micheline Campos Rezende, Carla Simone Moreira de Freitas, Fábio Borges Mury, Cibele Rodrigues Bonvicino & Luciana De Andrade Agostinho. (2021) Correlation between the number of false positive variants and the quality of results using Ion Torrent PGM™ sequencing to screen BRCA genes. Biomédica 41:4, pages 773-786.
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John R. ten Bosch & Wayne W. Grody. 2019. Genomic Applications in Pathology. Genomic Applications in Pathology 11 21 .
Dervla Kelly, Nigar Anjuman Khurram, Richard A. Hickman & Zhiheng Pei. 2018. Advanced Techniques in Diagnostic Microbiology. Advanced Techniques in Diagnostic Microbiology 599 615 .
Chih-Jian Lih, Robin D. Harrington, David J. Sims, Kneshay N. Harper, Courtney H. Bouk, Vivekananda Datta, Jonathan Yau, Rajesh R. Singh, Mark J. Routbort, Rajyalakshmi Luthra, Keyur P. Patel, Geeta S. Mantha, Savitri Krishnamurthy, Karyn Ronski, Zenta Walther, Karin E. Finberg, Sandra Canosa, Hayley Robinson, Amelia Raymond, Long P. Le, Lisa M. McShane, Eric C. Polley, Barbara A. Conley, James H. Doroshow, A. John Iafrate, Jeffrey L. Sklar, Stanley R. Hamilton & P. Mickey Williams. (2017) Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial. The Journal of Molecular Diagnostics 19:2, pages 313-327.
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Alina P.S. Pang, Christopher Sugai & Alika K. Maunakea. (2016) High-throughput sequencing offers new insights into 5-hydroxymethylcytosine. Biomolecular Concepts 7:3, pages 169-178.
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Jun-Seok Bae, Nayoung K.D. Kim, Chung Lee, Sang Cheol Kim, Hey Ran Lee, Hae-Ryong Song, Kun Bo Park, Hyun Woo Kim, Soon Hyuck Lee, Ha Yong Kim, Soon Chul Lee, Changhoon Jeong, Moon Seok Park, Won Joon Yoo, Chin Youb Chung, In Ho Choi, Ok-Hwa Kim, Woong-Yang Park & Tae-Joon Cho. (2016) Comprehensive genetic exploration of skeletal dysplasia using targeted exome sequencing. Genetics in Medicine 18:6, pages 563-569.
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Jonathan C. Barone, Katsuyuki Saito, Karl Beutner, Maria Campo, Wei Dong, Chirayu P. Goswami, Erica S. Johnson, Zi-Xuan Wang & Susan Hsu. (2015) HLA-genotyping of clinical specimens using Ion Torrent-based NGS. Human Immunology 76:12, pages 903-909.
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