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<li><a href="#">Overview</a><ul>
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<li><a title="Submission overview" href="/gtr/docs/submit/">Submission to GTR</a></li>
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<li><a href="#">Genetic Test Submission</a><ul>
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<li><a title="Overview of genetic test submissions" href="/gtr/docs/submit/">Getting started</a></li>
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<li><a title="Instructions for clinical genetic test submissions" href="/gtr/docs/submit/add_test/">Clinical tests</a></li>
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<li><a title="Instructions for spreadsheet submissions for clinical genetic tests" href="/gtr/docs/fulltest/">Clinical tests by spreadsheet</a></li>
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<li><a title="Instructions for API submissions for clinical genetic tests" href="/gtr/docs/gtr_api_http/">Clinical tests by api</a></li>
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<li><a title="Instructions for research genetic test submissions" href="/gtr/docs/submit/add_research/">Research tests</a></li>
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</ul>
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<li><a href="#">Microbe Test Submission</a><ul>
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<li><a title="Overview of microbe test submissions" href="/gtr/docs/microbe_test/">Getting started</a></li>
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<li><a title="Instructions for clinical microbe test submissions" href="/gtr/docs/submit/add_microbe_clinical/">Clinical tests</a></li>
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<li><a title="Instructions for spreadsheet submissions for clinical microbe tests" href="/gtr/docs/microbe_fulltest/">Clinical tests by spreadsheet</a></li>
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<li><a title="Instructions for API submissions for clinical microbe tests" href="/gtr/docs/gtr_api_http/">Clinical tests by api</a></li>
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<li><a title="Instructions for research microbe test submissions" href="/gtr/docs/submit/add_microbe_research/">Research tests</a></li>
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</ul>
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</li>
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<li><a href="#">Search GTR</a><ul>
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<li><a title="How to use and search the GTR website" href="/gtr/docs/help/">Search tips</a></li>
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<li><a href="https://www.youtube.com/playlist?list=PL7dF9e2qSW0a1b37gVee-pYFZ4AEOGvqw">YouTube library</a>
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<span id="shared-content-1"></span></li>
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<div class="container">
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<div id="maincontent" class="content col twelve_col last">
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<div class="col1">
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<div><div id="static-page-tools"><div style="display:inline-block;"><form id="form-helpdocs" action="/gtr/docs/" method="get"><label class="ui-helper-hidden-accessible" for="helpdocs-search-term">Search GTR Help Documents</label><input autocomplete="off" value="" placeholder="Search GTR Help Documents" name="term" id="helpdocs-search-term" style="width:30em;" /><button id="search">Search GTR help documents</button></form></div><ul><li class="print"><a href="#" id="print-this" title="Print this document">Print this document</a></li></ul></div><h1 id="frequently-asked-questions-faq-f">Frequently Asked Questions (FAQ) for the NIH Genetic Testing Registry (GTR)</h1>
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<p><strong>TIP</strong>: Browse by subcategory, or use your browser's Find function to identify a term of interest in a question or its answer.</p>
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<div class="toc">
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<ul>
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<li><a href="#purpose-and-scope">Purpose and Scope</a></li>
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<li><a href="#faqsub">Submitting Test Information</a></li>
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<li><a href="#logging-into-the-gtr-submission-">Logging into the GTR Submission Portal</a></li>
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<li><a href="#faqcontent">GTR Content</a></li>
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<li><a href="#faq-qa">Quality Assurance</a></li>
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<li><a href="#stakeholder-involvement">Stakeholder Involvement</a></li>
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<li><a href="#paperwork-reduction-act">Paperwork Reduction Act</a></li>
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<li><a href="#faqtransition">Transition from GeneTests to GTR</a></li>
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<li><a href="#insurance-providers-and-gtr">Insurance providers and GTR</a></li>
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</ul>
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</div>
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<h2 faq-ps="faq-ps" id="purpose-and-scope">Purpose and Scope</h2>
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<ol>
