GENEWIZ | Clinical Services FAQs

<!DOCTYPE html>    <html lang="en">  <head> <title>GENEWIZ | Clinical Services FAQs</title>  <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=edge,chrome=1"> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <meta name="description" content="GENEWIZ CLIA services frequently asked questions including pcr, Sanger sequencing, and next generation sequencing."> <meta name="keywords" content="clinical, clia, cap, pcr, sanger, ngs, exome sequencing, whole genome sequencing, clinical laboratory improvement amendments, clia workflow, clia environment, clia-validated"> <meta name="author" content="">  <link rel="shortcut icon" href="favicon.png">   <link rel="stylesheet" href="/assets/plugins/bootstrap/css/bootstrap.min.css"> <link rel="stylesheet" href="/assets/css/style.css?v=1"> <link rel="stylesheet" href="/assets/css/custom.css?v=1"> <link rel="canonical" href="https://www.genewiz.com/Public/Resources/FAQs/FAQs-Clinical-Services/" /> <link rel="alternate" hreflang="x-default" href="https://www.genewiz.com/Public/Resources/FAQs/FAQs-Clinical-Services" /> <link rel="alternate" hreflang="en-us" href="https://www.genewiz.com/Public/Resources/FAQs/FAQs-Clinical-Services" /> <link rel="alternate" hreflang="en-us" href="https://www.genewiz.com/en/Public/Resources/FAQs/FAQs-Clinical-Services" /> <link rel="alternate" hreflang="en-GB" href="https://www.genewiz.com/en-GB/Public/Resources/FAQs/FAQs-Clinical-Services" /> <script type="text/javascript" src="/sitecore/shell/controls/lib/prototype/prototype.js"></script> <script type="text/javascript" src="/assets/plugins/jquery/jquery.min.js"></script> <script type="text/javascript"> var jQuery = $; //if (window.location.search.indexOf("sc_mode=edit") > 0) { jQuery.noConflict(); //} </script> <script type="text/javascript" src="/assets/plugins/bootstrap/js/bootstrap.min.js"></script> <script type="text/javascript" src="/assets/plugins/back-to-top.js"></script> <script type="text/javascript" src="/assets/js/app.js"></script>   <script> (function (w, d, s, l, i) { w[l] = w[l] || []; w[l].push( { 'gtm.start': new Date().getTime(), event: 'gtm.js' } ); var f = d.getElementsByTagName(s)[0], j = d.createElement(s), dl = l != 'dataLayer' ? 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href='/en/Public/Services/Next-Generation-Sequencing/RNA-Seq' style='color:#585F69;font-size:14px'>RNA-Seq</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Proteomics' style='color:#585F69;font-size:14px'>Proteomics</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/High-Throughput-Gene-Expression-Screening' style='color:#585F69;font-size:14px'>High-Throughput Gene Expression Screening <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Single-Cell-Sequencing' style='color:#585F69;font-size:14px'>Single-Cell Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Exome-Sequencing' style='color:#585F69;font-size:14px'>Exome Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Amplicon-Sequencing-Services' style='color:#585F69;font-size:14px'>Amplicon Sequencing Services</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Standalone-NGS-Solutions' style='color:#585F69;font-size:14px'>Sequencing Only<br></a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Whole-Genome-Sequencing' style='color:#585F69;font-size:14px'>Whole Genome Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/High-Throughput-Genotyping' style='color:#585F69;font-size:14px'>CRISPR Validation</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Targeted-Resequencing-Panels' style='color:#585F69;font-size:14px'>Targeted Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Metagenomics-Solutions' style='color:#585F69;font-size:14px'>Metagenomics </a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Epigenomics' style='color:#585F69;font-size:14px'>Epigenomics</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Antibody-Discovery' style='color:#585F69;font-size:14px'>Antibody Discovery <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Immunogenomics' style='color:#585F69;font-size:14px'>Immunogenomics</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Digital-Spatial-Profiling' style='color:#585F69;font-size:14px'>Digital Spatial Profiling</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/AAV-Genome-Sequencing' style='color:#585F69;font-size:14px'>AAV Genome Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Whole-Plasmid-Sequencing-Plasmid-EZ' style='color:#585F69;font-size:14px'>Whole Plasmid Sequencing: Plasmid-EZ <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Sanger-Sequencing' style='color:#826ec3;font-size:17px'>Sanger Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Sanger-EZ' style='color:#585F69;font-size:14px'>Sanger-EZ <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Sanger-Sequencing/AAV-ITR' style='color:#585F69;font-size:14px'>AAV-ITR Sanger Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Purified-Templates' style='color:#585F69;font-size:14px'>Purified Templates</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Difficult-Template-Sequencing' style='color:#585F69;font-size:14px'>Difficult Template Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Direct-Colony-Sequencing' style='color:#585F69;font-size:14px'>Direct Colony Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/PCR-Purification' style='color:#585F69;font-size:14px'>PCR Purification</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Primer-Walking' style='color:#585F69;font-size:14px'>Primer Walking</a></li><br><li><a class='GColor' href='/en/Public/Services/Molecular-Genetics' style='color:#826ec3;font-size:17px'>PCR + Sanger Services</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Bacterial-and-Fungal-Identification' style='color:#585F69;font-size:14px'>Bacterial and Fungal Identification</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Mutation-Analysis' style='color:#585F69;font-size:14px'>Mutation Analysis</a></li><li><a href='/en/Public/Services/Molecular-Genetics/SNP-Genotyping' style='color:#585F69;font-size:14px'>SNP Genotyping</a></li><li><a href='/en/Public/Services/Molecular-Genetics/PCR-Plus-Sequencing-CRISPR-Analysis-Package' style='color:#585F69;font-size:14px'>PCR Plus Sequencing CRISPR Analysis Package</a></li><li><a href='/en/Public/Services/Molecular-Genetics/cDNA-Verification' style='color:#585F69;font-size:14px'>Confirmatory Sequencing & Cell Bank Characterization</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Yeast-Colony-Sequencing' style='color:#585F69;font-size:14px'>Yeast