View source version on businesswire.com: https://www.businesswire.com/news/home/20201213005051/en/, Plus500. COVID-19 : News. With over 50,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services. Disclaimer | Viracor Eurofins, Inc. (Viracor) a leading infectious disease testing laboratory for more than 35 years, announced the launch of its antibody assays for Coronavirus (COVID … A man reacts as a health care worker collects a swab sample to test for the coronavirus, at a testing site, in New Delhi, India, Oct. 17, 2020. Lee's Summit-based Viracor Eurofins has developed an at-home Covid-19 test kit that now has received emergency-use authorization from the Food and Drug Administration. Useful documents. There was an error processing your request. Eurofins Technologies intends to separately file FDA EUA applications for the new testing modalities. Eurofins' innovative COVID-19 assays include: EUA-authorized At-Home COVID-19 PCR Test Kit, pooled, antibody, wastewater, worn-mask, and saliva tests. All rights reserved. The multiplex PCR test allows for a streamlined workflow in one reaction and provides results in approximately one hour. The GSD NovaPrime® SARS-CoV-2 (COVID-19) has now been successfully validated for pharynx gargling samples. These two kits can also be purchased online by appropriately licensed practitioners at the Eurofins Technologies webshop and are for use only where officially authorized in Europe. The Group's objective is to provide its customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly-qualified staff. To learn more, please visit empowerdxlab.com. Stock quotes by finanzen.net. Those that do have an exception to enter must also present a negative COVID-19 test result, carried out less than 72 hours before departure. Eurofins global offer for testing, inspection and certification of products and devices, aimed to serve the increasing demand caused by the coronavirus epidemic. This home-collection kit has not been FDA cleared or approved; rather it has been authorized by FDA under an EUA only for the self-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 in medical devices during the COVID-19 outbreak under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. The GSD NovaPrime® SARS-CoV-2 (COVID-19) is a highly sensitive Multiplex Real-Time PCR test for the direct qualitative pathogen detection of SARS-CoV-2. Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0014000MR3, Reuters EUFI.PA, Bloomberg ERF FP). You have permission to edit this article. As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients' increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world. Sunny in the afternoon. (CercleFinance.com) - Eurofins Scientific fait part du lancement en Europe de son test PCR de la Covid-19 avec des options d'auto-échantillonnage à domicile, … Eurofins Product Service GmbH - Your partner for the testing and certification of electrical and electronic products! About Eurofins – the global leader in bio-analysis. 1 https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data. 76.4% of retail CFD accounts lose money, https://www.businesswire.com/news/home/20201213005051/en/, Registration on or use of this site constitutes acceptance of our, A majority of investors believe the stock market is in a bubble - and many fear a recession, according to an E*Trade survey », Amazon is removing Parler from its web hosting service, meaning the platform will go offline Sunday if it can't find another host », Eurofins Genomics Launches Cost-Effective SARS-CoV-2 full-length Viral Genome Sequencing Services Essential in the Identification of Viral Mutations, Eurofins Launches COVID-19 PCR Tests With At-Home Self-Sampling Options in Europe and Donates Sequencing Capacity to Identify VUI-2020-12/01 Strain Reported to Spread Faster in the UK, Eurofins Raises Its 2020 Objectives After Strong Momentum in Its Core Business, as Well as in COVID-19 Related Activities in October and November, Eurofins Technologies Launches New and Improved Lateral Flow Device Product Line for Allergen Detection in Foodstuffs and Environmental Samples, Eurofins Launches a Rapid SARS-CoV-2 Antigen Test and a RT-PCR Test in a Self-Sampled, Gargling Format, EAG Laboratories Announces Latest Advancement in Transmission Electron Microscopy, Eurofins BioPharma Product Testing Italy Expands Virucidal Testing Capacity With New Dedicated Laboratory. - a SARS-CoV-2 RT-PCR test that has been successfully validated for pharynx gargling samples, providing a gold standard PCR test in an easy-to-use, self-sampling format especially beneficial in the testing of children. Registration on or use of this site constitutes acceptance of our Terms of Service and Privacy Policy. Eurofins (Paris:ERF) announces that its FDA-authorized At-Home COVID-19 Nasal PCR Test is now being covered by Medicare, Medicaid and commercial insurance providers. 07.12.2020 - Regulatory News: Eurofins (Paris:ERF) announces that its FDA-authorized At-Home COVID-19 Nasal PCR Test is now being covered by Medicare, … The assay simultaneously detects two target sequences in the N gene. Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Product testing – Your Industry is our focus Our fields of expertise: Access the test guide for our French client Test guide french France. The GSD NovaGen SARS-CoV-2 (COVID-19) antigen rapid test provides results from nasopharyngeal samples within 15 minutes. FRAMINGHAM, Mass., Dec. 16, 2020 /PRNewswire/ -- Eurofins announces that its FDA-authorized At-Home COVID-19 Nasal PCR Test is now being offered in all 50 states. Available through the Eurofins at-home health testing company, Clinical Enterprise Inc., through its empowerDX business line, the At-Home test can be ordered online (https://empowerdxlab.com/) and will ship to your home or business. Ontario reported 1,940 new cases of coronavirus on Monday, marking the second highest single-day increase, to … Non Invasive Prenatal Test by Eurofins Biomnis – NIPT Reliable results from a simple blood test. www.nipt-biomnis.com. empowerDX is the online shop for easy at-home health testing. Since the launch of the product in May, more than five million tests have been performed on validated sample types. Brussels Airport will carry out four times more coronavirus tests at its testing centre from Friday, the private laboratory Eurofins announced on Thursday. The Eurofins U.S. clinical diagnostics network has been at the forefront of COVID-19 testing – launching its first RT-PCR assay for SARS-CoV-2 on March 13.  Since then, Eurofins has rolled out several highly sensitive and specific assays to thousands of clients nationwide, including hospitals, physicians' offices, nursing homes, government entities, sports organizations and employers.  At-Home COVID-19 testing adds additional capability, alongside pooled, antibody, wastewater, used-mask, saliva and combined COVID-19, Influenza and RSV tests. Welcome to health clarity with just a few clicks. The At-Home COVID-19 Nasal PCR Test is currently not available for those patients residing in the States of New York, New Jersey, Rhode Island, and Maryland. Armed with an exclusive consortium of CLIA-certified and CDC-regulated clinical laboratories in the US, empowerDX is positioned to lead the market for cutting edge, self-collected diagnostic and non-diagnostic testing. The company is based outside of Boston, in Framingham, MA. Made In NYC | Success! Eurofins Scientific, through its subsidiaries (hereinafter "Eurofins" or "the Group"), believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. Viracor Eurofins is providing COVID-19 testing for transplant programs, large hospital systems and local hospital systems such as Saint Luke's and Truman Medical Centers. COVID cases in India are steadily climbing. 1,940 new COVID-19 cases, 23 more deaths in Ontario. In contrast to nasopharyngeal swabs, gargling is a non-invasive, easy-to-use sampling method that is less uncomfortable for the patient and particularly useful for self-sampling applications and the testing of children. Those measures include a mandatory PCR test on day 1 and 7 after return to Belgium. Its R&D teams located at various sites around the world share their expertise in developing a wide range of innovative methods and applications with a focus on immunoassays and molecular testing. © 2021 Insider Inc. and finanzen.net GmbH (Imprint). The GSD NovaPrime® SARS-CoV-2 (COVID-19) is a highly sensitive Multiplex Real-Time PCR test for the direct qualitative pathogen detection of SARS-CoV-2. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Since March, Eurofins US clinical diagnostic testing capacity has ramped up to over 500,000 samples per week.  Recent turnaround time for results has averaged less than 18 hours from specimen receipt in the lab. Find the answers of our expert biologists to your questions about COVID-19. With diagnostic sensitivity of 92.6% and diagnostic specificity of 98.6%, the test meets WHO performance criteria (sensitivity =80%; specificity =97%) for use in the global fight against COVID-19. 4:58PM Travel corridors update imminent Commerce Policy | empowerDX specializes in FDA-authorized COVID-19 testing, women's health, men's health, sexual health and general wellness testing. In the Eurofins press release of 9 April 2020Eurofins Technologies announces the launch of a range of testing kits for serology-based antibody detection by ELISA of patients who have been exposed to COVID-19. However, under the test and release scheme introduced in December, this can be shortened to five days with a negative Covid test. Get local Breaking News alerts sent directly to your inbox. For more information, please visit www.eurofins.com. Things are at their most acute in Paris — but still, only 32 per cent of intensive care beds are occupied by Covid patients. Error! COVID-19 testing … Updated daily, our test guide provides direct access to information on all of the tests offered at Eurofins Biomnis, including preanalytical information, methodologies, clinical significance, forms to be included, stability…. The Airport is ramping up its capacity from 2,000 to 8,000 tests per day in support of new measures for taken by Belgium’s Consultative Committee. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing. Cloudy in the morning. French diagnostics company Eurofins is launching a new, lower-cost product to detect the presence of SARS-CoV-2 virus responsible for the COVID-19 disease, the company said on Thursday.

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