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<li>
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<p><strong>Q.</strong> Will the Genetic Testing Registry include results from testing?</p>
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<p><strong>A.</strong> No. The Genetic Testing Registry does not include data from individuals’ test results.</p>
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</li>
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<li>
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<p><strong>Q.</strong> What are the benefits of the Genetic Testing Registry?</p>
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<p><strong>A.</strong> The National Institutes of Health expects that the Genetic Testing Registry will benefit a large stakeholder community including health care providers, researchers, test providers, insurance companies, and public health officials. Anticipated benefits include: </p>
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<ul>
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<li>Expanding publicly available information for clinicians, researchers, and others about test availability; indications for testing; and data about the accuracy, validity, and usefulness of a test.</li>
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<li>Identifying gaps in scientific knowledge.</li>
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<li>Enabling test providers to identify and connect with other providers to create collaborations, such as participating in quality assurance exchanges.</li>
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<li>Understanding trends in genetic testing over time, such as the uptake of next-generation sequencing by clinical testing labs.</li>
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<li>Streamlining the billing and reimbursement processes.</li>
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</ul>
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</li>
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<li>
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<p><strong>Q.</strong> Why did the National Institutes of Health develop the Genetic Testing Registry?</p>
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<p><strong>A.</strong> The National Institutes of Health (NIH) is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research. Within NIH, the National Library of Medicine (NLM) and the National Center for Biotechnology Information (NCBI) support efforts to advance medicine and public health by sharing information and developing automated systems for storing and analyzing knowledge about molecular biology, biochemistry, and genetics. Currently, NLM and NCBI maintain a large number of public databases and resources that are heavily used by researchers, clinicians, consumers, and patients. The Genetic Testing Registry (GTR) is integrated with relevant NIH resources to assist each of these groups. Thus, NIH is a natural home for the GTR because of its role in advancing public health through science and its strong expertise in developing databases.</p>
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</li>
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<li>
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<p><strong>Q.</strong> What is the intended audience for the Genetic Testing Registry?</p>
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<p><strong>A.</strong> The Genetic Testing Registry (GTR) is intended primarily for health care providers and researchers. Future phases may incorporate features designed for a user base that includes patients and the general public.</p>
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</li>
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<li>
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<p><strong>Q.</strong> What is the goal of the Genetic Testing Registry?</p>
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<p><strong>A.</strong> The overarching goal of the Genetic Testing Registry (GTR) is to advance public health and research into the genetic basis of health, disease and infectious diseases. As such, the GTR has the following key functions:</p>
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<ul>
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<li>Encourage providers of genetic tests to enhance transparency by publicly sharing information about the scientific basis and utility of their tests;</li>
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<li>Provide an information resource for the public, particularly health care providers, to locate laboratories that offer particular tests; and</li>
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<li>Facilitate genetic and genomic data-sharing for research and new scientific discoveries.</li>
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</ul>
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</li>
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<li>
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<p><strong>Q.</strong> What is the purpose of the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> The Genetic Testing Registry (GTR) is an online tool that enables health care providers, researchers, and others to navigate the rapidly changing landscape of genetic tests. It also has molecular and serologic tests for microbes. GTR has detailed information about genetic tests for more than 22,000 phenotypes including inherited conditions — a number that has grown steadily and continues to rise. However, until the GTR, limited information about genetic tests was scattered across multiple databases. The GTR is a centralized, publicly available database that aims to provide comprehensive information about genetic and infectious disease tests.</p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 id="faqsub">Submitting Test Information</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> What is the easiest way to get started on my submission?</p>
