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the Pitfalls of Diagnostic Assay Development</span></div></div></header> <section class="hero-banner" style="background-image:url(https://www.thermofisher.com/blog/oempowered/wp-content/uploads/sites/21/2023/03/Blog-13_Pittfalls-for-Assay-Developers_HERO-IMAGE.jpg)"> </section> <div class="site-inner"><div class="content-sidebar-wrap"><main class="content"><article class="post-490 post type-post status-publish format-standard has-post-thumbnail category-partnership tag-assay-development tag-audible-blog tag-customization tag-diagnostic-assay tag-diagnostic-assay-development tag-manufacturing tag-molecular-diagnostic-assay tag-oem tag-oem-partner tag-reagents entry" aria-label="How to Avoid the Pitfalls of Diagnostic Assay Development"><header class="entry-header"><h1 class="entry-title">How to Avoid the Pitfalls of Diagnostic Assay Development</h1> <span class="post-info-author"> By <a href="https://www.thermofisher.com/blog/author/juliafletcher/" title="Posts by Julia Fletcher" rel="author">Julia Fletcher</a> </span> <span class="post-info-date"> 03.09.2023 </span> </header><div class="entry-content"> <table id="amazon-polly-audio-table"> <tr> <td id="amazon-polly-audio-tab"> <div id="amazon-ai-player-label">You can now learn on the go. Click play to listen to this blog:</div> <div id="amazon-ai-player-container"> <audio class="amazon-ai-player" id="amazon-ai-player" preload="none" controls > <source type="audio/mpeg" src="https://s3.us-east-1.amazonaws.com/audio-for-wordpress-59302176961bdae8c67016437ea35f5b41607042/2023/03/amazon_polly_490.mp3?version=1679082699"> </audio> </div> <div id="amazon-polly-subscribe-tab"></div> <div id="amazon-polly-by-tab"></div> </td> </tr> </table><h2>Start assay development with an OEM partner to help avoid these four common pitfalls</h2> <p>The <a href="https://oem.thermofisher.com/?utm_source=COL024371&utm_medium=Blog&utm_campaign=Consideration&utm_content=bp13" target="_blank" rel="noopener">OEM and Commercial Supply Team</a> at Thermo Fisher Scientific specializes in working with diagnostic assay development clients who need help turning their scientific ideas into concrete scientific solutions.</p> <p>The following story of Maya is a representative character used to illustrate real assay development pitfalls and highlight four areas where an OEM partner can provide expertise to complement scientific passion.</p> <h3>This time it was going to be different</h3> <p>Maya was a teenager when she lost her mom to breast cancer. The loss of her mom inspired Maya to become a scientist because she saw firsthand the need for better cancer treatments. Maya knew her mom would be proud of her becoming the lead of her company’s new oncology assay development program.</p> <p>It took two years to address the issues that delayed the validation of the company’s latest <a href="https://www.cancer.gov/news-events/cancer-currents-blog/2017/liquid-biopsy-detects-treats-cancer" target="_blank" rel="noopener">liquid biopsy assay</a>. As a research and development team member, Maya learned that great science is only part of what brings a successful diagnostic assay to market after meeting regional regulatory requirements.</p> <p>Even the most passionate scientists can miss small details that can derail assay development timelines. Early choices made in the assay design phase can make big differences in outcomes down the road.</p> <p>Leading the project that could improve the cancer diagnosis and monitoring that took her mom was important to Maya. She was going to make sure not to repeat the missteps that delayed the last project. This time it was going to be different.</p> <p>Maya planned to avoid the following four common assay development pitfalls by bringing in the right expertise at the start.</p> <h3>Pitfall 1:</h3> <h4>Don’t begin feasibility/proof of concept with suboptimal reagents. The quality of the reagents matter.</h4> <p>During the last project, the nucleic acid extraction buffer that worked best during feasibility started failing when scaled up in assay development. The team determined that one of the buffer reagents contained a contaminant that interfered with DNA amplification.</p> <p>The team investigated further and found that the failing reagent didn’t meet certain quality limits after reviewing its <a href="https://www.gmp-compliance.org/gmp-news/gmp-requirements-for-certificates-of-analysis-coa" target="_blank" rel="noopener">certificate of analysis (CofA)</a>. The inexpensive reagent was never an issue in smaller-scale experiments so reviewing the CofA didn’t seem relevant.</p> <p>Maya wanted to think long-term when planning feasibility/proof of concept testing for the new assay. Reagent costs are important but so is time lost to troubleshoot when a component isn’t the right quality.</p> <p>To kick-off her assay development program she was going to identify reagent suppliers who were willing to work with her team from <a href="https://www.thermofisher.com/blog/oempowered/nine-questions-oem-partner/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" target="_blank" rel="noopener">start-to-finish</a>. Off-the-shelf reagents don’t always meet stringent specifications.