{"id":407275,"date":"2021-01-04T07:03:34","date_gmt":"2021-01-04T12:03:34","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=407275"},"modified":"2021-01-04T07:03:34","modified_gmt":"2021-01-04T12:03:34","slug":"enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/","title":{"rendered":"ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">\n        <em>&#8211; Use of pooled sampling with Enzo\u2019s molecular diagnostic technology can help rapidly expand the number of people tested for COVID-19 &#8211;<\/em>\n      <\/p>\n<p align=\"justify\">NEW YORK, NY, Jan.  04, 2021  (GLOBE NEWSWIRE) &#8212; Enzo Biochem, Inc. (NYSE:ENZ) (\u201cEnzo\u201d or \u201cThe Company\u201d), a leading biosciences and diagnostics company, announced today that it has received an expansion of its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company\u2019s AMPIPROBE<sup>\u00ae<\/sup> SARS-Cov-2 Test System utilizing tests on three different platforms including Enzo\u2019s proprietary GENFLEX\u2122 automated high-throughput platform.<\/p>\n<p align=\"justify\">\u201cThis expansion of the EUA to include pooled samples can rapidly expand testing capacity based on ENZO\u2019s proven, reliable and sensitive PCR-based molecular test for SARS-Cov-2,\u201d said Elazar Rabbani, Ph.D., Enzo CEO. \u201cAccess to testing remains a challenge in many states and the introduction of a new and more easily transmissible variant of COVID-19 is likely to increase demand for testing services in the year ahead despite the introduction of multiple vaccines.\u201d<\/p>\n<p align=\"justify\">Pooling samples involves qualitative detection of nucleic acid from SARS-CoV-2 in up to five individual upper respiratory swab specimens collected in separate vials containing transport media from individuals that healthcare providers consider to be suspected of COVID-19 infection. Samples can include nasal, mid-turbinate, nasopharyngeal, or oropharyngeal swabs. The now authorized \u201cpooled\u201d approach significantly increases the number of individuals who can be tested with available testing resources. <\/p>\n<p align=\"justify\">In its letter of authorization dated December 30, 2020, the FDA stated that the AMPIPROBE<sup>\u00ae<\/sup> SARS-Cov-2 Test System is authorized under EUA and the \u201cproduct described in the Scope of Authorization of this letter (Section II) meets the criteria set forth in Section 564(c) of the (Federal, Food, Drug, and Cosmetic) Act concerning safety and potential effectiveness.\u201d<\/p>\n<p align=\"justify\">\u201cExpansion of our EUA is another reflection of the proven accuracy and safety in Enzo\u2019s AMPIPROBE\u00ae SARS-Cov-2 Test System,\u201d Dr. Rabbani noted. \u201cThis option immediately positions labs to expand capacity and meet expected significantly rising demand for testing services for COVID-19.\u201d\u00a0 <\/p>\n<p>\n        <strong><br \/>\n          <u>About Enzo Biochem<\/u><br \/>\n        <\/strong>\n      <\/p>\n<p align=\"justify\">Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences and intellectual property through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. A global company, Enzo Biochem utilizes cross-functional teams to develop and deploy products, systems and services that meet the ever-changing and rapidly growing needs of health care today and into the future. Underpinning Enzo Biochem\u2019s products and technologies is a broad and deep intellectual property portfolio, with patent coverage across a number of key enabling technologies.<\/p>\n<p align=\"justify\">\n        <strong><br \/>\n          <u>Forward-Looking Statements<\/u><br \/>\n        <\/strong>\n      <\/p>\n<p align=\"justify\">Except for historical information, the matters discussed in this release may be considered &#8220;forward-looking&#8221; statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management, including those related to cash flow, gross margins, revenues, and expenses which are dependent on a number of factors outside of the control of the Company including, inter alia, the markets for the Company\u2019s products and services, costs of goods and services, other expenses, government regulations, litigation, and general business conditions. See Risk Factors in the Company\u2019s Form 10-K for the fiscal year ended July 31, 2020. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this release.<\/p>\n<p align=\"center\">###<\/p>\n<p align=\"left\">\n        <br \/>Contact:<\/p>\n<p>For Enzo Biochem, Inc.