|
||
<p><strong>A.</strong> The <a href="/gtr/docs/submit/">Submission Overview</a> page has guidance about how to register your lab and tests. If you need assistance, please contact <a href="mailto:tkt-tryhd@ncbi.nlm.nih.gov?subject=Question%20about%20submitting%20to%20GTR">GTR staff</a>.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q:</strong> What type of information can be submitted to the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> The Genetic Testing Registry (GTR) is designed to provide a wide range of information about tests such as the purpose of the test and its limitations; the name, location, and credentials of laboratories providing the test; whether it is a clinical or research test; the testing method and what the test measures; analytical validity data, and evidence of clinical validity and clinical utility. The GTR will not include individual test results or other confidential or proprietary information.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q:</strong> Is participation in the Genetic Testing Registry mandatory?</p>
|
||
<p><strong>A.</strong> No. Participation in the Genetic Testing Registry is not mandatory. Providers of tests are encouraged to submit test information voluntarily.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q:</strong> What is the cost to participate in the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> There is no cost to submit information to the Genetic Testing Registry (GTR). Test providers can submit information about a single test or multiple tests, at no charge. It is also free to access information in the GTR.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q:</strong> How should test submitters refer to their participation in the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> Test submitters may refer to the fact that information about their tests is available in the Genetic Testing Registry (GTR) and provide the relevant URL(s). Before providing test information to the GTR, submitters must agree to abide by a code of conduct, which stipulates that submitters make no explicit or implicit claims that their tests listed in the GTR, or other information submitted to the GTR, have been approved or endorsed by the National Institutes of Health (NIH), the Department of Health and Human Services, or the U.S. Government. If this stipulation is not honored, NIH reserves the right to take action, including, in its sole discretion, removing the submitter’s tests from the GTR.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q:</strong> How will submissions to the Genetic Testing Registry be referenced, and will they be linked to other National Institutes of Health resources?</p>
|
||
<p><strong>A.</strong> Each test in the Genetic Testing Registry (GTR) is assigned a unique accession number, allowing for uniform reference to tests across various entities, including scientific publications and electronic health records. In addition, the GTR is integrated with other National Institutes of Health databases and resources.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q:</strong> Who can contribute test information to the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> Test providers who perform all or some portions of a test can submit information to the Genetic Testing Registry. Test providers include U.S. and international clinical and research laboratories.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How can more than one person from a laboratory register tests?</p>
|
||
<p><strong>A.</strong> Submission of lab and test data from multiple individuals for a single laboratory is enabled in a function called '<a href="/gtr/docs/manage_permissions/">Groups</a>'. Please <a href="mailto:tkt-tryhd@ncbi.nlm.nih.gov?subject=Question%20about%20account%20access%20to%20GTR">contact us</a> if you would like to use this feature. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> Can I register our research tests?</p>
|
||
<p><strong>A.</strong> Submitters may register research tests in GTR. The definition of a research test in GTR is provided <a href="/gtr/docs/about/#DefResTest">here</a>. Test information focuses on the research study and how to enroll. Instructions for getting started are located <a href="/gtr/docs/submit/add_research/">here</a>. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> Can I register our somatic tests?</p>
|
||
<p><strong>A.</strong> Submitters may register somatic tests in GTR. In clinical and research tests, test targets can be identified as germline, somatic or both as described <a href="/gtr/docs/submit/test_method/#targets">here</a>. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q:</strong> How can I register custom panels in GTR?</p>
|
||
<p><strong>A.</strong> A clinical test in the GTR is defined as the equivalent of a laboratory order code. Each custom panel can be registered as a separate test to get a unique GTR ID. You can also register your custom panel in one of two ways:
|
||
1. a large panel with all possible genes (indicating in the test comment field that genes on this panel can be selected/unselected at the ordering provider’s discretion.
