{"id":493078,"date":"2021-05-13T09:00:04","date_gmt":"2021-05-13T13:00:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\/"},"modified":"2021-05-13T09:00:04","modified_gmt":"2021-05-13T13:00:04","slug":"pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\/","title":{"rendered":"Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }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\"><b>Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17<\/b><\/p>\n<p class=\"bwalignc\">\nLabcorp Becomes First Major Commercial Lab to Offer a COVID-19 PCR Test Home Collection Kit for Children 2 Years and Older\n<\/p>\n<p>BURLINGTON, N.C.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nLabcorp (NYSE: LH), a leading global life sciences company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The authorization expands the use of Pixel by Labcorp to children and adolescents 2 years of age and older when purchased by a parent or guardian.\n<\/p>\n<p id=\"news-body-cta\">This press release features multimedia. View the full release here: <a href=\"https:\/\/www.businesswire.com\/news\/home\/20210513005610\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210513005610\/en\/<\/a><\/p>\n<div id=\"bwbodyimg\" style=\"width: 480px;float:left;padding-left:0px;padding-right:20px;padding-top:0px;padding-bottom:0px\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20210513005610\/en\/878363\/4\/FDA_EUA_Pixel_2%2B.jpg\" alt=\"Photo courtesy of Labcorp\" \/><\/p>\n<p style=\"font-size:85%\">Photo courtesy of Labcorp<\/p>\n<\/div>\n<p>\n\u201cExpanding access of our Pixel by Labcorp COVID-19 Test Home Collection Kit to include younger populations fills an important need as people seek to resume life activities safely,\u201d said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. \u201cThis is welcome news as children and parents look forward to summer activities, camps, travel and the upcoming school year.\u201d\n<\/p>\n<p>\nPixel by Labcorp COVID-19 PCR Home Collection Kit uses the same PCR test trusted by doctors and hospitals across the country. Individuals age 14-17 can self-collect with adult supervision, and children between the ages of 2 and 13 will need adult assistance to collect their sample.\n<\/p>\n<p>\nBeginning in late May, parents and guardians can request a kit for children 2 years of age and older directly through <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pixel.labcorp.com&amp;esheet=52429241&amp;newsitemid=20210513005610&amp;lan=en-US&amp;anchor=www.pixel.labcorp.com&amp;index=1&amp;md5=7e96be71d7185d730adad60b1a65f737\">www.pixel.labcorp.com<\/a>. Once the request is received by Labcorp, a kit will be shipped to the individual\u2019s home via FedEx. For adults 18 and over, the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit is also available in over 6,000 pharmacies nationwide.\n<\/p>\n<p>\nLabcorp offers its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for zero upfront costs when clinical guidelines are met. Visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.labcorp.com%2Fcovid19&amp;esheet=52429241&amp;newsitemid=20210513005610&amp;lan=en-US&amp;anchor=Labcorp%26%238217%3Bs+COVID-19+website&amp;index=2&amp;md5=46818dfac19376704269576f406c51bf\">Labcorp\u2019s COVID-19 website<\/a> to learn about the company\u2019s testing and drug development offerings.\n<\/p>\n<p>\nThe Pixel by Labcorp COVID-19 PCR Test Home Collection Kit has not been FDA-cleared or approved, but has been authorized for emergency use by FDA under an EUA, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and\/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.\n<\/p>\n<p><b>About Labcorp<\/b><\/p>\n<p>\nLabcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With more than 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $14.0 billion in FY2020. Learn more about us at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.labcorp.com%2F&amp;esheet=52429241&amp;newsitemid=20210513005610&amp;lan=en-US&amp;anchor=www.Labcorp.com&amp;index=3&amp;md5=4daa0215b8fa9a0f800c403b9de18a8a\">www.Labcorp.com<\/a> or follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Flabcorp%2F&amp;esheet=52429241&amp;newsitemid=20210513005610&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=4&amp;md5=6a0fb3591052f0c50f53d24fecc08457\">LinkedIn<\/a> and Twitter <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FLabCorp&amp;esheet=52429241&amp;newsitemid=20210513005610&amp;lan=en-US&amp;anchor=%40Labcorp&amp;index=5&amp;md5=3f70b2909962309db6f72ef3ead34ffa\">@Labcorp<\/a>.\n<\/p>\n<p><b>Labcorp Cautionary Statement Regarding Forward-Looking Statements<\/b><\/p>\n<p><i>This press release contains forward-looking statements, including but not limited to statements with respect to clinical laboratory testing and the potential benefits of a COVID-19 test home collection kit and our responses to and the expected future impacts of the COVID-19 pandemic and the opportunities for future growth. <\/i><\/p>\n<p><i>Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the Company\u2019s control, including without limitation, whether our response to the COVID-19 pandemic will prove effective, the impact of the COVID-19 pandemic on our business and financial condition, as well as on general economic, business, and market conditions, competitive actions and other unforeseen changes and general uncertainties in the marketplace, changes in government regulations, including healthcare reform, customer purchasing decisions, including changes in payer regulations