Colony Sequencing</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Fragment-Analysis' style='color:#585F69;font-size:14px'>Fragment Analysis</a></li><li><a href='/en/Public/Services/Molecular-Genetics/PCR-Solutions' style='color:#585F69;font-size:14px'>Quantitative PCR & Digital PCR <sup style="color:#826ec3;"><strong>NEW </strong></sup></a></li><li><a href='/en/Public/Services/Molecular-Genetics/Nucleic-Acid-Extraction' style='color:#585F69;font-size:14px'>Nucleic Acid Extraction</a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Gene-Synthesis' style='color:#826ec3;font-size:17px'>DNA & RNA Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Gene-Synthesis' style='color:#585F69;font-size:14px'>Gene Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Antibody-DNA-Synthesis' style='color:#585F69;font-size:14px'>Antibody Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/AAV-Plasmid-Synthesis' style='color:#585F69;font-size:14px'>AAV Plasmid Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Gene-Fragments' style='color:#585F69;font-size:14px'>Gene Fragments</a></li><li><a href='/en/Public/Services/Gene-Synthesis/CRISPR-Construct-Synthesis' style='color:#585F69;font-size:14px'>CRISPR Construct Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Synthetic-DNA-Libraries' style='color:#585F69;font-size:14px'>Synthetic DNA Libraries</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Single-Stranded-DNA-Synthesis' style='color:#585F69;font-size:14px'>ssDNA Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/DNA-Cloning' style='color:#585F69;font-size:14px'>DNA Cloning</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Site-Directed-Mutagenesis' style='color:#585F69;font-size:14px'>Site-Directed Mutagenesis<br></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Viral-Package' style='color:#585F69;font-size:14px'>Viral Packaging <sup style="color:#826ec3;"><strong>NEW </strong></sup></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Recombinant-Antibody-Production' style='color:#585F69;font-size:14px'>Recombinant Antibody Production <sup style="color:#826ec3;"><strong>NEW </strong></sup></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Custom-mRNA-Synthesis' style='color:#585F69;font-size:14px'>Custom mRNA Synthesis <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><br><li><a class='GColor' href='/en/Public/Services/Oligo' style='color:#826ec3;font-size:17px'>Oligo Synthesis Services</a></li><li><a href='/en/Public/Services/Oligo/Overnight-DNA-Oligos' style='color:#585F69;font-size:14px'>Overnight DNA Oligos</a></li><li><a href='/en/Public/Services/Oligo/Custom-DNA-and-RNA-Oligos' style='color:#585F69;font-size:14px'>Custom DNA and RNA Oligos</a></li><li><a href='/en/Public/Services/Oligo/Oligo-Retained-for-Sanger-Sequencing' style='color:#585F69;font-size:14px'>Oligo Retained for Sanger Sequencing</a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Plasmid-DNA-Prep' style='color:#826ec3;font-size:17px'>Plasmid DNA Preparation</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/Standard' style='color:#585F69;font-size:14px'>Standard Plasmid DNA Prep</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/Targeted-Yield' style='color:#585F69;font-size:14px'>Targeted Yield Plasmid DNA Prep</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/AAV-Plasmid-Preparation' style='color:#585F69;font-size:14px'>AAV Plasmid Preparation</a></li><br><li><a class='GColor' href='/en/Public/Services/Clinical-Services' style='color:#826ec3;font-size:17px'>PreClinical and Clinical Services</a></li><li><a href='/en/Public/Services/Clinical-Services/Clinical-Services-Overview' style='color:#585F69;font-size:14px'>Clinical Services</a></li><li><a href='/en/Public/Services/Clinical-Services/Microarray-Solutions' style='color:#585F69;font-size:14px'>Microarray Solutions <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Variant-Confirmation' style='color:#585F69;font-size:14px'>CLIA Variant Confirmation (PCR + Sanger)</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Sanger-Sequencing' style='color:#585F69;font-size:14px'>CLIA Sanger Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Whole-Exome-Sequencing' style='color:#585F69;font-size:14px'>CLIA Whole Exome Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Whole-Genome-Sequencing' style='color:#585F69;font-size:14px'>CLIA Whole Genome Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/Regulatory' style='color:#585F69;font-size:14px'>GLP-Compliant Overview</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-Confirmatory-Sequencing' style='color:#585F69;font-size:14px'>GLP Confirmatory Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-SNP-Mutation-Analysis' style='color:#585F69;font-size:14px'>GLP SNP Mutation Analysis</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-Plasmid-Prep' style='color:#585F69;font-size:14px'>GLP Plasmid Prep</a></li><li><a href='/en/Public/Services/Clinical-Services/Nucleic-Acid-Extraction' style='color:#585F69;font-size:14px'>GLP Nucleic Acid Extraction</a></li><li><a href='/en/Public/Services/Clinical-Services/Biofluid-Processing-Overview' style='color:#585F69;font-size:14px'>Biofluid Processing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Integration-Site-Analysis' style='color:#585F69;font-size:14px'>CLIA Integration Site Analysis <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li></ul></div></div></div></li></ul></li><li class='dropdown'><a href='/en/Public/Research-Areas' data-toggle='dropdown' class='dropdown-toggle' style='color:white;height:52px;top:47px;padding-top:0;background-color:transparent;font-size:17px;font-weight:bold;'>RESEARCH AREAS</a><ul class='dropdown-menu'><li class='dropdown'><a class='GColor' href='/en/Public/Research-Areas/AAV' style='font-size:17px'>AAV Services</a><ul class='dropdown-menu'></ul></li><li class='dropdown'><a class='GColor' href='/en/Public/Research-Areas/Agriculture-Food-Science' style='font-size:17px'>Agriculture and Food Science</a><ul class='dropdown-menu'></ul></li><li class='dropdown'><a class='GColor' href='https://web.azenta.com/cell-and-gene-therapy' style='font-size:17px'>Cell and Gene Therapy Solutions 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Antibody Synthesis </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/AAV-Plasmid-Synthesis'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/GWZ_NGS_WGS_Web_Icon_Purple.ashx?h=111&la=en&w=211&hash=575FF0ADB583ABD8C22E3A9657928E65B4D56174" alt="RNA