|
||
2. by phenotype grouping (some examples can be cardiology, neurology and RASopathies). You can specify that a test is a custom panel in the test name, how to order, and test comment fields.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How long does it take to receive a GTR ID for a test?</p>
|
||
<p><strong>A.</strong> Laboratory information must be entered first. New laboratories go through a review process that takes two to three business days and requires answers to a questionnaire sent via email. Once the lab is approved, test information can be submitted. When a test is submitted and processed successfully, the test information with the GTR ID is available on the public site within 24 to 48 hours.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> Do I need to register send-out tests in GTR?</p>
|
||
<p><strong>A.</strong> You can register tests for which your laboratory performs at least part of the test: specimen preparation, wet lab work, interpretation, or report generation. Send-out tests where no part of the test is done by your lab should not be registered – the reference lab can register the test. GTR aims to bring transparency to the genetic testing landscape and to make sure a test is only registered once, the lab performing the test is expected to be the one registering it.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> I’ve completed registration for my lab but why am I unable to see it on the public site?</p>
|
||
<p><strong>A.</strong> The information should be available on the public site within 24-48 hours after registration. <a href="mailto:tkt-tryhd@ncbi.nlm.nih.gov?subject=Question%20about%20lab%20record%20in%20GTR">Contact us</a> if you do not see your laboratory record. </p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 id="logging-into-the-gtr-submission-">Logging into the GTR Submission Portal</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> How do I access my account in the GTR Submission Portal?</p>
|
||
<p><strong>A.</strong> For step by step instructions, see <a href="https://www.ncbi.nlm.nih.gov/gtr/docs/login/#login">Login to the Submission Portal</a>.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> Help! I lost my login information for myNCBI account (to access GTR).</p>
|
||
<p><strong>A.</strong> Click "login/sign in" in the upper right-hand corner; Below the blue "sign in" button, click the link “Forgot NCBI username or password?”. Follow the instructions to get your username or reset your password. For more help, please contact NCBI staff at <a href="mailto:tkt-tryhd@ncbi.nlm.nih.gov?subject=Need%20help%20with%20GTR%20username%20or%20password">tryhd@ncbi.nlm.nih.gov</a>. </p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 id="faqcontent">GTR Content</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> What information is in scope for GTR?</p>
|
||
<p><strong>A.</strong> The GTR contains information about clinical and research tests for Mendelian disorders and drug responses as well as somatic / cancer tests. Labs that offer whole exome sequencing and whole genome sequencing can be found by searching Laboratory services or via links from the home page and elsewhere. Molecular and serologic clinical and research tests for microorganisms that play a role in human health and infectious disease are also within scope for GTR; examples, nucleic acid amplification and serologic tests for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus which causes COVID-19. Read more <a href="/gtr/docs/about/#currentcontent">here</a>. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> What determines the order of search results?</p>
|
||
<p><strong>A.</strong> Relevance of the search term and completeness of the submitted data determine the order within lists of results. Ranking of search results is discussed <a href="/gtr/docs/about/#ranking">here</a>. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How can I learn how to use GTR?</p>
|
||
<p><strong>A.</strong> Get started by viewing <img src="https://static.pubmed.gov/portal/portal3rc.fcgi/4057559/img/2317562" alt="GTR overview and search tips" /> <a href="https://www.youtube.com/playlist?list=PL7dF9e2qSW0a1b37gVee-pYFZ4AEOGvqw" class="adv_youtube">GTR Tutorials</a> and reading the <a href="/gtr/docs/help/">How to use GTR</a> help page (both accessible from the Home page). Learn how to quickly find tests, compare labs, filter your results, find <em>GeneReviews</em>, and set preferences. Search the help pages for the information you need. Review the GTR fact sheet and view a webinar. Contact us for help. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> Starting from <em>GeneReviews</em>, how do I find tests in GTR?</p>
|
||
<p><strong>A.</strong> New links to testing information in GTR are located along the right hand side of <em>GeneReview</em> summaries, labeled ‘Tests in GTR by Gene’ and ‘Tests in GTR by Condition’. Read more <a href="/gtr/docs/help/#GTRtests_GR">here</a>. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How can I find a test that is no longer in GTR?</p>
