{"id":446518,"date":"2021-03-01T01:18:08","date_gmt":"2021-03-01T06:18:08","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=446518"},"modified":"2021-03-01T01:18:08","modified_gmt":"2021-03-01T06:18:08","slug":"eurofins-announces-the-launch-of-an-at-home-covid-19-pcr-test-kit-available-direct-to-consumers-without-prescription","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/eurofins-announces-the-launch-of-an-at-home-covid-19-pcr-test-kit-available-direct-to-consumers-without-prescription\/","title":{"rendered":"Eurofins Announces the launch of an At-Home COVID-19 PCR Test kit available direct to consumers, without prescription"},"content":{"rendered":"

<\/p>\n

Eurofins Announces the launch of an At-Home COVID-19 PCR Test kit available direct to consumers, without prescription<\/b><\/p>\n

LUXEMBOURG–(BUSINESS WIRE<\/a>)–
\nEurofins\u2019s Clinical Enterprise, Inc. announces that it has received US Food and Drug Administration Emergency Use Authorization (EUA) for a direct-to-consumer (DTC) version of its EmpowerDX COVID-19 Home Collection Kit.\n<\/p>\n

\nThe Eurofins at-home COVID-19 nasal PCR kit is among the first over-the-counter at-home test kits for SARS-CoV-2 to receive EUA. With this authorization, Eurofins is able to sell the test kit directly to consumers without prescription.\n<\/p>\n

\nThe kit is currently available through Eurofins\u2019 subsidiary, empowerDX. The at-home test kits can be easily ordered online for $99 at empowerdxlab.com<\/a>, and are also available in pharmacies across the U.S.\n<\/p>\n

\nThe at-home COVID-19 test kit includes step-by-step instructions, a shallow nasal swab, test tube and a pre-paid FedEx package for the easy return of samples. Customers will receive their results to a secure patient portal within 48 hours.\n<\/p>\n

\nThis test was developed by Eurofins Viracor<\/a>, a leading infectious disease testing laboratory, and is based on its FDA EUA authorized SARS-CoV-2 RT-PCR assay. That assay is ranked one of the most sensitive of the 117 tests evaluated by the FDA SARS-CoV-2 Reference Panel1<\/sup>.\n<\/p>\n

\nEurofins\u2019 CEO, Gilles Martin commented: “This product has the potential to significantly increase population testing rates and help build confidence to accelerate the return of everyday life. We are also working very closely with European authorities for the approval of similar direct-to-consumer products.”\n<\/p>\n

\nThis home-collection kit has not been FDA cleared or approved; rather it has been authorized by FDA under an EUA only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens, and only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices 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

For more information, please visit <\/b>empowerdxlab.com<\/a>,eurofins.com<\/a>.\n<\/p>\n

About Eurofins \u2013 the global leader in bio-analysis<\/b><\/p>\n

\nEurofins is Testing for Life. With over 50,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins\u2019 companies offer a portfolio of over 200,000 analytical methods.\n<\/p>\n

\nEurofins Shares are listed on Euronext Paris Stock Exchange.\n<\/p>\n

\n________________________
\n
1<\/sup>https:\/\/www.fda.gov\/medical-devices\/coronavirus-covid-19-and-medical-devices\/sars-cov-2-reference-panel-comparative-data#results<\/a><\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210228005038\/en\/<\/a><\/span><\/p>\n

\nAnnemarie Watson
\n
ir@eurofins.com<\/a><\/p>\n

KEYWORDS:<\/b> North America France United States Europe Luxembourg<\/p>\n

INDUSTRY KEYWORDS:<\/b> Research Medical Supplies Infectious Diseases FDA Clinical Trials Other Health Biotechnology Pharmaceutical Health Science<\/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":"

Eurofins Announces the launch of an At-Home COVID-19 PCR Test kit available direct to consumers, without prescription LUXEMBOURG–(BUSINESS WIRE)– Eurofins\u2019s Clinical Enterprise, Inc. announces that it has received US Food and Drug Administration Emergency Use Authorization (EUA) for a direct-to-consumer (DTC) version of its EmpowerDX COVID-19 Home Collection Kit. The Eurofins at-home COVID-19 nasal PCR kit is among the first over-the-counter at-home test kits for SARS-CoV-2 to receive EUA. With this authorization, Eurofins is able to sell the test kit directly to consumers without prescription. The kit is currently available through Eurofins\u2019 subsidiary, empowerDX. The at-home test kits can be easily ordered online for $99 at empowerdxlab.com, and are also available in pharmacies across the U.S. The at-home COVID-19 test … <\/p>\n

Continue reading “Eurofins Announces the launch of an At-Home COVID-19 PCR Test kit available direct to consumers, without prescription”<\/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-446518","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nEurofins Announces the launch of an At-Home COVID-19 PCR Test kit available direct to consumers, without prescription - 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\/eurofins-announces-the-launch-of-an-at-home-covid-19-pcr-test-kit-available-direct-to-consumers-without-prescription\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eurofins Announces the launch of an At-Home COVID-19 PCR Test kit available direct to consumers, without prescription - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Eurofins Announces the launch of an At-Home COVID-19 PCR Test kit available direct to consumers, without prescription LUXEMBOURG–(BUSINESS WIRE)– Eurofins\u2019s Clinical Enterprise, Inc. announces that it has received US Food and Drug Administration Emergency Use Authorization (EUA) for a direct-to-consumer (DTC) version of its EmpowerDX COVID-19 Home Collection Kit. The Eurofins at-home COVID-19 nasal PCR kit is among the first over-the-counter at-home test kits for SARS-CoV-2 to receive EUA. With this authorization, Eurofins is able to sell the test kit directly to consumers without prescription. The kit is currently available through Eurofins\u2019 subsidiary, empowerDX. 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