Seq" width="211" height="111" /> </div> <div class="row headline-center"> AAV Plasmid Synthesis </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/Gene-Fragments'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/Fragment-Gene_Web-Icon-Service_Purple_DESIGN.ashx?h=111&la=en&w=211&hash=8B6C44621515B4D66E237B533867CEBF28597388" alt="" width="211" height="111" /> </div> <div class="row headline-center"> Gene Fragments </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/CRISPR-Construct-Synthesis'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/CRISPR_Icon_Purple.ashx?h=331&la=en&w=631&hash=541C101EA97AEBCA8EA962D36AD2922CB35FE460" alt="crispr construct" width="631" height="331" /> </div> <div class="row headline-center"> CRISPR Construct Synthesis </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/Single-Stranded-DNA-Synthesis'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/ssDNA_110x210_Purple.ashx?h=110&la=en&w=210&hash=57E43E64A21720B80BF2A5746483D5BBBB17A254" alt="" width="210" height="110" /> </div> <div class="row headline-center"> ssDNA Synthesis </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/DNA-Cloning'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/cloning_110x210_Purple.ashx?h=110&la=en&w=210&hash=5F857E11BC24AF4E76D2A29E7A4704BDE297B307" alt="" width="210" height="110" /> </div> <div class="row headline-center"> DNA Cloning </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/Site-Directed-Mutagenesis'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/mutagenesis_110x210_Purple.ashx?h=110&la=en&w=210&hash=738C433B319554ECF88933576FF0816CFCEDDEE2" alt="" width="210" height="110" /> </div> <div class="row headline-center"> Site-Directed Mutagenesis<br> </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/Viral-Package'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Lentivirus-Packaging-Purple---Viral-packaging.ashx?h=505&la=en&w=505&hash=5B796283B0454DE108B6C7D977BB10EC52633DE8" alt="" width="505" height="505" /> </div> <div class="row headline-center"> Viral Packaging <sup style="color:#826ec3;"><strong>NEW </strong></sup> </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/Recombinant-Antibody-Production'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Antibody-Services.ashx?h=204&la=en&w=247&hash=0CF3B7E0147E6E5EC28A2B034181B0255773B79E" alt="" width="247" height="204" /> </div> <div class="row headline-center"> Recombinant Antibody Production <sup style="color:#826ec3;"><strong>NEW </strong></sup> </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Gene-Synthesis/Custom-mRNA-Synthesis'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Antibody-Services.ashx?h=204&la=en&w=247&hash=0CF3B7E0147E6E5EC28A2B034181B0255773B79E" alt="" width="247" height="204" /> </div> <div class="row headline-center"> Custom mRNA Synthesis <sup style="color:#826ec3; font-weight: bold;">NEW</sup> </div> </div> </div> </div> </div> </li> </ul> </li> <li class="dropdown mega-menu-fullwidth"> <a href="/en/Public/Services/Oligo" class="dropdown-toggle" data-toggle="dropdown" style="color: #585f69;padding-left:5px;padding-right:5px;top:20px; font-size:11px;"> Oligo Synthesis Services </a> <ul class="dropdown-menu"> <li> <div class="mega-menu-content disable-icons"> <div class="container"> <div class="row "> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Oligo/Overnight-DNA-Oligos'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/oligo-rapid-210_Purple.ashx?h=110&la=en&w=210&hash=590094F4AFF45814A7315E8AF6D90CD13DD66370" alt="Oligo Synthesis" width="210" height="110" /> </div> <div class="row headline-center"> Overnight DNA Oligos </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Oligo/Custom-DNA-and-RNA-Oligos'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/oligo---Custom_Purple.ashx?h=110&la=en&w=210&hash=0C8C3A8EFB03837C2E5E39464569FC44FF912567" alt="Oligo Synthesis" width="210" height="110" /> </div> <div class="row headline-center"> Custom DNA and RNA Oligos </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Oligo/Oligo-Retained-for-Sanger-Sequencing'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/oligo-overview_110x210_Purple.ashx?h=110&la=en&w=210&hash=8DE6E33AFFEDA659BD0739BDF0B5C1A000F5555B" alt="Oligo Synthesis" width="210" height="110" /> </div> <div class="row headline-center"> Oligo Retained for Sanger Sequencing </div> </div> </div> </div> </div> </li> </ul> </li> <li class="dropdown mega-menu-fullwidth"> <a href="/en/Public/Services/Plasmid-DNA-Prep" class="dropdown-toggle" data-toggle="dropdown" style="color: #585f69;padding-left:5px;padding-right:5px;top:20px; font-size:11px;"> Plasmid DNA Preparation </a> <ul class="dropdown-menu"> <li> <div class="mega-menu-content disable-icons"> <div class="container"> <div class="row "> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Plasmid-DNA-Prep/Standard'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/plasmid-prep-overview_110x210_Purple.ashx?h=110&la=en&w=210&hash=D542B9BF1106F547CB84A8011F635AD43B95653A" alt="" width="210" height="110" /> </div> <div class="row headline-center"> Standard Plasmid DNA Prep </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Plasmid-DNA-Prep/Targeted-Yield'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/light-blue-targeted-yield-prep_110_Purple.ashx?h=111&la=en&w=210&hash=877C30C274AC7E0625DFF49201FF41E769C9D62D" alt="" width="210" height="111" /> </div> <div class="row headline-center"> Targeted Yield Plasmid DNA Prep </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Plasmid-DNA-Prep/AAV-Plasmid-Preparation'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/AAV_Prep_Service_Icon_Purple.ashx?h=100&la=en&w=110&hash=AD8BA067F9561F24A7F70BB7314C04B99ABBE3EA" alt="" width="110" height="100" /> </div> <div class="row headline-center"> AAV Plasmid Preparation </div> </div> </div> </div> </div> </li> </ul> </li> <li class="dropdown mega-menu-fullwidth"> <a href="/en/Public/Services/Clinical-Services" class="dropdown-toggle" data-toggle="dropdown" style="color: #585f69;padding-left:5px;padding-right:5px;top:20px; font-size:11px;"> PreClinical and Clinical Services </a> <ul class="dropdown-menu"> <li> <div class="mega-menu-content disable-icons"> <div class="container"> <div class="row "> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/Clinical-Services-Overview'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> Clinical Services </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/Microarray-Solutions'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> Microarray Solutions <sup style="color:#826ec3; font-weight: bold;">NEW</sup> </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/CLIA-Variant-Confirmation'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> CLIA Variant Confirmation (PCR + Sanger) </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/CLIA-Sanger-Sequencing'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> CLIA Sanger Sequencing </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/CLIA-Whole-Exome-Sequencing'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> CLIA Whole Exome Sequencing </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/CLIA-Whole-Genome-Sequencing'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> CLIA Whole Genome Sequencing </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/Regulatory'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/GLP-compliant-Confirmatory-Sequencing_110x210_Purple.ashx?h=110&la=en&w=210&hash=6E17481E2B90ACF9B7789BF343BD5E801683A447" alt="" width="210" height="110" /> </div> <div class="row headline-center"> GLP-Compliant Overview </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/GLP-compliant-Confirmatory-Sequencing'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/GLP-compliant-Confirmatory-Sequencing_110x210_Purple.ashx?h=110&la=en&w=210&hash=6E17481E2B90ACF9B7789BF343BD5E801683A447" alt="" width="210" height="110" /> </div> <div class="row headline-center"> GLP Confirmatory Sequencing </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/GLP-compliant-SNP-Mutation-Analysis'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/GLP-compliant-SNP-Mutation-Analysis_110x210_Purple.ashx?h=110&la=en&w=210&hash=FEC877C60D6900DA782A8BA4A89823B016285E0F" alt="" width="210" height="110" /> </div> <div class="row headline-center"> GLP SNP Mutation Analysis </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/GLP-compliant-Plasmid-Prep'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/GLP-compliant-plasmid-prep_110x210_Purple.ashx?h=110&la=en&w=210&hash=50C0A6163387BD975BB09982BC5B1DBDCFCD5404" alt="" width="210" height="110" /> </div> <div class="row headline-center"> GLP Plasmid Prep </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/Nucleic-Acid-Extraction'"> <div class="row headline-center margin-bottom-10"> <img src="/-/media/Images/Home/icons/Purple-Icons/Nucleic-Acid-Extraction_110x210_Purple.ashx?h=110&la=en&w=210&hash=9C72E25F36E011F6ACD2D7CFB169F12713A6596D" alt="" width="210" height="110" /> </div> <div class="row headline-center"> GLP Nucleic Acid Extraction </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/Biofluid-Processing-Overview'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> Biofluid Processing </div> </div> <div class="col-md-3" style="cursor:pointer;padding-top:20px;padding-bottom:20px;" onclick="location.href = '/en/Public/Services/Clinical-Services/CLIA-Integration-Site-Analysis'"> <div class="row headline-center margin-bottom-10"> </div> <div class="row headline-center"> CLIA Integration Site Analysis <sup style="color:#826ec3; font-weight: bold;">NEW</sup> </div> </div> </div> </div> </div> </li> </ul> </li> </ul> </div> </div> </div> </div>  </div>  <br /><br /> <div class="headline-center Rich-Text-Edit-Area"> <style> .anchor{ display: block; height: 176px; margin-top: -176px; visibility: hidden; } </style> <div class="container"> <br /> <br /> <br /> <h1>Clinical Services FAQs</h1> <br /> <br /> <ul class="list-inline"> <li> <h3><a href="#CLIA-WGS-WES-FAQs" class="blue-text">CLIA Whole Genome Sequencing and Whole Exome Sequencing</a> </h3> </li> | <li> <h3><a href="#CLIA-PCR-SANGER-FAQs" class="blue-text">CLIA PCR and Sanger Sequencing</a> </h3> </li> | <li> <h3><a href="#CLIA-Integration-Site-Analysis-FAQs" class="blue-text">CLIA Integration Site Analysis (ISA)</a> </h3> </li> | <li> <h3><a href="#Microarray-FAQs" class="blue-text">Microarray Solutions</a> </h3> </li> </ul> </div> </div> <div class="container FAQs"> <div class="row"> <span id="CLIA-WGS-WES-FAQs" class="anchor"></span><h3>CLIA Whole Genome Sequencing and Whole Exome Sequencing <br /></h3> </div> <div class="row"> <div class="NoBorder panel-group acc-v1 container" id='CLIA-WGS-WES-FAQs'> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--1" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is the difference between "CLIA-Validated Service" and "CLIA Environment" service levels?</div> </a> </div> <div id="QA--1" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> The only difference is that CLIA-Validated Service includes a Lab Director Signature and QA Oversight whereas CLIA Environment does not. In addition, the CLIA Environment service level allows greater flexibility in experimental design, such as custom starting materials, and offers a range of sequencing coverage options. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--2" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Do you provide RUO whole exome sequencing?</div> </a> </div> <div id="QA--2" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Yes, we do. <a href="https://web.genewiz.com/ngs-clims4" target="_blank">Click here</a> to request a quote. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--3" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is the advantage of exome sequencing compared to whole genome sequencing?</div> </a> </div> <div id="QA--3" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <p>Whole genome sequencing requires an extremely high amount of sequencing throughput to generate a moderate depth of coverage. The data generated, while comprehensive, does not allow detection of mutations with as much sensitivity as a targeted approach. Exome sequencing is the most cost-effective and efficient solution.