|
||
<p><strong>A.</strong> Laboratories can remove tests from GTR at any time. When a laboratory removes a test from their test menu, that test will not display in GTR anymore. You can contact the laboratory directly to ask about a a specific test. Contact details can be found on the lab page. </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How can I find previous versions of a test? </p>
|
||
<p><strong>A.</strong> GTR test accessions have a total of 9 digits; ‘GTR’ prefix followed by 9 digits and include the unique GTR ID (GTR000######). If the GTR ID is less than 6 digits, replace digit with 0. </p>
|
||
<p>You can search for a specific version of a test using this format: GTR000######.# </p>
|
||
<p>For example, to get version 4 of a test, search for GTR000######.4 </p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> What has been the level of submitter participation in GTR thus far?</p>
|
||
<p><strong>A.</strong> For a current count of all labs and tests registered in GTR, click <a href="/gtr/all/tests/?term=all%5Bsb%5D%C2%A0">here</a>.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How is the COVID-19 pandemic affecting lab accreditations and renewals?</p>
|
||
<p><strong>A.</strong> Due to the COVID-19 pandemic, some entities are experiencing delays with their protocols (e.g., inspections), and lab certifications and accreditations remain valid past the due date until the process is completed. For CAP, please read <a href="https://www.cap.org/laboratory-improvement/news-and-updates/cap-inspections-covid-19-update">this update</a>. For CLIA, please refer to the <a href="https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf">FAQ</a> for information. For other entities and individual state agencies, please refer to them directly for updates regarding accreditations.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> What is "classic" view?</p>
|
||
<p><strong>A.</strong> In April 2024, GTR released a new viewer on the public website for clinical and research genetic tests. The previous "classic" view will be available via a link at the top of the page, "Classic view of this page". Microbe tests will display in classic view only.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How are clinical category labels applied to tests?</p>
|
||
<p><strong>A.</strong> See the documentation for <a href="/gtr/docs/test_categories">Clinical test categories</a>.</p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 id="faq-qa">Quality Assurance</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> What action will the National Institutes of Health (NIH) take if test submitters do not review submitted information at least once a year?</p>
|
||
<p><strong>A.</strong> Test submitters agree to abide by a code of conduct, which stipulates that they will review and, if necessary, update the submitted information at least once a year. The NIH National Center for Biotechnology Information sends submitters an annual reminder of this obligation. If this stipulation is not honored by a test submitter, information that is more than one year old will be labeled as out of date. NIH reserves the right to take action, including removing out-of-date submissions from the GTR if the information is two years beyond the last annual review.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> What action will the National Institutes of Health (NIH) take if it discovers that submitted test information is inaccurate or misleading?</p>
|
||
<p><strong>A.</strong> Test submitters agree to abide by a code of conduct, which stipulates that they will uphold the integrity of the GTR through the submission of information that is accurate and not misleading. If this stipulation is not honored by a test submitter, NIH reserves the right to take action, including, in its sole discretion, requesting that the test submitter amend inaccurate or misleading information or, if a submitter fails to respond to this request, removing the relevant submission from the GTR.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> What action will the National Institutes of Health (NIH) take if marketing materials state that NIH endorses a test?</p>
|
||