</p> <p>Maya wanted to make sure <a href="https://www.thermofisher.com/blog/oempowered/four-things-about-customized-oem-solutions/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" target="_blank" rel="noopener">customized solutions</a> were available to help ensure the new assay’s successful commercialization.</p> <h3>Pitfall 2:</h3> <h4>A limited supply chain can delay commercialization</h4> <p>Six months before the expected launch of her company’s liquid biopsy assay, Maya learned that one of the biomarker probe suppliers notified the team of a raw material shortage. Luckily, the shortage only delayed the shipment of the assay by two weeks.</p> <p>The scare had the team revisiting primary supply agreements and realizing that not having a <a href="https://www.thermofisher.com/blog/oempowered/why-secondary-sourcing/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" target="_blank" rel="noopener">secondary supplier</a> in place for the probes was a big risk.</p> <p>Maya planned to compare reagent suppliers during the new assay design process. She wanted to have a plan B in place from the beginning especially for key assay components. A top priority was to find an OEM partner that could help <a href="https://www.thermofisher.com/blog/oempowered/right-oem-partner-supply-chain-security/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" target="_blank" rel="noopener">secure a consistent reagent supply chain</a>.</p> <h3>Pitfall 3:</h3> <h4>Underestimating the transition to manufacturing</h4> <p>Locking the final design of a diagnostic assay is a great achievement, but unforeseen hurdles are bound to arise once assay verification and validation (V&V) begins. Maya experienced one such hurdle during her last assay development program.</p> <p>The standard operating procedures (SOPs) for performing the assay validation were in place, but a regulatory review found that the manufacturing team mis-calibrated a critical instrument.</p> <p>The fallout from the instrument mis-calibration didn’t lead to inaccurate test results. However, Maya’s company received a regulatory warning letter to revise several operational SOPs to avoid future compliance issues.</p> <p>For her new program, Maya had the green light to secure a trusted OEM manufacturer to speed up the assay development. Any OEM partner she considered would need to have a global footprint and practice stringent quality control standards such as <a href="https://www.iso.org/iso-13485-medical-devices.html" target="_blank" rel="noopener">ISO 13495</a> and <a href="https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps" target="_blank" rel="noopener">cGMP</a>.</p> <h3>Pitfall 4:</h3> <h4>Don’t wait to find support to help with regulatory requirements</h4> <p>Maya’s company already had a certified quality management system (QMS). Even with a certified QMS in place, regulatory agencies like the <a href="https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation" target="_blank" rel="noopener">Food and Drug Administration (FDA)</a> or the <a href="https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices" target="_blank" rel="noopener">European Medicines Agency (EMA)</a> make periodic updates to diagnostic assay regulatory requirements to address changes in technologies and standards.</p> <p>The European Union (EU) <a href="https://www.thermofisher.com/blog/oempowered/three-steps-you-can-take-to-navigate-the-ivdr/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" target="_blank" rel="noopener">In-Vitro Medical Diagnostic Regulation (IVDR) classification</a> challenged the team. The last assay program followed the previous <a href="https://www.thermofisher.com/blog/oempowered/ivdd-vs-ivdr-classifications-defined-and-compared/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" target="_blank" rel="noopener">In Vitro Diagnostic Medical Device Directive (IVDD)</a>. Regulatory clearance took much longer because of the required updates to manufacturing and quality-control process assessments.</p> <p>Maya was going to bring in a regulatory consultant at the start for the new assay design. The eyes of a regulatory expert are helpful at every stage of the diagnostic assay development process. Maya was not a regulatory expert and wanted to focus on scientific innovation.</p> <h2>Start with the right OEM partner to help avoid the common pitfalls of assay design</h2> <p>The <a href="https://oem.thermofisher.com/?utm_source=COL024371&utm_medium=Blog&utm_campaign=Consideration&utm_content=bp13" target="_blank" rel="noopener">OEM and Commercial Supply Team</a> at Thermo Fisher Scientific helps scientists like Maya convert their scientific passion into concrete scientific solutions. The right OEM partner helps remove common assay design pitfalls.