{"id":16488,"date":"2020-08-13T23:55:00","date_gmt":"2020-08-14T03:55:00","guid":{"rendered":"https:\/\/framinghamsource.com\/?p=16488"},"modified":"2020-08-14T10:09:34","modified_gmt":"2020-08-14T14:09:34","slug":"hologic-launches-validated-pooling-protocol-for-covid-19-testing","status":"publish","type":"post","link":"https:\/\/framinghamsource.com\/index.php\/2020\/08\/13\/hologic-launches-validated-pooling-protocol-for-covid-19-testing\/","title":{"rendered":"Hologic Launches Validated Pooling Protocol for COVID-19 Testing"},"content":{"rendered":"\n<p><strong>[broadstreet zone=&#8221;53820&#8243;]<\/strong><\/p>\n\n\n\n<p><strong>[broadstreet zone=&#8221;52093&#8243;]<\/strong><\/p>\n\n\n\n<p>MARLBOROUGH &#8211; Hologic, Inc. announced this week validated use of its Aptima\u00ae and Panther Fusion\u00ae molecular diagnostic COVID-19 assays with pooled patient samples and completed an emergency use notification to the U.S. Food and Drug Administration (FDA) to make this workflow available to laboratory customers in the United States. <\/p>\n\n\n\n<p>By allowing samples from multiple individuals to be tested simultaneously, pooling is expected to help laboratories deliver increasing numbers of highly accurate molecular test results more quickly.<\/p>\n\n\n\n<p>Hologic believes it is the first test manufacturer in the country to validate and launch a pooling workflow that ensures highly accurate detection of the SARS-CoV-2 virus. <\/p>\n\n\n\n<p>As described in the protocol, pooling is used most effectively in areas or populations of lower disease prevalence.<\/p>\n\n\n\n<p><strong>[broadstreet zone=&#8221;59945&#8243;][broadstreet zone=&#8221;59946&#8243;]<\/strong><\/p>\n\n\n\n<p>\u201cBy providing a pooling protocol, we are helping our lab customers meet the extraordinary demand for highly accurate molecular test results during this unprecedented time,\u201d said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. \u201cPooling will enable more samples to be tested each day, but at the same time, help test results get back to patients and their caregivers faster. I am very proud of the ingenuity and innovations that our Hologic teams continue to bring to fighting this pandemic.\u201d<\/p>\n\n\n\n<p>Hologic\u2019s pooling protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. In cases of a positive result, all five samples are re-tested individually to determine which patient or patients are infected.<\/p>\n\n\n\n<p>The pooling workflow for the Aptima and Panther Fusion SARS-CoV-2 assays has not yet been reviewed by FDA. <\/p>\n\n\n\n<p><strong>[broadstreet zone=&#8221;59947&#8243;]<\/strong><\/p>\n\n\n\n<p>Hologic\u2019s Aptima and Panther Fusion SARS-CoV-2 assays detect the genetic material of the virus and run on fully automated testing platforms that return initial results in approximately three hours. The Aptima SARS-CoV-2 test runs on Hologic\u2019s Panther\u00ae system, and the Panther Fusion SARS-CoV-2 test runs on the Panther Fusion\u00ae system. More than 1,100 of these automated systems are installed in U.S. clinical laboratories. Each Panther and Panther Fusion system can process more than 1,000 SARS-CoV-2 tests in 24 hours. Hologic is currently producing an average of more than one and a half million COVID-19 tests per week.<\/p>\n\n\n\n<p>This project has been funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, as part of an $8.9 million contract.<\/p>\n\n\n\n<p><strong>[broadstreet zone=&#8221;59948&#8243;]<\/strong><\/p>\n\n\n\n<p>***<\/p>\n\n\n\n<p><strong><em>Above is a press release<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>[broadstreet zone=&#8221;53820&#8243;] [broadstreet zone=&#8221;52093&#8243;] MARLBOROUGH &#8211; Hologic, Inc. announced this week validated use of its Aptima\u00ae and Panther Fusion\u00ae molecular diagnostic COVID-19 assays with pooled patient samples and completed an emergency use notification to the U.S. Food and Drug Administration (FDA) to make this workflow available to laboratory customers in the United States. By allowing [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":5063,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"_wpas_customize_per_network":false},"categories":[9,152,193],"tags":[5626,609,1731,5625,194,1813,788],"class_list":["post-16488","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business","category-health","category-marlborough-source","tag-aptima","tag-coronavirus","tag-hologic","tag-marlborough-company","tag-marlborough-source","tag-u-s-department-of-health-and-human-services-hhs","tag-u-s-food-and-drug-administration-fda"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Hologic Launches Validated Pooling Protocol for COVID-19 Testing - Framingham Source<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/framinghamsource.com\/index.php\/2020\/08\/13\/hologic-launches-validated-pooling-protocol-for-covid-19-testing\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hologic Launches Validated Pooling Protocol for COVID-19 Testing - Framingham Source\" \/>\n<meta property=\"og:description\" content=\"[broadstreet zone=&#8221;53820&#8243;] [broadstreet zone=&#8221;52093&#8243;] MARLBOROUGH &#8211; Hologic, Inc. announced this week validated use of its Aptima\u00ae and Panther Fusion\u00ae molecular diagnostic COVID-19 assays with pooled patient samples and completed an emergency use notification to the U.S. Food and Drug Administration (FDA) to make this workflow available to laboratory customers in the United States. 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