<p><strong>A.</strong> Test submitters agree to abide by a code of conduct, which stipulates that submitters make no explicit or implicit claims that their tests listed in the GTR, or other information submitted to the GTR, have been approved or endorsed by NIH, the Department of Health and Human Services, or the U.S. Government. If this stipulation is not honored by a test submitter, NIH reserves the right to take action, including, in its sole discretion, requesting that the test submitter amend its marketing materials to delete any such claims or, if a submitter fails to respond to this request, removing the relevant submission from the GTR. Marketing materials may refer to the fact that test information is provided in the GTR.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How will NIH assure the quality of the test information provided to the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> NIH does not verify the content of information submitted to the Genetic Testing Registry (GTR) by test providers. Submitters will be solely responsible for the content and quality of the data they provide to the GTR. However, NIH recognizes that it is critically important to ensure that GTR users understand that neither NIH, nor the government in general, endorses tests or has verified the accuracy of test information in the GTR. NIH implemented the following measures to ensure that these limitations are as clear as possible and also to hold submitters accountable for their responsibilities:</p>
|
||
<ul>
|
||
<li>The National Center for Biotechnology Information (NCBI) incorporates basic administrative checks for mistakes made by the submitter during the submission process. </li>
|
||
<li>Submitters must agree to abide by the terms of a code of conduct and action will be taken, based on standard operating procedures, if submitters violate these terms. </li>
|
||
<li>A prominent disclaimer on the GTR homepage clearly states that NIH does not independently verify information submitted to the GTR. </li>
|
||
<li>NCBI assigns a unique accession number to each test, allowing uniform reference to tests in scientific publications; which facilitates third-party evaluations of GTR content. </li>
|
||
<li>In addition, NCBI can link published reviews to tests referenced in publications. </li>
|
||
<li>NCBI links to external resources such as professional practice guidelines and studies that support or refute claims made by submitters. </li>
|
||
<li>GTR users can contact NCBI staff to report information that appears to be incorrect. </li>
|
||
</ul>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 faq_si="faq_si" id="stakeholder-involvement">Stakeholder Involvement</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> How can I learn more about the Genetic Testing Registry and provide feedback?</p>
|
||
<p><strong>A.</strong> The National Center for Biotechnology Information (NCBI) provides tutorials and information on <a href="https://www.ncbi.nlm.nih.gov/gtr/docs/help/">how to use</a> the Genetic Testing Registry (GTR). <a href="mailto:tkt-tryhd@ncbi.nlm.nih.gov?subject=Feedback%20to%20GTR">Contact us</a> to provide feedback or ask questions about GTR.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How did stakeholder input help the National Institutes of Health shape the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> The National Institutes of Health (NIH) is appreciative of the thoughtful stakeholder feedback, which helped to define the scope of the Genetic Testing Registry (GTR), improve site navigation, enhance usability, and identify data elements important to potential GTR users as well as elements that would be difficult or burdensome for test developers to provide. Examples of changes based on stakeholder input are:</p>
|
||
<ul>
|
||
<li>NIH decided to use a phased approach in building the GTR, and stakeholder comments helped prioritize the types of tests that are included in the initial phase. Phase I includes single-gene tests for heritable mutations, including pharmacogenomic tests, and multiplex panels and arrays. Phase II includes tests for somatic mutations such as genetic variants in tumors and tests using whole-exome or whole-genome sequencing. Subsequent phases will add tests for infectious agents and direct-to-consumer genetic tests.</li>
|
||
<li>NIH focused on health care providers as the intended audience for the initial phase of the GTR; future phases may expand the audience to include patients and the general public.</li>
|
||
<li>NIH excluded certain data elements, at least from the initial phase of GTR, such as test price, turn-around time, and patent and licensing information.</li>
|
||
</ul>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> Did the National Institutes of Health involve stakeholders during the development of the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> Yes, consulting with stakeholders—such as laboratory test developers, manufacturers, and health care providers—was a key step in the development of the Genetic Testing Registry (GTR), and continued stakeholder interaction will help optimize the GTR’s utility. Stakeholder comments were solicited through the following means:</p>
|
||
<ul>
|
||
<li>Request for Information (RFI), Federal Register notice, June 11, 2010, 68 public comments. </li>
|
||
<li>Public Stakeholder Meeting, November 2, 2010, 17 public comments and meeting discussion. </li>
|
||
<li>Request for Comments, Federal Register notice, July 27, 2011, 12 public comments. </li>
|
||
<li>Request for Comments, Federal Register notice, November 23, 2011, public comments. </li>
