{"id":2419,"date":"2022-02-25T08:57:31","date_gmt":"2022-02-25T13:57:31","guid":{"rendered":"https:\/\/geneticspolicy.nccrcg.org\/?post_type=policy-area&#038;p=2419"},"modified":"2024-09-19T11:58:50","modified_gmt":"2024-09-19T15:58:50","slug":"laboratory-regulation-oversight","status":"publish","type":"policy-area","link":"https:\/\/geneticspolicy.nccrcg.org\/policy-area\/laboratory-regulation-oversight\/","title":{"rendered":"Laboratory (Regulation\/Oversight)"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; theme_builder_area=&#8221;post_content&#8221; _builder_version=&#8221;4.17.3&#8243; _module_preset=&#8221;default&#8221;][et_pb_fullwidth_header _builder_version=&#8221;4.17.3&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#cc1b00&#8243; custom_padding=&#8221;4px||1px|||&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;]<\/p>\n<p>From 2004 to 2024, the Health Resources and Services Administration (HRSA) funded the National Coordinating Center for the Regional Genetics Networks (NCC). NCC developed and maintained the Genetics Policy Hub.<\/p>\n<p>&nbsp;<\/p>\n<p>With the conclusion of NCC funding, the Genetics Policy Hub (GPH) will no longer be updated or maintained. Information on GPH should be used for historical reference only.<\/p>\n<p>[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; top_divider_color=&#8221;#ffffff&#8221; top_divider_height=&#8221;15px&#8221; bottom_divider_style=&#8221;asymmetric&#8221; bottom_divider_color=&#8221;#ffffff&#8221; bottom_divider_height=&#8221;25px&#8221; bottom_divider_repeat=&#8221;1x&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_post_title meta=&#8221;off&#8221; featured_image=&#8221;off&#8221; text_color=&#8221;light&#8221; admin_label=&#8221;Fullwidth Post Title&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; title_text_align=&#8221;center&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;145deg&#8221; background_color_gradient_stops=&#8221;#361420 30%|#005973 100%&#8221; background_color_gradient_start=&#8221;#361420&#8243; background_color_gradient_start_position=&#8221;30%&#8221; background_color_gradient_end=&#8221;#005973&#8243; custom_padding=&#8221;34px||34px||false|false&#8221; custom_padding_tablet=&#8221;34px||34px||false|false&#8221; custom_padding_phone=&#8221;20px||20px||false|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; title_font_size_tablet=&#8221;40px&#8221; title_font_size_phone=&#8221;30px&#8221; title_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_fullwidth_post_title][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;2_3,1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;2_3&#8243; admin_label=&#8221;Main Body&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text admin_label=&#8221;Last Updated On&#8221; module_class=&#8221;last_update_on&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|700||on|||||&#8221; text_text_color=&#8221;rgba(0,0,0,0.5)&#8221; text_font_size=&#8221;12.5px&#8221; custom_margin=&#8221;30px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Updated On <style>\n    \/* Short Code Modules *\/\n    .insert_last_update_date.last_update_date{\n        background-color: #f9f9f9;\n        color: #444444;\n        font-size: 100%;\n        padding: 0.2rem 0.5rem;\n        border-radius: 1rem;\n    }\n<\/style>\n<span class=\"insert_last_update_date last_update_date\">Sep 19, 2024<\/span>\n\n<\/p>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;PDF &#038; Print&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; positioning=&#8221;absolute&#8221; position_origin_a=&#8221;top_right&#8221; vertical_offset=&#8221;20px&#8221; width=&#8221;100%&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"pdfprnt-buttons\"><a href=\"javascript: imageToPdf()\" class=\"pdfprnt-button pdfprnt-button-pdf\" target=\"_self\"><img decoding=\"async\" src=\"https:\/\/geneticspolicy.nccrcg.org\/wp-content\/uploads\/pdf-print-buttons\/pdf_button.png?134760547\" alt=\"image_pdf\" title=\"View PDF\" \/><span class=\"pdfprnt-button-title pdfprnt-button-pdf-title\">View as PDF<\/span><\/a><\/div>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;rgba(114,114,114,0.95)&#8221; text_font_size=&#8221;14px&#8221; background_enable_color=&#8221;off&#8221; box_shadow_horizontal_last_edited=&#8221;off|desktop&#8221; global_colors_info=&#8221;{}&#8221; box_shadow_horizontal__hover_enabled=&#8221;off|desktop&#8221;]<\/p>\n<p>This information is meant to be used for educational purposes to inform providers, patients, and genetic service delivery stakeholders about genetics policy topics. Sharing of information, resources, or policy statements is no way an endorsement of stated positions by NCC.