{"id":416475,"date":"2021-01-19T07:03:56","date_gmt":"2021-01-19T12:03:56","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=416475"},"modified":"2021-01-19T07:03:56","modified_gmt":"2021-01-19T12:03:56","slug":"applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\/","title":{"rendered":"Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwuline { text-decoration: underline }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\">\nApplied DNA Linea<sup>\u2122<\/sup> COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing\n<\/p>\n<p class=\"bwalignc\"><i>&#8211; Confirms Assay Kits\u2019 Value in Tracking New SARS-CoV-2 Variants in Surveillance and Diagnostic Testing &#8211;<\/i><\/p>\n<p class=\"bwalignc\"><i>&#8211; Vast Majority of PCR and Antigen Testing Unable to Detect Currently Known Variants &#8211;<\/i><\/p>\n<p class=\"bwalignc\"><i>&#8211; Multiple-Targets Assay Design Provides for Positive Results for Infected Individuals, while S-Gene \u201cDropout\u201d Signals the Presence of a Variant \u2013<\/i><\/p>\n<p>STONY BROOK, N.Y.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nApplied DNA Sciences, Inc. (NASDAQ: APDN) (the \u201cCompany\u201d), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Linea\u2122 COVID-19 Assay Kit (the \u201cAssay Kit\u201d) identified COVID-19 positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in the pandemic until now. The variants were identified as part of the Company\u2019s safeCircle<sup>TM<\/sup> pooled surveillance testing service, which is powered by the Company\u2019s Assay Kits. The Assay Kits are also available for diagnostic use in third-party laboratories certified for complex molecular diagnostics.\n<\/p>\n<p>\nBeginning in December 2020, the Assay Kit identified multiple instances of COVID-19 positive individuals whose samples evidenced a specific S-gene mutation known as 69-70 deletion (69-70del). Detection of samples carrying 69-70del with the Assay Kit is accomplished via S-gene dropout observed in one of the two Assay Kit\u2019s SARS-CoV-2 genetic targets. Gene sequencing methods confirmed the variants identified by the Assay Kit. The 69-70del mutation is found in several variants, including B.1.1.7, also known as the U.K. variant, that is characterized by increased transmissibility.\n<\/p>\n<p>\nDr. James Hayward, president and CEO of Applied DNA, stated: \u201cWe believe that a testing strategy that is grounded in its use of our Assay Kit should be considered by any community, company, government or organization that wants to surveil their cohorts for the presence of new variants, detect them early, and take steps to contain them. Our Assay Kit is available immediately for any certified diagnostic lab or surveillance program.\u201d\n<\/p>\n<p>\nAs announced on January 8, 2021, the U.S. Food and Drug Administration announced that the Company\u2019s Assay Kit was one of a select few molecular diagnostics that could potentially identify SARS-CoV-2 variants that contain a specific S-gene (that encodes for Spike protein) mutation known as 69-70del. Due to the Assay Kit\u2019s multi-target design, the overall sensitivity of the Assay Kit is not impacted, and a positive result is still obtained for variant-infected samples.\n<\/p>\n<p>\nThe virus that causes COVID-19, SARS-CoV-2, is prone to mutate over time, especially within patients who remain chronically infected over months, resulting in genetic variations in the population of circulating viral strains. Concern has been building among <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fvolumes%2F70%2Fwr%2Fmm7003e2.htm%3Fs_cid%3Dmm7003e2_w&amp;esheet=52363538&amp;newsitemid=20210119005276&amp;lan=en-US&amp;anchor=scientists&amp;index=1&amp;md5=547539fe6a9e3a2ac2d7bdf317f81ed8\">scientists<\/a> that new variants will dominate in American infections by Spring, a challenge exacerbated by the inability of the vast majority of PCR and antigen tests to specifically detect these variants. The recent detection of multiple variants via S-gene dropout with the Assay Kit highlights the importance of utilizing a molecular diagnostic assay that can easily and cost-effectively identify potential variants. The Company believes that the identification of variants, especially the more transmissible U.K. (B.1.1.7) and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.sciencemag.org%2Fnews%2F2021%2F01%2Fnew-coronavirus-variants-could-cause-more-reinfections-require-updated-vaccines&amp;esheet=52363538&amp;newsitemid=20210119005276&amp;lan=en-US&amp;anchor=new+variants&amp;index=2&amp;md5=4528093c81f2838b85601f7956686e42\">new variants<\/a> from other phylogenetic paths, is essential to containing the spread of COVID-19.\n<\/p>\n<p><b><span class=\"bwuline\">About the Linea<sup>TM<\/sup> COVID-19 Assay Kit and Pooled Surveillance Testing<\/span><\/b><\/p>\n<p>\nThe Linea\u2122 COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes\/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea\u2122 COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and\/or diagnosis of COVID-19 is terminated or until the EUA\u2019s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA\u2019s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.\n<\/p>\n<p>\nThe Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company\u2019s EUA authorization for the Linea\u2122 COVID-19 Assay Kit.\n<\/p>\n<p>\nTo learn more about the Linea\u2122 COVID-19 Assay Kit: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fadnas.com%2Fdxcovid%2F&amp;esheet=52363538&amp;newsitemid=20210119005276&amp;lan=en-US&amp;anchor=https%3A%2F%2Fadnas.com%2Fdxcovid%2F&amp;index=3&amp;md5=bfc1addb69c3c489df80b376d8b97939\">https:\/\/adnas.com\/dxcovid\/<\/a><\/p>\n<p><b>About Applied DNA Sciences<\/b><\/p>\n<p>\nApplied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.