GENEWIZ from Azenta | GLP-compliant SNP Mutation Analysis

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} .ngs-content-box button { border: none; border-radius: 4px; background: #826ec3; padding: 10px 20px; color: #fff; font-size: 17px; letter-spacing: 1px; } .ngs-content-box button:hover { background: #6965a1; } @media only screen and (max-width: 991px) { .headline-center { padding-top: 0; } .ngs-new-container { text-align: center; margin-top: 0; } .ngs-new-content { width: 90%; margin: 0 auto; } .ngs-new-content { display: inline-block; } #ngs-content-box-right, #ngs-content-box-left { width: 100%; text-align: center; } #ngs-content-box-right { margin-top: 20px; } } @media only screen and (max-width: 1170px) { .ngs-new-content { width: 90%; margin: 0 auto; } .ngs-content-box img { width: 350px; } } </style> <div class="ngs-new-container"> <div class="ngs-new-content"> <div class="ngs-content-box" id="ngs-content-box-left"> <h1>GLP-COMPLIANT SNP/MUTATION ANALYSIS</h1> <div> </div> <p>GENEWIZ SNP/Mutation Analysis from Azenta Life Sciences is designed to follow Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) as applicable to our services, and Good Clinical Practice (GCP) guidelines. Validate diagnostic assays with confidence and detect genetic mutations accurately, empowering you to achieve clinical success.</p> <p> </p> <a rel="noopener noreferrer" href="https://clims4.genewiz.com/DynamicForm/CreateView?lobId=9&serviceId=904" target="_blank"><button>Request Quote</button> </a></div> <a rel="noopener noreferrer" target="_blank"> </a> <div class="ngs-content-box" id="ngs-content-box-right"><a rel="noopener noreferrer" target="_blank"> </a><a rel="noopener noreferrer" rel="noopener noreferrer" href="https://web.azenta.com/glp-aav-itr-sequencing?__hstc=251210969.ee677d8374177d47808d4f65f2e7a318.1652957843001.1665750180820.1665994413146.206&__hssc=251210969.23.1665994413146&__hsfp=1345237511" target="_blank"><img alt="" src="/-/media/Images/16011-D_GLP-AAV-ITR_WebBanRight.ashx?la=en&hash=EBEA872320CFE1CBCDF06FA6298754E739FC41D3" /></a> </div> </div> </div> </div> <div class="headline-center Rich-Text-Edit-Area"> <style type="text/css"> @import url('https://fonts.googleapis.com/css?family=Roboto:300,400,500,700'); body { margin: 0; border: 0; padding: 0; } .sanger-plasmid-prep-banner { width: 100%; height: 120px; background: #62b864; text-align: left; margin-top: -50px; } .sanger-plasmid-prep-banner-content { width: 1170px; margin: 0 auto; } .sanger-plasmid-prep-box { display: inline-block; vertical-align: middle; } .sanger-plasmid-prep-box h2 { font-family: 'Roboto', sans-serif; color: #fff; text-transform: none; letter-spacing: 1px; padding-top: 45px; border-bottom: none; font-size: 20px; font-weight: 700; } #sanger-plasmid-prep-box-image { width: 10%; text-align: right; } #sanger-plasmid-prep-box-left { width: 65%; margin-left: 15px; } #sanger-plasmid-prep-box-right { text-align: right; width: 15%; } #sanger-plasmid-prep-box-left p { font-family: 'Roboto', sans-serif; font-size: 14px; font-weight: 500; letter-spacing: 2px; color: #fff; } #sanger-plasmid-prep-box-right button { padding: 15px 25px 15px 25px; color: #0067B1; font-size: 14px; font-weight: bold; letter-spacing: 1px; background: #fff; border: none; transition: all .2s ease-in-out; } #sanger-plasmid-prep-box-right button:hover { cursor: pointer; transform: scale(1.1); } #sanger-plasmid-prep-box-right button:focus { outline: 0; } </style> <div class="container"> <h2>REGULATORY SNP DETECTION AND MUTATION ANALYSIS</h2> <p style="text-align: left;"> Azenta can sequence and analyze your clinical trial samples or confirm your diagnostic assay results according to FDA and EPA GLP standards. Simply provide SNP IDs, genes, or sequences of interest and Azenta can design, develop, and optimize your assays. Azenta’s experienced scientists and Quality Assurance Unit will ensure your assays are processed and reported according to the applicable regulatory standards. </p> <p style="text-align: left;"> </p> <p style="text-align: left;"> </p> <h2>DIAGNOSTIC KIT AND MEDICAL DEVICE ASSAY VALIDATION</h2> <p>Assay validation services for diagnostic kit and medical device 510k and PMA submissions are available at the GLP-compliant level. <br /> For more information, please email <a href="mailto:regulatory@azenta.com">regulatory@azenta.com</a>.