<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Introduction<\/h2>\n<p>Genetic tests are an important tool used to diagnose illness. Having a accurate tests is crucial for patient care. Yet, many genetic tests are not regulated; they are released to the public without any independent analysis to verify their ability to correctly return results. For more information on how genetic tests are regulated, please visit the National Human Genome Research Institute (NHGRI) <a href=\"https:\/\/www.genome.gov\/about-genomics\/policy-issues\/Regulation-of-Genetic-Tests\" target=\"_blank\" rel=\"noopener\">website<\/a>.<\/p>\n<p>Some have proposed that genetic tests be approved and regulated by the federal government. However, who should regulate genetic tests and how is still a matter of debate. Regulating genetic laboratory tests is difficult because genetic tests results rely on subjective interpretation. In traditional laboratory tests, the lab measures the amount of a substance. For example, if you have an iron test done, the laboratory measures the amount of iron in your blood. They know the range that is normal. Anything above that range is interpreted as high; and anything below that range is interpreted as low. Genetic tests are not that straightforward, and need an expert to interpret them. For example, when looking at a particular gene, we might know that most people\u2019s genes are configured in a certain order. If a patient\u2019s gene is different, the experts then need to determine if the patient\u2019s variation of the gene causes disease or not. This can be done by looking at the other people with the same genetic variant to see if they have disease, by looking at research studies that look at the proteins made by these genes, and by looking at computer models that predict how the genes will work. After looking at all of this information, the experts then interpret the genetic variant. Sometimes, they are able to interpret the genetic variant with confidence. Other times, they are unable to determine if it causes disease or not.<\/p>\n<p>Because genetic testing and interpretation is complex and relies on interpretation, regulation and oversight is not straightforward. For example, the FDA regulates laboratory devices, like gene sequencers. However, the FDA would not be responsible for oversight of the interpretation of the test result, as that is not a device.<\/p>\n<h2>Legislation and Regulation<\/h2>\n<p>Genetic tests are regulated at a federal level by the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Federal Trade Commission (FTC). For more information on how tests can be evaluated, review the National Human Genome Research Institute (NHGRI) website <a href=\"https:\/\/www.genome.gov\/about-genomics\/policy-issues\/Regulation-of-Genetic-Tests\" target=\"_blank\" rel=\"noopener\">page<\/a> about genetic testing.<\/p>\n<p>Are you interested in learning what your state\u2019s government or the federal government are currently proposing for either legislation or regulation? Check out <a href=\"https:\/\/geneticspolicy.nccrcg.org\/legislative-policies\/\" target=\"_blank\" rel=\"noopener\">Legislative\/Tracking system<\/a> for up-to-date information and subscribe to our <a href=\"https:\/\/twitter.com\/geneticspolicy\" target=\"_blank\" rel=\"noopener\">Twitter<\/a> channel to get the latest updates in your pocket.<\/p>\n<h2>Policy Positions<\/h2>\n<div>\n<p><span>Organizations working within the genetics community (national genetic organizations, advocacy organizations, etc.) have published positions on laboratory regulation\/oversight. Explore these position statements below.