\n<\/p>\n<p>\nVisit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.\n<\/p>\n<p>\nThe Company\u2019s common stock is listed on NASDAQ under ticker symbol \u2018APDN\u2019, and its publicly traded warrants are listed on OTC under ticker symbol \u2018APPDW\u2019.\n<\/p>\n<p>\nApplied DNA is a member of the Russell Microcap\u00ae Index.\n<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nThe statements made by Applied DNA in this press release may be \u201cforward-looking\u201d in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA\u2019s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA\u2019s or its partner\u2019s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and\/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and\/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA\u2019s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020, and other reports we file with the SEC, which are available at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov&amp;esheet=52363538&amp;newsitemid=20210119005276&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=4&amp;md5=e94cffc8cb7f5eba0fcd0b4b5b5f1b4d\">www.sec.gov<\/a>. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210119005276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20210119005276\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210119005276\/en\/<\/a><\/span><\/p>\n<p><b>Investor contact: <\/b>Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, <a rel=\"nofollow\" href=\"mailto:sanjay.hurry@adnas.com\">sanjay.hurry@adnas.com<\/a><b \/><br \/><b>Program contact: <\/b>Mike Munzer, Applied DNA Sciences, 631-240-8814, <a rel=\"nofollow\" href=\"mailto:mike.munzer@adnas.com\">mike.munzer@adnas.com<br \/>\n<\/a><br \/><b>Web:<\/b><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.adnas.com&amp;esheet=52363538&amp;newsitemid=20210119005276&amp;lan=en-US&amp;anchor=www.adnas.com&amp;index=5&amp;md5=b7888b76abe1bff608a5bdf8333c25fd\">www.adnas.com<br \/>\n<\/a><br \/><b>Twitter: <\/b>@APDN\n<\/p>\n<p><b>KEYWORDS:<\/b> United States North America New York<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Medical Supplies Biotechnology Other Health Health Pharmaceutical Research Infectious Diseases Hospitals Genetics Science Clinical Trials<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20210119005276\/en\/593924\/3\/box-logo-businesswire.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing &#8211; Confirms Assay Kits\u2019 Value in Tracking New SARS-CoV-2 Variants in Surveillance and Diagnostic Testing &#8211; &#8211; Vast Majority of PCR and Antigen Testing Unable to Detect Currently Known Variants &#8211; &#8211; Multiple-Targets Assay Design Provides for Positive Results for Infected Individuals, while S-Gene \u201cDropout\u201d Signals the Presence of a Variant \u2013 STONY BROOK, N.Y.&#8211;(BUSINESS WIRE)&#8211; Applied DNA Sciences, Inc. (NASDAQ: APDN) (the \u201cCompany\u201d), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Linea\u2122 COVID-19 Assay Kit (the \u201cAssay Kit\u201d) identified COVID-19 positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing&#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-416475","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing - 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\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing &#8211; Confirms Assay Kits\u2019 Value in Tracking New SARS-CoV-2 Variants in Surveillance and Diagnostic Testing &#8211; &#8211; Vast Majority of PCR and Antigen Testing Unable to Detect Currently Known Variants &#8211; &#8211; Multiple-Targets Assay Design Provides for Positive Results for Infected Individuals, while S-Gene \u201cDropout\u201d Signals the Presence of a Variant \u2013 STONY BROOK, N.Y.&#8211;(BUSINESS WIRE)&#8211; Applied DNA Sciences, Inc. (NASDAQ: APDN) (the \u201cCompany\u201d), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Linea\u2122 COVID-19 Assay Kit (the \u201cAssay Kit\u201d) identified COVID-19 positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in &hellip; Continue reading &quot;Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-19T12:03:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210119005276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\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=\"6 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\\\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing\",\"datePublished\":\"2021-01-19T12:03:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\\\/\"},\"wordCount\":1307,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20210119005276r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\\\/\",\"name\":\"Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/applied-dna-linea-covid-19-assay-kit-demonstrates-effectiveness-with-detection-of-multiple-sars-cov-2-variants-during-recent-surveillance-testing\/","og_locale":"en_US","og_type":"article","og_title":"Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing - Market Newsdesk","og_description":"Applied DNA Linea\u2122 COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing &#8211; Confirms Assay Kits\u2019 Value in Tracking New SARS-CoV-2 Variants in Surveillance and Diagnostic Testing &#8211; &#8211; Vast Majority of PCR and Antigen Testing Unable to Detect Currently Known Variants &#8211; &#8211; Multiple-Targets Assay Design Provides for Positive Results for Infected Individuals, while S-Gene \u201cDropout\u201d Signals the Presence of a Variant \u2013 STONY BROOK, N.Y.&#8211;(BUSINESS WIRE)&#8211; Applied DNA Sciences, Inc. 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