or policies, other adverse actions of governmental and third-party payers, the Company\u2019s satisfaction of regulatory and other requirements, patient safety issues, changes in testing guidelines or recommendations, federal, state, and local governmental responses to the COVID-19 pandemic, adverse results in material litigation matters, failure to maintain or develop customer relationships, our ability to develop or acquire new products and adapt to technological changes, failure in information technology, systems or data security, and employee relations. These factors, in some cases, have affected and in the future (together with other factors) could affect the Company\u2019s ability to implement the Company\u2019s business strategy and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. <\/i><\/p>\n<p><i>The Company has no obligation to provide any updates to these forward-looking statements even if our expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the Company\u2019s most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the Company\u2019s other filings with the SEC.<\/i><\/p>\n<p class=\"bwalignc\">\n# # #\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210513005610r1&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\/20210513005610\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210513005610\/en\/<\/a><\/span><\/p>\n<p><b>Labcorp Contacts:<br \/>\n<\/b><br \/>Media: Christopher Allman-Bradshaw \u2014 336-436-8263<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:Media@Labcorp.com\">Media@Labcorp.com<\/a><\/p>\n<p>\nInvestors: Chas Cook \u2014 336-436-5076<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:Investor@Labcorp.com\">Investor@Labcorp.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> United States North America North Carolina<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Children Biotechnology FDA Managed Care Health Research Infectious Diseases Family Hospitals Consumer Science<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Photo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20210513005610\/en\/878363\/3\/FDA_EUA_Pixel_2%2B.jpg\" alt=\"Photo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\">Photo courtesy of Labcorp<\/font><\/td>\n<\/tr>\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\/20210513005610\/en\/1077269\/3\/Labcorp_Logo_Horizontal_Color_RGB.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>Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 Labcorp Becomes First Major Commercial Lab to Offer a COVID-19 PCR Test Home Collection Kit for Children 2 Years and Older BURLINGTON, N.C.&#8211;(BUSINESS WIRE)&#8211; Labcorp (NYSE: LH), a leading global life sciences company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The authorization expands the use of Pixel by Labcorp to children and adolescents 2 years of age and older when purchased by a parent or guardian. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20210513005610\/en\/ Photo courtesy of Labcorp &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17&#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-493078","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>Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 - 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\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 Labcorp Becomes First Major Commercial Lab to Offer a COVID-19 PCR Test Home Collection Kit for Children 2 Years and Older BURLINGTON, N.C.&#8211;(BUSINESS WIRE)&#8211; Labcorp (NYSE: LH), a leading global life sciences company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The authorization expands the use of Pixel by Labcorp to children and adolescents 2 years of age and older when purchased by a parent or guardian. This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20210513005610\/en\/ Photo courtesy of Labcorp &hellip; Continue reading &quot;Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-05-13T13:00:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20210513005610\/en\/878363\/4\/FDA_EUA_Pixel_2%2B.jpg\" \/>\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=\"5 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\\\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17\",\"datePublished\":\"2021-05-13T13:00:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\\\/\"},\"wordCount\":957,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20210513005610\\\/en\\\/878363\\\/4\\\/FDA_EUA_Pixel_2%2B.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\\\/\",\"name\":\"Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 - 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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\/pixel-by-labcorp-covid-19-pcr-test-home-collection-kit-receives-fda-emergency-authorization-for-ages-2-17\/","og_locale":"en_US","og_type":"article","og_title":"Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 - Market Newsdesk","og_description":"Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17 Labcorp Becomes First Major Commercial Lab to Offer a COVID-19 PCR Test Home Collection Kit for Children 2 Years and Older BURLINGTON, N.C.&#8211;(BUSINESS WIRE)&#8211; Labcorp (NYSE: LH), a leading global life sciences company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The authorization expands the use of Pixel by Labcorp to children and adolescents 2 years of age and older when purchased by a parent or guardian. This press release features multimedia. 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