{"id":452468,"date":"2021-03-08T08:03:24","date_gmt":"2021-03-08T13:03:24","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=452468"},"modified":"2021-03-08T08:03:24","modified_gmt":"2021-03-08T13:03:24","slug":"talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\/","title":{"rendered":"Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One\u2122 COVID-19 Test"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">MENLO PARK, Calif., March  08, 2021  (GLOBE NEWSWIRE) &#8212; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=_Rx-kuwb7T3q5UAbhGyNTmQClKQy5sP_iJwEYkZL0ZTlocDIh9AXpO_9dM8b8SQK4z4wAHWDBrvk7TlaDizgbU4fJX6uLD1-jUC4FZaAgfw=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>Talis Biomedical Corporation<\/u><\/a>\u00a0(Nasdaq: TLIS),\u00a0a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point-of-care, today announced that it has withdrawn its current application pursuing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Talis One\u2122 COVID-19 test in the CLIA moderate setting, in favor of focusing on its planned EUA application in the CLIA waived setting. In late February, the FDA\u00a0informed the company that it cannot ensure the comparator assay used in the primary study has sufficient sensitivity to support Talis\u2019s EUA application.<\/p>\n<p>Talis intends to initiate its previously planned clinical validation study in a point-of-care environment, with plans to submit an EUA application for the Talis One COVID-19 test in CLIA waived settings early in the second quarter of 2021. The planned clinical validation study was designed with a different comparator assay, which Talis believes will address the FDA\u2019s concerns.<\/p>\n<p>\u201cThe company\u2019s business priority remains focused on serving health care providers and their patients in the point-of-care setting, where we continue to see the greatest need for high quality testing,\u201d said Brian Coe, Chief Executive Officer of Talis. \u201cGiven the recent correspondence from the Agency and its stated prioritization of point-of-care platforms, we feel this course of action offers a faster path to market.\u201d<\/p>\n<p>\n        <strong>About Talis <\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<br \/>Talis is dedicated to transforming diagnostic testing by developing and commercializing innovative products that are designed to enable accurate, low cost and rapid molecular testing for infectious diseases at the point-of-care, beginning with COVID-19. The company is developing Talis One, a compact, sample-to-answer, cloud-enabled, molecular diagnostic platform. Talis is headquartered in Menlo Park, California. For more information, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=UIWUq1E5yPKEyhNlWaes6XucZaVhXugOuDOlSK7RFfmohVmJ75SwtRT7HqlwHb12aIk9lhkANTCRDHIfOy3A6Q==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">talis.bio. <\/a><\/p>\n<p>\n        <strong>Forward Looking Statements<\/strong><br \/>\n        <br \/>Statements contained in this press release regarding matters that are not historical facts are \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as \u201canticipates,\u201d \u201cfocus,\u201d \u201cpursue,\u201d \u201cwill,\u201d \u201cintends,\u201d \u201cpotential\u201d and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to Talis\u2019 regulatory strategy, including its intention to prioritize an EUA application for its Talis One COVID-19 test in CLIA waived settings and its ability to submit an EUA early in the second quarter of 2021; and Talis\u2019 ability to initiate a new clinical validation study and a limit-of-detection study for its Talis One COVID-19 test in CLIA waived settings, and the timing thereof. These forward-looking statements are based upon the Company\u2019s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that the Talis One COVID-19 test that the Company is developing will be granted an EUA by the FDA; risks that the FDA may require additional information or data in connection with the Company\u2019s EUA; risks and uncertainties associated with the costly and time-consuming development and regulatory approval process and the uncertainty of success; and those discussed in the sections titled \u201cRisk Factors\u201d and \u201cManagement\u2019s Discussion and Analysis of Financial Condition and Results of Operations\u201d in our prospectus dated February 11, 2021, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the SEC\u2019s website at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.<\/p>\n<p>\n        <strong>Contact:<\/strong><br \/>\n        <br \/>Media &amp; Investors<br \/>Emily Faucette<br \/>efaucette@talisbio.com<br \/>+1.415.595.9407<\/p>\n<p \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE4NTg3NCM0MDUyNTc3IzIyMDY0NjA=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/24f2eb26-9990-44e5-9074-2d6c2c804b55\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>MENLO PARK, Calif., March 08, 2021 (GLOBE NEWSWIRE) &#8212; Talis Biomedical Corporation\u00a0(Nasdaq: TLIS),\u00a0a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point-of-care, today announced that it has withdrawn its current application pursuing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Talis One\u2122 COVID-19 test in the CLIA moderate setting, in favor of focusing on its planned EUA application in the CLIA waived setting. In late February, the FDA\u00a0informed the company that it cannot ensure the comparator assay used in the primary study has sufficient sensitivity to support Talis\u2019s EUA application. Talis intends to initiate its previously planned clinical validation study in a point-of-care environment, with plans to submit an EUA application &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One\u2122 COVID-19 Test&#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-452468","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>Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One\u2122 COVID-19 Test - 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\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One\u2122 COVID-19 Test - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"MENLO PARK, Calif., March 08, 2021 (GLOBE NEWSWIRE) &#8212; Talis Biomedical Corporation\u00a0(Nasdaq: TLIS),\u00a0a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point-of-care, today announced that it has withdrawn its current application pursuing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Talis One\u2122 COVID-19 test in the CLIA moderate setting, in favor of focusing on its planned EUA application in the CLIA waived setting. In late February, the FDA\u00a0informed the company that it cannot ensure the comparator assay used in the primary study has sufficient sensitivity to support Talis\u2019s EUA application. Talis intends to initiate its previously planned clinical validation study in a point-of-care environment, with plans to submit an EUA application &hellip; Continue reading &quot;Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One\u2122 COVID-19 Test&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-08T13:03:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE4NTg3NCM0MDUyNTc3IzIyMDY0NjA=\" \/>\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\\\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One\u2122 COVID-19 Test\",\"datePublished\":\"2021-03-08T13:03:24+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\\\/\"},\"wordCount\":654,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODE4NTg3NCM0MDUyNTc3IzIyMDY0NjA=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/talis-provides-update-on-regulatory-pathway-for-emergency-use-authorization-eua-of-its-talis-one-covid-19-test\\\/\",\"name\":\"Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One\u2122 COVID-19 Test - 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In late February, the FDA\u00a0informed the company that it cannot ensure the comparator assay used in the primary study has sufficient sensitivity to support Talis\u2019s EUA application. 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