{"id":411289,"date":"2021-01-08T13:46:37","date_gmt":"2021-01-08T18:46:37","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=411289"},"modified":"2021-01-08T13:46:37","modified_gmt":"2021-01-08T18:46:37","slug":"u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/","title":{"rendered":"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)"},"content":{"rendered":"

<\/p>\n

U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)<\/b><\/p>\n

– Early and Cost-Effective Identification of Samples Potentially Containing the B.1.1.7 or Other Variants May Help Reduce Further Spread of Infection –<\/i><\/p>\n

STONY BROOK, N.Y.–(BUSINESS WIRE<\/a>)–
\nApplied DNA Sciences, Inc. (NASDAQ: APDN) (the \u201cCompany\u201d), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that the U.S. Food and Drug Administration (FDA) published a safety communication (the \u201cCommunication\u201d) that identifies the Company\u2019s Linea\u2122 COVID-19 Assay Kit (the \u201cAssay Kit\u201d) as one of only two tests marketed under the FDA\u2019s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19. The identification of certain mutations can help identify samples that should be further characterized via genetic sequencing and can potentially assist with the early detection of new variants in patients, which may reduce further spread of infection. The full text of the Communication is accessible via the URL below.\n<\/p>\n

\nAccording to the Communication, the FDA monitors the potential effects of genetic variation on molecular tests that have received EUA, including the Company\u2019s Assay Kit. The Communication notes that molecular tests designed to detect multiple SARS-CoV-2 genetic targets, such as the Assay Kit, are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target. Based on analysis conducted by the Company and FDA, one of the two S-gene targets (S1 and S2) of the Assay Kit has significantly reduced sensitivity in the presence of certain S-gene mutations, including a mutation found in the B.1.1.7 variant. The Communication notes that the reduced sensitivity, also known as an S-gene dropout, may be indicative of certain SARS-CoV-2 mutations, including the B.1.1.7 variant. Due to the Assay Kit\u2019s multi-target design, the Communication states the Assay Kit\u2019s overall sensitivity should not be impacted.\n<\/p>\n

\n\u201cOur ability to potentially identify certain variants of SARS-CoV-2 is grounded in the multi-target design of our assay that mitigates the impact of a mutation to the S-gene on test sensitivity. We believe our Assay Kit can give public health officials and diagnostic laboratories a fast and cost-efficient tool \u2013 whether through diagnostic or pooled surveillance testing \u2013 with which to potentially identify and track B.1.1.7 spread that is made all the more challenging by the variant\u2019s apparent transmission advantage,\u201d said Dr. James A. Hayward, president and CEO, Applied DNA. \u201cUsing our Assay Kit, we have already identified variants of SARS-CoV-2 via S-gene dropout, sequenced the identified variants with partners and identified common genetic progenitors that are shared by B.1.1.7 and other emerging SARS-CoV-2 variants. Utilizing this knowledge, we have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat.\u201d\n<\/p>\n

\nLink to FDA safety communication: https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory<\/a><\/p>\n

About the Linea\u2122 COVID-19 Assay Kit and Pooled Surveillance Testing<\/span><\/b><\/p>\n

\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

\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

About Applied DNA Sciences <\/b><\/p>\n

\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

\nVisit adnas.com for more information. Follow us on Twitter <\/a>and LinkedIn<\/a>. Join our mailing list<\/a>.\n<\/p>\n

\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

\nApplied DNA is a member of the Russell Microcap\u00ae Index.\n<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

\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 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>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210108005522\/en\/<\/a><\/span><\/p>\n

Investor contact: <\/b>Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, sanjay.hurry@adnas.com<\/a>
Program contact: <\/b>Mike Munzer, Applied DNA Sciences, 631-240-8814, mike.munzer@adnas.com
\n<\/a>
Web:<\/b>www.adnas.com
\n<\/a>
Twitter: <\/b>@APDN\n<\/p>\n