</p> </div> <br /> </div> <div class="headline-center Rich-Text-Edit-Area"> <link href="https://fonts.googleapis.com/css?family=Roboto:300,400,500,700" rel="stylesheet" /> <style type="text/css"> .covid-banner { width: 1170px; height: auto; margin: 0 auto; background-image: url("/-/media/11036-D_Plasmid-ONT_WebBanFull-Med_Background.ashx"); background-size: cover; background-position: center; text-align: left; padding: 0px 0 0px 0; } .covid-content { 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<div class='Component-Frame pull-center Multi-column-TextBullet-Layout Component-BackGround-Default margin-top-0 margin-bottom-30 padding-top-10 padding-bottom-10'> <div class="container"> <div class="headline-center"> <h2>Features & Benefits</h2> </div> <div class="headline-left"> </div> <div class="row category"> <div class="col-md-6 col-sm-6"> <div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <p><strong>Complete Solution</strong></p> <ul> <li>Nucleic acid extraction services</li> <li>SNP (single nucleotide polymorphisms) and mutation assay development</li> <li>Dedicated Study Director</li> <li>Detailed Study Report including description of methods, list of SOPs, raw data, and detailed results</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <p><strong>State-of-the-Art, Dedicated GLP Laboratories</strong></p> <ul> <li>FDA and EPA GLP-compliant, reliable services</li> <li>Controlled facility, sample, personnel, process, and documents</li> <li>Follows GMP (as applicable to our services) and GCP guidelines</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <p><strong>Outsource to the Industry Leader in Sanger Sequencing</strong></p> <ul> <li>Developed and documented processes</li> <li>Qualified instruments</li> <li>Trained personnel</li> <li>Dedicated, state-of-the-art regulatory laboratory</li> <li>Thorough quality assurance program save you time, reagents, paperwork</li> </ul> </div> </div> </div> <div class="col-md-6 col-sm-6"> <div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <p><strong>Established <a href="/en/Public/Resources/Quality-Management-System">Quality Management System</a></strong></p> <ul> <li>Quality Assurance Unit oversight</li> <li>Azenta is available for audits</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <p><strong>Proprietary Protocols</strong></p> <ul> <li>Complete sequencing, even in regions with high GC content</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <p><strong>Superior Support</strong></p> <ul> <li>Dedicated Study Director ensures a single point of contact</li> <li>Expert technical support</li> <li>Consistent, transparent communication</li> </ul> </div> </div> </div> </div> </div> </div><div class="process-v1 Image-Slider Component-BackGround-Default margin-top-0 margin-bottom-30 padding-top-10 padding-bottom-30"> <div class="container"> <div class="headline-center margin-bottom-20"> <div class="row"> <h2>GLP-Compliant SNP/Mutation Analysis Process</h2> </div> <div class="row"> <h4><br></h4> </div> </div> <ul class="list-inline list-st row process-in headline-center"> <li style="text-align:center;cursor:pointer;" class="ImgSlili_1"> <div class="row headline-center"> <img src="/-/media/Images/Services/GLP/workflow/SNP/assay-design.ashx?h=110&la=en&w=210&hash=F8FD245DBCB54C774683885AC35CD20ABCF97612" alt="" width="210" height="110" /> </div> <div class="row headline-center"> <h3>Assay Design</h3> <br><br> </div> <div class="SeqIcon SeqIcon_1"> <span class="SeqIcon_text">1</span> </div> </li> <li style="vertical-align:bottom;text-align:center;opacity:1" class="Img-arror Img_1"> <img src="/-/media/Gwz/arrow.ashx?h=50&la=en&w=70&hash=E9EE43042F03F59D57F7E4676486569A4310720A" alt="arrow" width="70" height="50" /> </li><li style="text-align:center;cursor:pointer;" class="ImgSlili_2"> <div class="row headline-center"> <img src="/-/media/Images/Services/GLP/workflow/SNP/sample-processing.ashx?h=110&la=en&w=210&hash=C2BF4FC08BB0E15E3123B0EA682880CBFC2C49B5" alt="" width="210" height="110" /> </div> <div class="row headline-center"> <h3>Sample<br /> Processing</h3> <br /> </div> <div class="SeqIcon SeqIcon_2"> <span class="SeqIcon_text">2</span> </div> </li> <li style="vertical-align:bottom;text-align:center;opacity:1" class="Img-arror Img_2"> <img src="/-/media/Gwz/arrow.ashx?h=50&la=en&w=70&hash=E9EE43042F03F59D57F7E4676486569A4310720A" alt="arrow" width="70" height="50" /> </li><li style="text-align:center;cursor:pointer;" class="ImgSlili_3"> <div class="row headline-center"> <img src="/-/media/Images/Services/GLP/workflow/SNP/data-analysis-reporting.ashx?h=110&la=en&w=210&hash=A70B501AE1B83AB8959EEFC9F74479E461D8A756" alt="" width="210" height="110" /> </div> <div class="row headline-center"> <h3>Data Analysis & Reporting</h3><p><br></p> </div> <div class="SeqIcon SeqIcon_3"> <span class="SeqIcon_text">3</span> </div> </li> <li style="vertical-align:bottom;text-align:center;opacity:1" class="Img-arror Img_3"> </li> </ul> <div class="row icon-content content_1"> <div class="col-sm-10"> <span>Primers and conditions are optimized to the target region(s) of interest. Study Protocol and SOPs are utilized in compliance with GLP regulations.