<\/p>\n<p>David Bench, CFO<br \/> 212-583-0100<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=jnnVZBZF397MuaDwmjRu8nT51ySyNwgn7oSGppFZAE7lI6HiMC7tG0A4bc_XSjkphstJglSRNQnsWBzBsvzTFA==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>dbench@enzo.com<\/u><\/a><\/p>\n<p>Media: <\/p>\n<p>Marisa Monte\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <br \/>Berry &amp; Company Public Relations<br \/>212-253-8881<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=lKP5aIdyY8ijSQGm2XlLcwDoaTTZ1aOZhf4jzO_zdn1RM9RkVS6JSWYyW9p-kV5okrGE27red3Iltru5459myLM-ejziAMpk8NNCiQcb3Sg=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>mmonte@berrypr.com<\/u><\/a><\/p>\n<p>Investors:<\/p>\n<p>Jeremy Feffer<br \/>LifeSci Advisors, LLC<br \/>212-915-2568<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=qm1jp20DBpWdT7BF2O1ND0uG5FpwE0N9ueUqVzuKXc2YLBvBFlJJWJBZ3d87u7lMPFLxLVWvkP8STGrFtR3hx---Nlr-VsebvKY4xICI92-ohPDLxHG4gnx4LgnLn20p\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>jeremy@lifesciadvisors.com<\/u><\/a><\/p>\n<p>Steve Anreder<br \/>Anreder &amp; Company<br \/>212-532-3232<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7wOplpKr5IHsMW2LeAovBdHv9F7xBhCOpKWEPKid2k4CjsRoIA0sZ7poRn1wDoFSTvbfLZ38TZpgxU-3Ojhrhf_LGE64ndZkUCVrpzQb4LvzkE9wJltj1NEOIfN9VlhJ\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>Steven.anreder@anreder.co<\/u><u>m<\/u><\/a><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExOTc2MyMzOTAyNTQ5IzUwMDA3MTYzNQ==\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/ca3832af-4a38-4be3-ac1a-8af68932560c\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>&#8211; Use of pooled sampling with Enzo\u2019s molecular diagnostic technology can help rapidly expand the number of people tested for COVID-19 &#8211; NEW YORK, NY, Jan. 04, 2021 (GLOBE NEWSWIRE) &#8212; Enzo Biochem, Inc. (NYSE:ENZ) (\u201cEnzo\u201d or \u201cThe Company\u201d), a leading biosciences and diagnostics company, announced today that it has received an expansion of its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company\u2019s AMPIPROBE\u00ae SARS-Cov-2 Test System utilizing tests on three different platforms including Enzo\u2019s proprietary GENFLEX\u2122 automated high-throughput platform. \u201cThis expansion of the EUA to include pooled samples can rapidly expand testing capacity based on ENZO\u2019s proven, reliable and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-407275","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2 - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"&#8211; Use of pooled sampling with Enzo\u2019s molecular diagnostic technology can help rapidly expand the number of people tested for COVID-19 &#8211; NEW YORK, NY, Jan. 04, 2021 (GLOBE NEWSWIRE) &#8212; Enzo Biochem, Inc. (NYSE:ENZ) (\u201cEnzo\u201d or \u201cThe Company\u201d), a leading biosciences and diagnostics company, announced today that it has received an expansion of its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company\u2019s AMPIPROBE\u00ae SARS-Cov-2 Test System utilizing tests on three different platforms including Enzo\u2019s proprietary GENFLEX\u2122 automated high-throughput platform. \u201cThis expansion of the EUA to include pooled samples can rapidly expand testing capacity based on ENZO\u2019s proven, reliable and &hellip; Continue reading &quot;ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-04T12:03:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExOTc2MyMzOTAyNTQ5IzUwMDA3MTYzNQ==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2\",\"datePublished\":\"2021-01-04T12:03:34+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\\\/\"},\"wordCount\":681,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODExOTc2MyMzOTAyNTQ5IzUwMDA3MTYzNQ==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\\\/\",\"name\":\"ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2 - 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(NYSE:ENZ) (\u201cEnzo\u201d or \u201cThe Company\u201d), a leading biosciences and diagnostics company, announced today that it has received an expansion of its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company\u2019s AMPIPROBE\u00ae SARS-Cov-2 Test System utilizing tests on three different platforms including Enzo\u2019s proprietary GENFLEX\u2122 automated high-throughput platform. \u201cThis expansion of the EUA to include pooled samples can rapidly expand testing capacity based on ENZO\u2019s proven, reliable and &hellip; Continue reading \"ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/","og_site_name":"Market Newsdesk","article_published_time":"2021-01-04T12:03:34+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExOTc2MyMzOTAyNTQ5IzUwMDA3MTYzNQ==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2","datePublished":"2021-01-04T12:03:34+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/"},"wordCount":681,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExOTc2MyMzOTAyNTQ5IzUwMDA3MTYzNQ==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/enzo-biochem-receives-fda-emergency-use-authorization-for-testing-pooled-samples-on-three-platforms-including-companys-genflex-proprietary-system-for-detection-of-coronavirus-sars-co\/","name":"ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY\u2019S GENFLEX\u2122 PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2 - 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