KEYWORDS:<\/b> New York Europe United States United Kingdom North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Medical Supplies Health FDA Medical Devices Genetics Pharmaceutical Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) – Early and Cost-Effective Identification of Samples Potentially Containing the B.1.1.7 or Other Variants May Help Reduce Further Spread of Infection – STONY BROOK, N.Y.–(BUSINESS WIRE)– Applied DNA Sciences, Inc. (NASDAQ: APDN) (the \u201cCompany\u201d), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that the U.S. Food and Drug Administration (FDA) published a safety communication (the \u201cCommunication\u201d) that identifies the Company\u2019s Linea\u2122 COVID-19 Assay Kit (the \u201cAssay Kit\u201d) as one of only two tests marketed under the FDA\u2019s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, … <\/p>\n

Continue reading “U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)”<\/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-411289","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nU.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) - 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\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) – Early and Cost-Effective Identification of Samples Potentially Containing the B.1.1.7 or Other Variants May Help Reduce Further Spread of Infection – STONY BROOK, N.Y.–(BUSINESS WIRE)– Applied DNA Sciences, Inc. (NASDAQ: APDN) (the \u201cCompany\u201d), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that the U.S. Food and Drug Administration (FDA) published a safety communication (the \u201cCommunication\u201d) that identifies the Company\u2019s Linea\u2122 COVID-19 Assay Kit (the \u201cAssay Kit\u201d) as one of only two tests marketed under the FDA\u2019s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, … Continue reading "U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-08T18:46:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&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\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)\",\"datePublished\":\"2021-01-08T18:46:37+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/\"},\"wordCount\":1301,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/\",\"name\":\"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) - Market Newsdesk\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en\",\"datePublished\":\"2021-01-08T18:46:37+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/#primaryimage\",\"url\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en\",\"contentUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#website\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/\",\"name\":\"Market Newsdesk\",\"description\":\"Latest Business News in Real Time\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\",\"name\":\"Newsdesk\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"caption\":\"Newsdesk\"},\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/author\\\/newsdesk\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) - 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\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/","og_locale":"en_US","og_type":"article","og_title":"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) - Market Newsdesk","og_description":"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) – Early and Cost-Effective Identification of Samples Potentially Containing the B.1.1.7 or Other Variants May Help Reduce Further Spread of Infection – STONY BROOK, N.Y.–(BUSINESS WIRE)– Applied DNA Sciences, Inc. (NASDAQ: APDN) (the \u201cCompany\u201d), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that the U.S. Food and Drug Administration (FDA) published a safety communication (the \u201cCommunication\u201d) that identifies the Company\u2019s Linea\u2122 COVID-19 Assay Kit (the \u201cAssay Kit\u201d) as one of only two tests marketed under the FDA\u2019s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, … Continue reading \"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/","og_site_name":"Market Newsdesk","article_published_time":"2021-01-08T18:46:37+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)","datePublished":"2021-01-08T18:46:37+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/"},"wordCount":1301,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/","name":"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7) - Market Newsdesk","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/#primaryimage"},"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en","datePublished":"2021-01-08T18:46:37+00:00","author":{"@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"breadcrumb":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/#primaryimage","url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en","contentUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210108005522r1&sid=flmnd&distro=nx&lang=en"},{"@type":"BreadcrumbList","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-fda-lists-applied-dnas-linea-covid-19-assay-kit-as-1-of-only-2-eua-authorized-tests-able-to-detect-s-gene-mutation-found-in-sars-cov-2-u-k-variant-b-1-1-7\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.marketnewsdesk.com\/"},{"@type":"ListItem","position":2,"name":"U.S. FDA Lists Applied DNA\u2019s Linea\u2122 COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)"}]},{"@type":"WebSite","@id":"https:\/\/www.marketnewsdesk.com\/#website","url":"https:\/\/www.marketnewsdesk.com\/","name":"Market Newsdesk","description":"Latest Business News in Real Time","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.marketnewsdesk.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979","name":"Newsdesk","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","caption":"Newsdesk"},"url":"https:\/\/www.marketnewsdesk.com\/index.php\/author\/newsdesk\/"}]}},"_links":{"self":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts\/411289","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/comments?post=411289"}],"version-history":[{"count":0,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts\/411289\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/media?parent=411289"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/categories?post=411289"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/tags?post=411289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}