|
||
<li>Consultation with two GTR clinical advisory groups: four meetings with clinical experts from within NIH and six meetings of a medical genetics working group of the National Center for Biotechnology Information Board of Scientific Counselors in 2010-2011. </li>
|
||
<li>Meetings with other government agencies that have an interest in genetic testing (e.g., the Food and Drug Administration and the Centers for Medicare & Medicaid Services), three meetings in 2010-2011. </li>
|
||
<li>In-person meetings or teleconferences with stakeholder groups, 19 meetings in 2010-2011. </li>
|
||
<li>Presentations and discussion at meetings of professional organizations, 7 meetings in 2010-2011. </li>
|
||
<li>Comments submitted through “Contact GTR,” 95 comments received in 2010-2011. </li>
|
||
</ul>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> Does the National Institutes of Health collaborate with other agencies in the Department of Health and Human Services that are interested in genetic test information?</p>
|
||
<p><strong>A.</strong> Yes. NIH consults with the Food and Drug Administration and the Centers for Medicare & Medicaid Services (which enforces regulations based on the Clinical Laboratory Improvement Amendments) to streamline the process of data submission for test providers who may be required to provide similar information to these HHS agencies.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> How was the Genetic Testing Registry designed?</p>
|
||
<p><strong>A.</strong> The Genetic Testing Registry was designed by the National Institutes of Health (NIH) National Center for Biotechnology Information with extensive input from the stakeholder community, including clinicians and test providers, under the oversight of an NIH steering committee.</p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 faq-pra="faq-pra" id="paperwork-reduction-act">Paperwork Reduction Act</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> Does the Paperwork Reduction Act apply to the Genetic Testing Registry?</p>
|
||
<p><strong>A.</strong> Yes. The Paperwork Reduction Act applies to the Genetic Testing Registry (GTR) because the National Institutes of Health, a federal agency, is collecting standardized information from 10 or more respondents (i.e., laboratories that provide genetic tests) within a 12-month period. The Paperwork Reduction Act requires two periods for the public to provide comments about the proposed information collection. You can read the public comments that were requested on July 27, 2011, and November 23, 2011.</p>
|
||
</li>
|
||
<li>
|
||
<p><strong>Q.</strong> What is the Paperwork Reduction Act?</p>
|
||
<p><strong>A.</strong> The Paperwork Reduction Act (PRA) was passed by Congress in 1980 and requires that federal agencies receive Office of Management and Budget (OMB) clearance before requesting most types of information from the public (“information collections”). Specifically, PRA clearance is required when standardized information is collected from 10 or more respondents within a 12-month period. The OMB regulation that implements the PRA is at 5 CFR 1320. Additional PRA information is available from the Department of Health and Human Services.</p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 id="faqtransition">Transition from GeneTests to GTR</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> What has happened to GeneTests and how does that relate to GTR?</p>
|
||
<p><strong>A.</strong> As of June 4th, 2013, the NIH no longer supports the GeneTests Laboratory Directory, but continues to support <em>GeneReviews</em>. GeneTests webpages that have resided at NCBI either redirect to GTR or to NCBI's Bookshelf, which continues to house <em>GeneReviews</em>. <em>GeneReviews</em> are thoroughly integrated into GTR, as described <a href="/gtr/docs/help/#find_genereviews">here</a>.</p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<h2 id="insurance-providers-and-gtr">Insurance providers and GTR</h2>
|
||
|
||
|
||
<ol>
|
||
<li>
|
||
<p><strong>Q.</strong> Who can I contact if I have questions about UnitedHealthcare’s Molecular Pathology Reimbursement Policy?</p>
|
||
<p><strong>A.</strong> If you have questions, please call UnitedHealthcare Provider Services at 877-842-3210. You can also call BeaconLBS at 800-377-880.
|
||
For more information, please go to: https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/COMM-Molecular-Pathology-Policy-FAQ.pdf</p>
|
||
</li>
|
||
</ol>
|
||
|
||
|
||
<p><a href="mailto:tkt-tryhd@ncbi.nlm.nih.gov?subject=GTR%20help%20request">Contact us</a> if you have a question or a comment.</p>
|
||
|
||
|
||
<p><span id="shared-content-1"></span></p></div>
|
||
|
||
</div>
|
||
<!--/.col1-->
|
||
<div class="col2">
|
||
|
||
</div>
|
||
<!--/.col2-->
|
||
<div class="col3">
|
||
|
||
</div>
|
||
<!--/.col3-->
|
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