<\/span><\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n    <span><\/span>\n    <style>\n        \/* Fix for empty P tag *\/\n        .wp-block-group__inner-container > p{\n            display: none;\n        }\n        .position-widget {\n            margin: -2rem 0 2rem;\n        }\n        .position-widget .header{\n            display: block;\n            background-color: #efefef;\n            color: #444444;\n            font-size: 0.8rem;\n            text-align: center;\n            border-radius: 5px 5px 0 0;\n        }\n        .position-widget .body{\n            padding: 0 0 1rem 0;\n            background-color: #efefef;\n            border-radius: 0 0 5px 5px;\n            box-shadow: 0px 0px 5px inset rgba(0,0,0, 0.2);\n        }\n        .position-widget .body > .scroller{\n            padding: 1rem 1rem 0 1rem;\n            overflow-y: auto;\n            max-height: 500px;\n        }\n        .position-widget .body .scroller > .wrapper{\n            display: flex;\n            align-items: center;\n            justify-content: left;\n            flex-flow: row wrap;\n            align-content: flex-start;\n        }\n        .position-widget .body .scroller > .wrapper > .item{\n            flex: 33.3%;\n            max-width: 33.3%;\n            padding: 0 1rem 1rem 0;\n            box-sizing: border-box;\n        }\n        .position-widget .body .scroller > .wrapper > .item .item_wrapper{\n            border: 1px solid #fff;\n            background-color: #fff;\n            padding: 1rem;\n            border-radius: 5px;\n            box-shadow: 0 0 5px rgba(0,0,0,0.2);\n        }\n        .position-widget .body .scroller > .wrapper > .item:hover .item_wrapper{\n            border: 1px solid #999;\n        }\n        .position-widget .body .scroller > .wrapper div.item h6{\n         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    padding: 5px 5px;\n            border-radius: 20px;\n            font-size: 0.8rem;\n            color: #fff;\n        }\n        .position-widget .body .scroller > .wrapper div.item div.field.subject .value{\n            overflow: hidden;\n            white-space: nowrap;\n        }\n        .position-widget .body .scroller > .wrapper div.item div.field.subject .value span{\n            display: inline-block;\n            color: #000;\n        }\n        .position-widget .body .scroller > .wrapper .item  div.field{\n            margin-bottom: 1rem;\n        }\n        .position-widget .body .scroller > .wrapper .item  div.field:last-child{\n            margin-bottom: 0;\n        }\n        .position-widget .body .scroller > .wrapper  .item  div.field .label{\n            font-size: 0.7rem;\n            color: #444444;\n            text-transform: uppercase;\n            line-height: 1.2;\n        }\n        .position-widget .footer{\n            text-align: right;\n        } \n        .position-widget .footer a.export span{\n            font-size: 0.8rem;\n            font-weight: bold;\n        }\n    <\/style>\n    <div class=\"position-widget\">\n        <div class=\"header\">Position Statements by Organizations<\/div>\n        <div class=\"body\">\n            <div class=\"scroller\">\n                <div class=\"wrapper\">\n                                        <div class=\"item\"> \n                            <div class=\"item_wrapper\">\n                                <h6 title=\"Technical Standards For Clinical Genetics Laboratories\">Technical Standards For Clinical Genetics Laboratories<\/h6>\n\n                                <div class=\"field link\">\n                                    <div class=\"label\">Link<\/div>\n                                    <div class=\"value\"><a href=\"https:\/\/www.acmg.net\/PDFLibrary\/ACMG%20Technical%20Lab%20Standards%20Section%20C.pdf\" target=\"_blank\"  title=\"https:\/\/www.acmg.net\/PDFLibrary\/ACMG%20Technical%20Lab%20Standards%20Section%20C.pdf\" aria-label=\"Hyperlink for this policy position\">https:\/\/www.acmg.net\/PDFLibrary\/ACMG%20Technical%20Lab%20Standards%20Section%20C.pdf<\/a><\/div>\n                                <\/div>\n                                <div class=\"field organization\">\n                                    <div class=\"label\">Organization<\/div>\n                                    <div class=\"value\" style=\"background-color: #c9522a\" title=\"American College of Medical Genetics and Genomics (ACMG)\">American College of Medical Genetics and Genomics (ACMG)<\/div>\n                                <\/div>\n                                <div class=\"field subject\">\n                                    <div class=\"label\">Subject<\/div>\n                                    <div class=\"value\" title=\"Laboratory (regulation\/oversight)\">\n                                                                                <span class=\"subject_entry\" style=\"background-color: #e49a95\">Laboratory (regulation\/oversight)<\/span>\n                                                                            <\/div>\n                                <\/div>\n                                <div class=\"field date\">\n                                    <div class=\"label\">Date<\/div>\n                                    <div class=\"value\">January 1, 2021<\/div>\n                                <\/div>\n                            <\/div>\n                        <\/div>\n                                        <div class=\"item\"> \n                            <div class=\"item_wrapper\">\n                                <h6 title=\"Technical and clinical assessment of fluorescence in situ hybridization: An ACMG\/ASHG position statement. I. Technical considerations\">Technical and clinical assessment of fluorescence in situ hybridization: An ACMG\/ASHG position statement. I. Technical considerations<\/h6>\n\n                                <div class=\"field link\">\n                                    <div class=\"label\">Link<\/div>\n                                    <div class=\"value\"><a href=\"https:\/\/www.acmg.net\/PDFLibrary\/Fluorescence-In-Situ-Hybridization-Clinical-Assessment.pdf\" target=\"_blank\"  title=\"https:\/\/www.acmg.net\/PDFLibrary\/Fluorescence-In-Situ-Hybridization-Clinical-Assessment.pdf\" aria-label=\"Hyperlink for this policy position\">https:\/\/www.acmg.net\/PDFLibrary\/Fluorescence-In-Situ-Hybridization-Clinical-Assessment.pdf<\/a><\/div>\n                                <\/div>\n                                <div class=\"field organization\">\n                                    <div class=\"label\">Organization<\/div>\n                                    <div class=\"value\" style=\"background-color: #c9522a\" title=\"American College of Medical Genetics and Genomics (ACMG)\">American College of Medical Genetics and Genomics (ACMG)<\/div>\n                                <\/div>\n                                <div class=\"field subject\">\n                                    <div class=\"label\">Subject<\/div>\n                                    <div class=\"value\" title=\"Genetic Testing,Laboratory (Regulation\/oversight)\">\n                                                                                <span class=\"subject_entry\" style=\"background-color: #c192cd\">Genetic Testing<\/span>\n                                                                                <span class=\"subject_entry\" style=\"background-color: #e49a95\">Laboratory (Regulation\/oversight)<\/span>\n                                                                            <\/div>\n                                <\/div>\n                                <div class=\"field date\">\n                                    <div class=\"label\">Date<\/div>\n                                    <div class=\"value\">January 1, 2000<\/div>\n                                <\/div>\n                            <\/div>\n                        <\/div>\n                                        <div class=\"item\"> \n                            <div class=\"item_wrapper\">\n                                <h6 title=\"Comments Submitted in Response to FDA\u2019s Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests\">Comments Submitted in Response to FDA\u2019s Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests<\/h6>\n\n                                <div class=\"field link\">\n                                    <div class=\"label\">Link<\/div>\n                                    <div class=\"value\"><a href=\"https:\/\/www.ashg.org\/wp-content\/uploads\/2015\/02\/PS-201502.pdf\" target=\"_blank\"  title=\"https:\/\/www.ashg.org\/wp-content\/uploads\/2015\/02\/PS-201502.pdf\" aria-label=\"Hyperlink for this policy position\">https:\/\/www.ashg.org\/wp-content\/uploads\/2015\/02\/PS-201502.pdf<\/a><\/div>\n                                <\/div>\n                                <div class=\"field organization\">\n                                    <div class=\"label\">Organization<\/div>\n                                    <div class=\"value\" style=\"background-color: #41a819\" title=\"American Society of Human Genetics (ASHG)\">American Society of Human Genetics (ASHG)<\/div>\n                                <\/div>\n                                <div class=\"field