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if(isHidden(s)){ s.style.display = 'inline'; } else { s.style.display = 'none'; } } function isHidden(element){ var style = window.getComputedStyle(element); return (style.display === 'none'); } </script> <span class="cc_sidebar"> <span class="cc_color_bar"> <span class="cc_home_icon"> <a href="https://www.thermofisher.com/blog/clinical-conversations/"><img src="https://www.thermofisher.com/blog/clinical-conversations/wp-content/themes/clinical-conversations/images/icon_home.png" alt="Clinical Conversation blog - home icon" /></a> </span> <span class="cc_post_category"> <a class='cc_colorbar_category' href='https://www.thermofisher.com/blog/clinical-conversations/category/case-studies/'>Case studies</a> </span>  <span id="cc_post_readtime"> 4 mins. </span> <span class="cc_toggle_social"> <a href="javascript:cc_toggle('cc_jetpack_shares');">Sharing ▼</a> </span> <span class="cc_toggle"> <a href="javascript:cc_toggle('cc_metadata');">Details ▼</a> </span> </span> </span> <span id="cc_jetpack_shares"> <ul> <li><a target="_blank" href='https://www.linkedin.com/shareArticle?mini=true&url=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fwebinar-overview-challenges-of-establishing-laboratory-developed-tests%2F&title=Webinar+Overview%3A+Challenges+of+Establishing+Laboratory+Developed+Tests'><img src="https://www.thermofisher.com/blog/clinical-conversations//wp-content/themes/clinical-conversations/images/social_icons_linkedin.jpg" alt="Linked In sharing icon" /></a></li> <li><a target="_blank" href='https://www.facebook.com/sharer/sharer.php?u=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fwebinar-overview-challenges-of-establishing-laboratory-developed-tests%2F'><img src="https://www.thermofisher.com/blog/clinical-conversations//wp-content/themes/clinical-conversations/images/social_icons_facebook.jpg" alt="Facebook sharing icon" /></a></li> <li><a target="_blank" href='https://twitter.com/intent/tweet?text=Webinar+Overview%3A+Challenges+of+Establishing+Laboratory+Developed+Tests&url=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fwebinar-overview-challenges-of-establishing-laboratory-developed-tests%2F&'><img src="https://www.thermofisher.com/blog/clinical-conversations//wp-content/themes/clinical-conversations/images/social_icons_twitter.jpg" alt="Twitter sharing icon" /></a></li> <li><a href='mailto:?subject=You might be interested in Webinar Overview: Challenges of Establishing Laboratory Developed Tests from the Clinical Conversations blog.&body=You might be interested in Webinar Overview: Challenges of Establishing Laboratory Developed Tests from the Clinical Conversations blog at https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fwebinar-overview-challenges-of-establishing-laboratory-developed-tests%2F'><img src="https://www.thermofisher.com/blog/clinical-conversations/wp-content/themes/clinical-conversations/images/icon_email.png" alt="Email sharing icon" /></a></li> </ul> </span> <span id="cc_metadata"> <span class="cc_dateline"> <span class="post-info-date">  14 Dec 2021 </span> || <span class="post-info-author">   By Manoj Gandhi, M.D., Ph.D. </span> </span> <span class="cc_shares"> <span class="cc_shares_subhead" >Shares: <span class="share_count">3</span> </span> </span> <span class="cc_version"> <span class="cc_version_subhead">Versions of this article</span> Original article. </span> <span class="cc_post_tags"> <span class="cc_post_tags_subhead">Tags</span> <a href='https://www.thermofisher.com/blog/clinical-conversations/tag/covid-19/'>COVID-19</a>, <a href='https://www.thermofisher.com/blog/clinical-conversations/tag/ldt/'>LDT</a>, <a href='https://www.thermofisher.com/blog/clinical-conversations/tag/pcr/'>PCR</a> </span>   </span> <script type="text/javascript"> cc_toggle('cc_metadata'); cc_toggle('cc_jetpack_shares'); </script> </header><div class="entry-content"><p class="selectionShareable" data-uw-styling-context="true">Historically, developing a molecular test within a clinical laboratory has been perceived as a complicated and laborious process. This webinar from the 2021 Lab Compliance Connect virtual event aims to dispel common misconceptions of Laboratory Developed Tests (LDTs) by inviting Dr. Vijay Singh, Director of Molecular Diagnostics at HealthTrackRx, to share the advantages, challenges, and considerations he encounters while designing and implementing molecular tests at his laboratory, which specializes in infectious disease testing. To set the stage, he addresses the three basic questions:</p> <ul> <li data-uw-styling-context="true">What is an LDT?</li> <li data-uw-styling-context="true">Why are LDTs needed?</li> <li data-uw-styling-context="true">How are LDTs established?</li> </ul> <p class="selectionShareable" data-uw-styling-context="true">Understanding the regulatory requirements and guiding principles for setting test characteristics and laboratory practices established by authorities such as the FDA, CAP, CLSI, CLIA, and local state laws can be a daunting first step. A successful LDT needs a clear and well-planned strategy for establishing the following performance characteristics required by CLIA: reportable range, analytical sensitivity, analytical specificity, precision, accuracy, and reference interval.</p> <p><iframe title="Challenges of Establishing Laboratory Developed Tests" width="760" height="428" src="https://www.youtube.com/embed/2oMeZVitYhc?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe></p> <h2 data-uw-styling-context="true">Determining the right testing strategy: a business decision</h2> <p class="selectionShareable" data-uw-styling-context="true">Dr. Singh stresses the importance of determining a testing strategy not only as a scientific exercise, but as a business decision very early in the planning process. Leveraging the knowledge of experienced test manufacturers or assay developers in designing an optimized workflow can save time and headaches. A streamlined workflow can minimize wasted resources, while maximizing information and revenue for the patient and provider. Resource planning is important for every step of the RT-PCR workflow, particularly those where automation is deemed advantageous. Notably, one of the most challenging “stumbling blocks” for any LDT is identifying and banking samples to use as reference material for the validation studies, which can be facilitated upon early collaboration with the test manufacturer, hospitals, and/or clinics.