</p> <p>A large portion of relevant mutations occur in the exome. In fact, the exome contains as many as 85% of disease-related mutations. Covering less than 2% of the whole genome, exome sequencing requires only 1/50th of the sequencing throughput to generate the same depth of coverage. This approach provides flexible experimental options:<br /> <ul> <li>Maintain the same depth of coverage and multiplex more samples into the same sequencing lane, significantly decreasing total project cost</li> <li>Increase the depth of coverage to facilitate the detection of rare, low-frequency mutation</li> </ul> </p> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--4" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>How much coverage do I need? </div> </a> </div> <div id="QA--4" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> The answer depends on the goals of your sequencing project. Our CLIA-Validated service is only available with ~50x coverage, which is ideal for germline variant detection. In contrast, our CLIA Environment service provides a wide range of coverage options to meet your needs for a variety of applications, as outlined below: <ul> <li>Germline/frequent variants: 50-100x</li> <li>Somatic/rare variants: ≥200x</li> <li>Tumor vs Normal: ≥200x tumor, ≥100x normal</li> <li>Population studies: 50-100x</li> </ul> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--5" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What bioinformatics analysis is available?</div> </a> </div> <div id="QA--5" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> We provide raw data as FASTQ files for all projects. We also offer mapping and variant calling through BAM and VCF files, respectively. Please note that no variant annotation or interpretation is offered at this time. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--6" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>How do I contact Azenta for a technical consultation about my project?</div> </a> </div> <div id="QA--6" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Azenta‘s CLIA team is composed of Ph.D. scientists who can help you optimize your project design and provide consultation to answer any questions. For any form questions that require support, please contact the CLIA team at <a href="mailto:CLIA@azenta.com">CLIA@Azenta.com</a>, toll-free at 877-436-3949 ext. 1, or directly at +1-908-222-0711 ext. 1. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--7" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Why choose Azenta for exome sequencing projects?</div> </a> </div> <div id="QA--7" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> We have proven our steadfast commitment to superior service throughout the years, becoming established as a global leader in DNA sequencing and genomics. Further, we have extensive experience and expertise in next generation sequencing techniques, including population-scale sequencing. Our CLIA NGS services build upon our RUO services, utilizing the same optimized workflows but within a CLIA-certified and CAP-accredited laboratory. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-WGS-WES-FAQs" href="#QA--8" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Is your laboratory CLIA-certified?</div> </a> </div> <div id="QA--8" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Yes, our laboratory is both CLIA-certified and CAP-accredited. Our CLIA and CAP license numbers are 31D2038673 and 8015683, respectively. </div> </div> </div> </div> </div> </div><div class="container FAQs"> <div class="row"> <span id="CLIA-PCR-SANGER-FAQs" class="anchor"></span><h3>CLIA PCR and Sanger Sequencing<br></h3> </div> <div class="row"> <div class="NoBorder panel-group acc-v1 container" id='CLIA-PCR-SANGER-FAQs'> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---1" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is CLIA PCR and Sanger Sequencing?</div> </a> </div> <div id="QA---1" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> CLIA PCR and Sanger Sequencing is PCR and Sanger sequencing processed in a CLIA-licensed/CAP-accredited laboratory. All work is performed under a CLIA-compliant workflow that utilizes CLIA-trained personnel on CLIA-qualified equipment. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---2" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Is Azenta CLIA licensed?</div> </a> </div> <div id="QA---2" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Yes, Azenta is licensed by CMS (Centers for Medicare and Medicaid Services) under the Clinical Laboratory Improvement Amendments of 1998 as qualified to perform high complexity clinical laboratory testing. Azenta holds clinical lab licenses from NJ, PA, CA, RI and MD. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---3" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Is Azenta CAP-accredited?</div> </a> </div> <div id="QA---3" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Yes, Azenta is CAP (College of American Pathologists) accredited.  </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---4" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is the difference between CLIA Environment, CLIA Workflow, and CLIA full service options?</div> </a> </div> <div id="QA---4" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Choose “CLIA Environment” if you need CLIA lab, CLIA personnel, CLIA workflow, without QA oversight or lab director (Azenta does not make claims to the clinical significance of the data). <br /> <br /> Choose “CLIA Workflow” if you need CLIA lab, CLIA personnel, CLIA workflow, QA oversight, assay performed in triplicate at the assay development stage, no test registration, no clinical outcome reporting, and lab director signature to ensure CLIA-compliant sequencing. This uses the workflow and activities of the validated CLIA test but does not use a registered test from the test roster. <br /> <br /> Choose “CLIA” if you need CLIA lab, CLIA personnel, CLIA workflow, QA oversight, assay validation (to assess accuracy, sensitivity, reproducibility), test registration, clinical outcome reporting, and lab director signature. <br /> <br /> <a rel="noopener noreferrer" href="https://www.genewiz.com/en/Public/Services/Clinical-Services/CLIA-Variant-Confirmation" target="_blank">Click here</a> for a visual summary of CLIA Environment, CLIA Workflow, and CLIA full service. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---5" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Do you have pre-developed assays available to order?</div> </a> </div> <div id="QA---5" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Please email <a href="mailto:Regulatory@azenta.com">Regulatory@azenta.com</a> to discuss further. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---6" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Do you accept any sample type other than genomic DNA?</div> </a> </div> <div id="QA---6" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Please email <a href="mailto:Regulatory@azenta.com">Regulatory@azenta.com</a> to discuss sample acceptance criteria. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---7" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Can I provide a custom target sequence?</div> </a> </div> <div id="QA---7" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Please email <a href="mailto:Regulatory@azenta.com">Regulatory@azenta.com</a> to discuss PCR assay design. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---8" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is different between your standard PCR and Sanger sequencing and CLIA PCR and Sanger sequencing?</div> </a> </div> <div id="QA---8" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> CLIA Sanger sequencing is performed in the CLIA-certified/CAP-accredited laboratory by CLIA-trained personnel on CLIA-qualified equipment. Sample and reagent tracking for each order with a review of the final documentation by Quality Assurance and our lab director is also provided. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---9" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What are the deliverables from a CLIA PCR and Sanger sequencing order?</div> </a> </div> <div id="QA---9" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> You will receive the original sequencing results in a chromatogram (.ab1 files), the sequence files (.seq files), and the quality files (.phd files) along with a quality report which contains the quality score and contiguous read length per trace. For an additional fee, you can request a lab director signed report which will indicate that the order was processed within a CLIA-compliant workflow. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---10" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div><p id="CLIA" style="color:gray;">What does the variant analysis report include?</p></div> </a> </div> <div id="QA---10" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> This report includes the exact nucleotide base calls for any mutations found within the region of interest. Two-fold sequencing is necessary to obtain this report. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---11" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Do you offer a lab director signed report?</div> </a> </div> <div id="QA---11" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Yes, you can request a lab director signed report which will indicate that the order was processed within a CLIA-compliant workflow for an additional fee per trace. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-PCR-SANGER-FAQs" href="#QA---12" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Do you offer CLIA standalone Sanger sequencing?</div> </a> </div> <div id="QA---12" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Yes, please see the service offerings <a href="https://www.genewiz.com/en/Public/Services/Clinical-Services/CLIA-Sanger-Sequencing" target="_blank">here</a>. </div> </div> </div> </div> </div> </div><div class="container FAQs"> <div class="row"> <span id="CLIA-Integration-Site-Analysis-FAQs" class="anchor"></span> <h3>CLIA Integration Site Analysis (ISA)</h3> </div> <div class="row"> <div class="NoBorder panel-group acc-v1 container" id='CLIA-Integration-Site-Analysis-FAQs'> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----1" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What kind of sample type(s) do you accept and what are the sample requirements?</div> </a> </div> <div id="QA----1" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <span style="color: black;">Azenta Life Sciences, formerly GENEWIZ, can accept sample types from which</span><span style="color: black;"> high-quality </span><span style="color: black;">genomic DNA </span><span style="color: black;">(gDNA) </span><span style="color: black;">can be extracted. We have extensive experience working with all sample types including </span><span style="color: black;"><strong>cells, cell pellets, PBMCs, whole blood, and fresh frozen tissue</strong>. </span><span style="color: black;">The sample requirements for the most common sample types are > 500 ng for genomic DNA and 10-30 mg of fresh frozen tissue.</span> <style type="text/css"> a {text-decoration: none; cursor: pointer;} .title h1 { font-size: 20px; text-align: center; } .table { margin-top: 20px; } td { vertical-align: middle; } </style> <div class="container title">  </div> <div class="table"> <div class="col-md-9 col-centered"> <table class="table table-responsive table-bordered"> <tbody class="panel panel-purple"> <tr class="panel-heading"> <td>Sample Type</td> <td>Quantity</td> </tr> <tr> <td style="text-align:left; vertical-align: top;">Cells</td> <td style="text-align: left; vertical-align: top;">1 million</td> </tr> <tr> <td style="text-align:left; vertical-align: top;"> gDNA</td> <td style="text-align: left; vertical-align: top;"> > 500 ng</td> </tr> <tr> <td style="text-align:left; vertical-align: top;"> Fresh frozen tissues </td> <td style="text-align: left; vertical-align: top;"> 10-30 mg</td> </tr> </tbody> </table> </div> </div> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----2" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What assays does Azenta use for Integration Site Analysis?</div> </a> </div> <div id="QA----2" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">We offer two analytically validated NGS-based assays, leveraging targeted approaches to identify, quantify, and monitor viral vector integration events across the genome. Both assays generate information on insertion site location and frequency as well as offer the following unique capabilities:</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;"><strong>Target Enrichment Sequencing </strong></span><span style="color: black;"><strong>(TES)</strong> </span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">A </span><span style="color: black;">Hybridization-Capture</span><span style="color: black;"> TES </span><span style="color: black;">Assay </span><span style="color: black;">that</span><span style="color: #70ad47;"> </span><span style="color: black;">generates information on insertion site location and frequency, and additionally allows for insertion/transgene integrity study, which is important to resolve mutations or rearrangements.</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;"><strong>Quantitative Shearing Linear Amplification Mediated-PCR (</strong></span><strong><span style="color: black;">qsLAM</span><span style="color: black;">-PCR)</span></strong></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">A Targeted </span><span style="color: black;">qsLAM</span><span style="color: black;">-PCR Sequencing Assay </span><span style="color: black;">that </span><span style="color: black;">focuses on identifying insertion site location and frequency, offering superior sensitivity on insertion site detection.