subject\">\n                                    <div class=\"label\">Subject<\/div>\n                                    <div class=\"value\" title=\"Genetic Testing,Laboratory Developed Test (LDT),Laboratory (Regulation\/oversight)\">\n                                                                                <span class=\"subject_entry\" style=\"background-color: #c192cd\">Genetic Testing<\/span>\n                                                                                <span class=\"subject_entry\" style=\"background-color: #8ac3c4\">Laboratory Developed Test (LDT)<\/span>\n                                                                                <span class=\"subject_entry\" style=\"background-color: #e49a95\">Laboratory (Regulation\/oversight)<\/span>\n                                                                            <\/div>\n                                <\/div>\n                                <div class=\"field date\">\n                                    <div class=\"label\">Date<\/div>\n                                    <div class=\"value\">February 2, 2015<\/div>\n                                <\/div>\n                            <\/div>\n                        <\/div>\n                                        <div class=\"item\"> \n                            <div class=\"item_wrapper\">\n                                <h6 title=\"Regulation of Genetic Testing\">Regulation of Genetic Testing<\/h6>\n\n                                <div class=\"field link\">\n                                    <div class=\"label\">Link<\/div>\n                                    <div class=\"value\"><a href=\"https:\/\/www.nsgc.org\/Policy-Research-and-Publications\/Position-Statements\/Position-Statements\/Post\/regulation-of-genetic-testing\" target=\"_blank\"  title=\"https:\/\/www.nsgc.org\/Policy-Research-and-Publications\/Position-Statements\/Position-Statements\/Post\/regulation-of-genetic-testing\" aria-label=\"Hyperlink for this policy position\">https:\/\/www.nsgc.org\/Policy-Research-and-Publications\/Position-Statements\/Position-Statements\/Post\/regulation-of-genetic-testing<\/a><\/div>\n                                <\/div>\n                                <div class=\"field organization\">\n                                    <div class=\"label\">Organization<\/div>\n                                    <div class=\"value\" style=\"background-color: #d334c3\" title=\"National Society of Genetic Counselors (NSGC)\">National Society of Genetic Counselors (NSGC)<\/div>\n                                <\/div>\n                                <div class=\"field subject\">\n                                    <div class=\"label\">Subject<\/div>\n                                    <div class=\"value\" title=\"Genetic Testing,Laboratory (Regulation\/oversight)\">\n                                                                                <span class=\"subject_entry\" style=\"background-color: #c192cd\">Genetic Testing<\/span>\n                                                                                <span class=\"subject_entry\" style=\"background-color: #e49a95\">Laboratory (Regulation\/oversight)<\/span>\n                                                                            <\/div>\n                                <\/div>\n                                <div class=\"field date\">\n                                    <div class=\"label\">Date<\/div>\n                                    <div class=\"value\">November 15, 2022<\/div>\n                                <\/div>\n                            <\/div>\n                        <\/div>\n                                <\/div>\n            <\/div>\n        <\/div>\n        <div class=\"footer\">\n            <a class=\"export\" href=\"\/exports\/Genetic+Testing%2CLaboratory+%28Regulation%2Foversight%29\/0\/\" title=\"Export list\"><i class=\"las la-arrow-circle-down\"><\/i> <span>Export<\/span><\/a>\n        <\/div>\n    <\/div>\n    <script>\n        window.addEventListener(\"load\", function(event){\n            jQuery( document ).ready(function($) {\n                \n            });\n        });\n    <\/script>\n    \n\n\n\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; admin_label=&#8221;Jump Links Sidebar&#8221; disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.16&#8243; 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