</p> <h2 data-uw-styling-context="true">The HealthTrackRx experience and COVID-19</h2> <p class="selectionShareable" data-uw-styling-context="true" data-uw-rm-mod="">HealthTrackRx is a PCR-based infectious disease laboratory, advancing healthcare through decentralized patient-directed testing, large-scale surveillance pathogen testing, antimicrobial stewardship, and value-based care programs. HealthTrackRx’s 2018 experience launching large multiplex syndromic panels enabled them to quickly develop and launch their second-generation RT-PCR based LDT when the COVID-19 pandemic hit in 2020. Planning is difficult and performing all the required studies is very hard work. By committing ample resources to planning for the COVID-19 LDT, HealthTrackRx was able to conduct all the development work in only 10 days. The hard work is paying off; within 17 months they have run nearly 2 million COVID-19 tests.</p> <p class="selectionShareable" data-uw-styling-context="true">The strategy to generate the maximum amount of clinically actionable information with reasonable cost and profits saved time and money for HealthTrackRx and their patients, who ultimately benefit by receiving better clinical decisions. The patient’s interest should always be at the center of every decision when establishing an LDT, using the basic principles of Good Laboratory Practices as a guide. Working closely with test developers can streamline the LDT development process while maintaining regulatory compliance.</p> <p class="selectionShareable" data-uw-styling-context="true">After this webinar, attendees will be able to:</p> <ul> <li data-uw-styling-context="true">Describe advantages of implementing a laboratory developed test</li> <li data-uw-styling-context="true">List decision criteria for assay design and target selection</li> <li data-uw-styling-context="true">Recall analytical and clinical validation considerations</li> </ul> <p class="selectionShareable" data-uw-styling-context="true">Be sure to watch this informative webinar to hear Dr. Singh’s personal experiences and reflections of what it takes for a clinical laboratory to bring an in-house molecular test to market.</p> <p class="selectionShareable" data-uw-styling-context="true">Also, don’t miss out on “<a href="https://www.thermofisher.com/us/en/home/global/forms/life-science/business-lab-developed-tests.html?icid=_gsd_gts_pjt7618_colchallengesblog_BLG_TXT_LDT_0723" data-uw-styling-context="true" data-uw-rm-brl="false">An introduction to diagnostic testing in laboratories</a>”, published by the College of Health Solutions, Arizona State University. This educational paper provides in-depth information supported by meaningful examples of LDTs and their different applications.</p> <p data-uw-styling-context="true"><strong>Explore additional educational content: </strong></p> <p data-uw-styling-context="true">Blog: <a href="https://www.thermofisher.com/blog/clinical-conversations/7-things-to-know-before-establishing-an-ldt?icid=_gsd_gts_pjt7618_colchallengesblog_BLG_TXT_LDT_0723">7 things to know before establishing an LDT</a><br /> Paper: <a href="https://www.thermofisher.com/us/en/home/global/forms/life-science/regulatory-guidance-diagnostic-tests.html?icid=_gsd_gts_pjt7618_colchallengesblog_BLG_TXT_LDT_0723">Regulatory guidance for laboratories that design and implement diagnostic tests for clinical use</a><br /> Paper: <a href="https://www.thermofisher.com/us/en/home/global/forms/life-science/diagnostic-test-reimbursement.html?icid=_gsd_gts_pjt7618_colchallengesblog_BLG_TXT_LDT_0723">Reimbursement for laboratory-developed and <i>in vitro</i> diagnostic tests<span class="Apple-converted-space"> </span></a><br /> Paper: <a href="https://www.thermofisher.com/us/en/home/global/forms/life-science/intellectual-property-diagnostic-tests.html?icid=_gsd_gts_pjt7618_colchallengesblog_BLG_TXT_LDT_0723">Intellectual property associated with laboratory-developed tests (LDTs) and <i>in vitro </i>diagnostic (IVD) tests</a><span class="Apple-converted-space"> </span></p> <p><strong>About the Speaker</strong><br /> <img decoding="async" style="width: auto;height: auto;padding-right: 10px;padding-bottom: 10px" src="https://www.thermofisher.com/blog/clinical-conversations/wp-content/uploads/sites/18/2021/12/Headshot-VijaySingh-310x274-1-150x150.jpg" alt="" width="120" height="120" align="left" /></p> <p>Dr. Vijay Singh is the Director of Molecular Diagnostics at HealthTrackRx in Denton Texas. He has been in this role for over 3 years and leads molecular tests for pathogen targets on the qPCR nanofluidics platform. Prior to this role, he did his PhD in Molecular Biology and Post-Doctoral training in Metabolic Engineering at the University of North Texas.</p> <aside class="mashsb-container mashsb-main "> <div class="mashsb_above_buttons"></div> </aside>  </div></article></main></div></div><footer class="site-footer"><div class="wrap"><div class="creds"><p class="footer-links"><a href="https://corporate.thermofisher.com/en/footer/privacy-statement.html" target="_blank" rel="noopener noreferrer">Privacy Statement</a><a href="https://corporate.thermofisher.com/en/footer/terms-and-conditions.html" target="_blank" rel="noopener noreferrer">Terms & Conditions</a><a href="/blog/locations/">Locations</a><a href="/blog/sitemap/">Sitemap</a></p><p>© 2024 <a href="https://www.thermofisher.com">Thermo Fisher Scientific</a>. 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