</span></p> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----3" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What are the highlights of your assays for Integration Site Analysis?</div> </a> </div> <div id="QA----3" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">Both </span><span style="color: black;">of our analytically validated NGS-based </span><span style="color: black;">assays are efficient at generating information about where the viral vector has inserted into the host genome</span><span style="color: black;">:</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;"><strong>Linear Amplification-Mediated-PCR (LAM-PCR)</strong> </span><span style="color: black;">focuses on insertion site location and frequency, offering superior sensitivity on insertion site detection; </span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;"><strong>Hybrid Capture Targeted Enrichment Sequencing (TES)</strong> </span><span style="color: black;">generates information on insertion site location and frequency, and additionally allows for insertion/transgene integrity study, which is important to resolve mutations or rearrangements.</span></p> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----4" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is the turnaround time?</div> </a> </div> <div id="QA----4" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <span style="color: black;">Standard </span><span style="color: black;">turnaround time </span><span style="color: black;">is 3-4 weeks</span><span style="color: black;">; </span><span style="color: black;">Expedited options are also available. </span> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----5" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is the importance/significance of identifying viral integration sites after administration of cell or gene therapies? Is it required by regulatory agencies?</div> </a> </div> <div id="QA----5" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">Lentiviral vectors are efficient gene delivery vehicles suitable for delivering long-term transgene expression in various cell types over time. A drawback of the lentiviral vector include the risk of insertional mutagenesis due to the sem</span><span style="color: black;">i-r</span><span style="color: black;">andom integration of genes. </span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">Guidance from the FDA and other regulatory authorities, is that patients treated with cell or gene therapies utilizing viral vectors be monitored for 5 - 15 years for safety. This monitoring includes, but not limited to, vector integration studies of patient samples to ensure stability.</span></p> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----6" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What are Long Term Follow Up studies and how are Integration Studies associated?</div> </a> </div> <div id="QA----6" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">Per the FDA, "LTFU observations are extended assessments that continue some of the scheduled observations of a clinical trial past the active follow-up period and are an integral portion of the study of some investigational GT products.  LTFU observations are important to monitor long term safety of GT products.  For GT products that present long term risks to subjects, LTFU/surveillance plan(s) should also be put in place post-licensure for monitoring of delayed adverse events (for details we refer you to section VI. of this document)." </span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">Guidelines from the FDA suggest 15 years of long-term follow up after gene therapy treatment with integrating vectors such as lentiviral vectors. Analysis should be performed to determine the site of vector integration if the analysis of a subject’s surrogate cells suggests a predominant clone (e.g., oligoclonal pattern of vector insertions) or monoclonality. In addition, if you detect a predominant integration site, test for persistence by performing another analysis for clonality no more than three months later.</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">Source: </span><span style="color: black;"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/long-term-follow-after-administration-human-gene-therapy-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/long-term-follow-after-administration-human-gene-therapy-products</a></span></p> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----7" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is the importance of doing longitudinal clonal expansion analysis?</div> </a> </div> <div id="QA----7" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <span style="color: black;">Lentiviral vectors are well known for their ability to effectively deliver genetic material for long-term transgene expression over time. There is also potential for unintended consequences resulting from random viral integrations into the host genome. Azenta has developed detection methods to study clonal outgrowths of transduced cell populations after gene therapy administration.</span> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----8" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Why is it important to perform oncogenic gene annotation of Integration Site?</div> </a> </div> <div id="QA----8" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <span style="color: black;">When lentiviral integration happens near oncogenes or within key genes, it may affect important cellular functions. For this reason, it is important to identify the exact site(s) of integration in target cells, post-infection. The selected integration site has important consequences for both the expression of the transgene and the phenotype of the host cell.</span> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#CLIA-Integration-Site-Analysis-FAQs" href="#QA----9" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What is included in the ISA report deliverables?