</span> </div> </div><div class="row icon-content content_2"> <div class="col-sm-10"> <span>Sample preparation, amplification, and sequencing of target region(s). GENEWIZ network of quality oversight ensures compliance with GLP regulations.</span> </div> </div><div class="row icon-content content_3"> <div class="col-sm-10"> <span>Data quality review and detailed Study Report outlining methods used, results, compliance statement, and quality oversight inspection dates, results in Quality Assurance of each Study according to GLP regulations. </span> </div> </div> </div> <script language="javascript" type="text/javascript"> var i = 1; var iconCount = 0; var icons; var iconContent; var Flag; jQuery(document).ready(function ($) { icons = $(".SeqIcon"); iconContent = $(".icon-content"); //hide the content if (iconContent != null && jQuery(".content_1").length > 0) { iconContent.each(function (i) { if (i > 0) { $(this).hide(); } }); } //change the icon status if (icons != null) { iconCount = icons.length; $(icons[0]).addClass("SeqIcon_Sel"); Flag = setInterval(function () { if (i == iconCount) { i = 0; } SwcRCA(i); i++; }, 2000); } $("li[class^=ImgSlili]").bind("mousemove", function () { clearInterval(Flag); jQuery("div[class^='row icon-content content_']").hide(); jQuery(".Img-arror").find("img").attr("src", "/assets/img/gwz/arrow.png"); jQuery(icons).removeClass("SeqIcon_Sel"); jQuery(".content_" + $(this).attr("class").split("_")[1]).show(); jQuery(icons[$(this).attr("class").split("_")[1] - 1]).addClass("SeqIcon_Sel"); jQuery(".Img_" + $(this).attr("class").split("_")[1]).find("img").attr("src", "/assets/img/gwz/arrow_sel.png"); }); $("li[class^=ImgSlili]").bind("mouseleave", function () { i = 0; Flag = setInterval(function () { SwcRCA(i); i++; }, 2000); jQuery(icons[$(this).attr("class").split("_")[1] - 1]).removeClass("SeqIcon_Sel"); jQuery(".Img_" + $(this).attr("class").split("_")[1]).find("img").attr("src", "/assets/img/gwz/arrow.png"); }); }); function SwcRCA(i) { if (i == 0) { jQuery(icons[icons.length - 1]).removeClass("SeqIcon_Sel"); } else { jQuery(icons[i - 1]).removeClass("SeqIcon_Sel"); } jQuery("div[class^='row icon-content content_']").hide(); jQuery(icons[i]).addClass("SeqIcon_Sel"); jQuery(".content_" + (i + 1)).show(); //change the arrow color jQuery(".Img_" + (i)).find("img").attr("src", "/assets/img/gwz/arrow.png"); if (i != (icons.length - 1)) { jQuery(".Img_" + (i + 1)).find("img").attr("src", "/assets/img/gwz/arrow_sel.png"); } } </script> </div> <div class="process-v1 How-To-Order Component-BackGround-Gray margin-top-0 padding-top-10 padding-bottom-10 "> <div class=" container"> <div class="headline-center"> <div class="row"> <h2>How to Order</h2> </div> <div class="row"> *Samples must arrive at the GENEWIZ New Jersey Laboratory before 10:00 am EST to qualify for Same Day service. Note that direct-sequencing templates are not available for our Same Day service.<br /> </div> </div> <ul class="list-inline row process-in process-border-3 col-xs-offset-0"> <li class="col-sm-3"> <div class="process-icon"> <i class="rounded-x dot-active"></i> </div> <a href='/Public/Resources/Sample-Submission-Guidelines' target='_blank'> <div class="process-desc"> <img src="/-/media/Images/Home/icons/Purple-Icons/prepare-samples_90x90_Purple.ashx?h=90&la=en&w=90&hash=D5B4727E901955084F0BAAA98461174597484501" alt="Building" width="90" height="90" /> </div> <div class="row"> <h3>Prepare Samples</h3> </div> </a> </li><li class="col-sm-3"> <div class="process-icon"> <i class="rounded-x dot-active"></i> </div> <a href='/Public/Resources/Sample-Submission-Guidelines' target='_blank'> <div class="process-desc"> <img src="/-/media/Images/Home/icons/Purple-Icons/submit-samples-to-GENEWIZ_90x90_Purple.ashx?h=90&la=en&w=90&hash=00BB21EF13939D24F31645E3B03BBBBCCAA466E7" alt="Building" width="90" 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