</p> <p>Our comprehensive menu of custom manufacturing options and services includes <a href="https://www.thermofisher.com/blog/oempowered/three-custom-lyo-solutions/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" target="_blank" rel="noopener">customized reagents</a>, professional supply agreements, high quality manufacturing facilities, and extensive expertise in regulatory requirements.</p> <p>Maya learned the key to success is to bring in an OEM partner from the beginning.</p> <p>Make the first step of your diagnostic assay development a connection with one of our OEM business development and alliance managers. Our team leverages a world leader in science to help take you where you need to go.</p> <p> </p> <div class="btn btn-featured" style="background-image: linear-gradient(to bottom, #ee3134, #ee3134);width: 250px;border-radius: 0 !important;padding: 11px 19px;font-size: 17.94px;line-height: 22px;text-align: center;vertical-align: middle;border: 1px solid #dd1f25;color: #ffffff;font-weight: normal;text-decoration: none;margin: auto"><a style="color: #ffffff" title="Connect with us" href="https://www.thermofisher.com/us/en/home/global/forms/life-science/oem-contact.html?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_lgn_og_s00_FormCTA" target="_blank" rel="noopener">Connect with us</a></div> <p> </p> <p> </p> <h2>Related Links & Resources</h2> <ul> <li>Learn more: <a href="https://oem.thermofisher.com/?utm_source=COL024371&utm_medium=Blog&utm_campaign=Consideration&utm_content=bp13" target="_blank" rel="noopener">Genetic Sciences OEM and Commercial Supply</a></li> <li>Article: <a title="Important Questions to Ask When Considering an OEM Partner" href="https://www.thermofisher.com/blog/oempowered/nine-questions-oem-partner/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" rel="noopener">Nine Questions to Ask When Considering an OEM Partner</a></li> <li>Article: <a href="https://www.thermofisher.com/blog/oempowered/four-things-about-customized-oem-solutions/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog">Four Things You Should Know About Customized OEM Solutions</a></li> <li>Article: <a href="https://www.thermofisher.com/blog/oempowered/why-secondary-sourcing/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" rel="noopener">Why Secondary Sourcing Should Be Your Primary Plan</a></li> <li>Article: <a title="Successful Companies Rely on OEM Partners to Ensure Supply Chain Security" href="https://www.thermofisher.com/blog/oempowered/right-oem-partner-supply-chain-security/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog">How to Help Ensure Your Supply Chain Security</a></li> <li>Article: <a href="https://www.thermofisher.com/blog/oempowered/three-steps-you-can-take-to-navigate-the-ivdr/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog">Three Steps You Can Take to Navigate the IVDR</a></li> <li>Article: <a href="https://www.thermofisher.com/blog/oempowered/ivdd-vs-ivdr-classifications-defined-and-compared/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog">IVDD vs. IVDR: Classifications Defined and Compared</a></li> <li>Article: <a title="Important Questions to Ask When Considering an OEM Partner" href="https://www.thermofisher.com/blog/oempowered/three-custom-lyo-solutions/?cid=gsd_cdi_lcs_r01_co_cp1508_pjt8733_col024371_0so_blg_il_edu_og_s00_RelatedBlog" rel="noopener">Three Custom Lyophilization Solutions to OEMpower Molecular Assay Development</a></li> <li>Reference: <a href="https://www.cancer.gov/news-events/cancer-currents-blog/2017/liquid-biopsy-detects-treats-cancer" target="_blank" rel="noopener">Liquid Biopsy: Using DNA in Blood to Detect, Track, and Treat Cancer</a></li> <li>Reference: <a href="https://www.gmp-compliance.org/gmp-news/gmp-requirements-for-certificates-of-analysis-coa">GMP Requirements for Certificates of Analysis (CoA)</a></li> <li>Reference: <a href="https://www.iso.org/iso-13485-medical-devices.html">ISO 13485 – Medical devices</a></li> <li>Reference: <a href="https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps">Facts About the Current Good Manufacturing Practices (CGMPs) | FDA</a></li> <li>Reference: <a href="https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation">Overview of IVD Regulation | FDA</a></li> <li>Reference: <a href="https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices">Medical devices | European Medicines Agency (europa.eu)</a></li> <li><a title="With an OEM partnership, what used to be impossible becomes OEM-possible" href="https://www.thermofisher.com/blog/oempowered/">←Back to OEMpowered Blog</a></li> </ul>  </div></article> <div id="respond" class="comment-respond"> <h3 id="reply-title" class="comment-reply-title">Leave a Reply <small><a rel="nofollow" id="cancel-comment-reply-link" href="/oempowered/pitfalls-of-assay-development/#respond" style="display:none;">Cancel reply</a></small></h3><form action="https://www.thermofisher.com/blog/oempowered/wp-comments-post.php" method="post" id="commentform" class="comment-form" novalidate><p class="comment-notes"><span id="email-notes">Your email address will not be published.</span> <span class="required-field-message">Required fields are marked <span class="required">*</span></span></p><p 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