</div> </a> </div> <div id="QA----9" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <span style="color: black;"></span> <br> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">1) Insertion </span><span style="color: black;">site location, frequency, abundance</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">2) Integration hotspots & CPG islands</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">3) Oncogenic gene annotation of Integration Site</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">4) </span><span style="color: black;">Longtitudinal</span><span style="color: black;"> profiling (clonal expansion)</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">5) Vector </span><span style="color: #70ad47;">i</span><span style="color: black;">ntegrity (TES)</span></p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"> </p> <p style="margin-top: 0pt; margin-bottom: 0pt; margin-left: 0in; text-align: left;"><span style="color: black;">Custom analysis support options are also available upon consultation.</span></p> </div> </div> </div> </div> </div> </div><div class="container FAQs"> <div class="row"> <span id="Microarray-FAQs" class="anchor"></span> <h3>Microarray Solutions</h3> </div> <div class="row"> <div class="NoBorder panel-group acc-v1 container" id='Microarray-FAQs'> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#Microarray-FAQs" href="#QA-----1" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What are relevant microarray applications?</div> </a> </div> <div id="QA-----1" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Microarrays offer a high throughput technology to examine genotyping, gene expression, and/or methylation data for samples. Targets are printed or synthesized on a solid substrate, which is interrogated by a probe derived from samples of interest. Detection is typically done using a high-density scanner after hybridization and staining. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#Microarray-FAQs" href="#QA-----2" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>How do ThermoFisher and Illumina microarrays differ?</div> </a> </div> <div id="QA-----2" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <ul> <li>ThermoFisher manufactures microarrays by synthesizing targets in situ. Arrays are offered in a 96-well plate and may contain 800,000+ targets in each well. Microarrays are scanned on a ThermoFisher GeneTitan instrument with analysis using the Axiom Analysis Suite Software. ThermoFisher offers microarrays for genotyping and gene expression analysis.</li> <li>Illumina utilizes silica microbeads adorned with hundreds of thousands to millions of genotypes. These beads are housed in etched microwells and coated with multiple copies of an oligonucleotide probe targeting a specific genomic locus. The beads contain one extra base which enables incorporation of a labeled nucleotide, which can be detected on Illumina’s iScan instrument, and analyzed using GenomeStudio software. Illumina offers bead chip arrays for genotyping or methylation analysis.</li> </ul> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#Microarray-FAQs" href="#QA-----3" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>What samples can be accepted for microarray analysis?</div> </a> </div> <div id="QA-----3" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> We can accept many sample types, including, but not limited to, whole blood, PBMCs, tissue, saliva, FFPE blocks or curls, laser microdissections, or extracted nucleic acids (DNA or RNA). </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#Microarray-FAQs" href="#QA-----4" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>How many samples can be processed per plate or bead chip?</div> </a> </div> <div id="QA-----4" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <ul> <li>For ThermoFisher Axiom arrays, 96 samples are genotyped per plate. For ThermoFisher GO Screen (gene expression) arrays, 384 samples are processed per plate.</li> <li>For Illumina bead chip arrays, the number of samples depends on the bead chip array of interest. Typically, these are processed as 8, 16, 24, 32, or 96 samples.</li> </ul> Kindly note that for either microarray supplier, you will be charged for a full plate/bead chip, including all necessary controls. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#Microarray-FAQs" href="#QA-----5" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>At what regulatory oversight is our microarray service offered?</div> </a> </div> <div id="QA-----5" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Our microarray service is offered at a regulatory level appropriate for exploratory research. This offers quality oversight in a regulated environment consisting of instrument maintenance and calibration logs, reagent lot tracking, staff training logs, chain-of-custody audit trails, IT systems maintenance and back-up logs, and the ability to audit the facility and process. Note that we can offer this as a clinically validated service; please <a href="mailto:clia@azenta.com">inquire</a> for additional details. </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#Microarray-FAQs" href="#QA-----6" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>Do we incorporate positive and negative controls?</div> </a> </div> <div id="QA-----6" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> <ul> <li>ThermoFisher microarrays: Both positive (HapMap) and negative (no template) controls, provided by ThermoFisher, are used in the Axiom (genotyping) arrays. For a ThermoFisher Axiom array (96-wells), only 94 samples are available for customer samples as 2 positions are required for these controls. For ThermoFisher GO Screen (384-wells), one NTC and one positive control are used per plate.</li> <li>Illumina bead chips: A single positive control, provided by Illumina, is used per run, regardless of the number of bead chips in the run. </li> </ul> </div> </div> </div> <div class="NoBorder panel panel-default"> <div class="panel-heading SingleBorder" style="text-align:left;"> <a class="accordion-toggle" data-toggle="collapse" data-parent="#Microarray-FAQs" href="#QA-----7" style="color:gray;text-align:left;"> <div class="QA col-sm-1">Q:</div> <div>May we set up a teleconference to discuss our project’s needs?</div> </a> </div> <div id="QA-----7" class=" panel-collapse collapse NoBorder"> <div class="panel-body NoBorder"> <div class="QA col-sm-1">A:</div> Yes, please email <a href="mailto:clia@azenta.com">clia@azenta.com</a> and we’d be delighted to arrange a meeting to consult about the details of your project with one of our PhD-level study managers. </div> </div> </div> </div> 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