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The BD SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. "The collaboration with BioGX to deliver a COVID-19 diagnostic in the U.S. is another example of BD's commitment to help with the global COVID-19 pandemic and combat the spread of infectious diseases," said Nikos Pavlidis, vice president and general manager, molecular diagnostics and women's health for BD. Each unit is capable of analyzing hundreds of samples per day. BD is closely monitoring the COVID-19 (coronavirus) situation across the world and guidance from the U.S. Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and health officials in a variety of affected countries to protect the health and safety of BD employees while ensuring continued availability of our … § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … BD, BioGX Announce FDA Emergency Use Authorization Submissions for New COVID-19 Diagnostics for Use in U.S. New Diagnostics Have Potential to Increase Capacity of COVID-19 Testing in U.S. by Thousands of Tests Per Day, Medication and supply management software, Medication and supply management technologies, Browse all medication and supply management products, Identification and susceptibility testing, Browse all microbiology solutions products, Patient monitoring and temperature management, Critical and emergency care patient monitoring, Browse patient monitoring and temperature management, BD Recykleen sharps collectors and accessories, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention. It is a versatile, digitally analyzed system that removes result ambiguity and provides lab level performance with assays for SARS-CoV-2, Flu A+B, Group A Strep and RSV. The Sample-ReadyTM technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing. Two studies were completed to determine clinical performance. "The foundation of BioGX firmly stands on its team's ability to step up and address such unmet needs with speed. The BD MAX System is designed to help address today’s challenges, while preparing your laboratory for tomorrow’s possibilities. https://www.bd.com/fr-fr/offerings/molecular-diagnostics/hais/bd-max About BD "Our BD MAX System is a versatile molecular platform that enables us to rapidly deliver molecular solutions across our laboratory customers and help communities in need during times of high anxiety." The test has been authorized by FDA under an EUA only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection. The company has supplied health care providers globally with millions of products used in of the fight against COVID-19, including swabs for flu and COVID-19 testing, rapid molecular diagnostic tests on the BD MAX™ System, 15-minute point-of-care antigen testing on the BD Veritor™ Plus System, infusion pumps, infusion sets and catheters. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in 100+ countries through its Global Distribution Network. For more information on BD, please visit bd.com. Antigen testing . This kit allows BD MAX™ System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV). The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. About BioGX © 2020 BD. Each unit is capable of analyzing hundreds of samples per day. "These are challenging times for all of us, more so for our laboratory partners who have an urgent need for an easy to use, reliable test to detect the SARS-CoV-2 to determine if patients have contracted COVID-19," said Shazi Iqbal, Ph.D., chief executive officer of BioGX. workers for COVID-19. For more information on BD, please visit bd.com. A nasopharyngeal specimen was collected and analysed for flu, RSV and SARS-CoV-2 on the BD MAX™ System. The solution also offers configured reporting capabilities, which allow customers in the U.S. to generate reports in accordance with the U.S. Coronavirus Aid, Relief, and Economic Security (CARES) Act. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. The test will be run on the BD MAX System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. Learn more about BD Synapsys. The company applies its proprietary platform-agnostic reagent technology to offer products and contract services across a variety of real-time PCR and Next Generation Sequencing platforms. Ferrari Productions (www.ferrariproductions.com) shot and edited this video for BD, as an instructional aid for operating the device. This kit enables BD MAX System users to run a single module that tests for COVID-19 and Influenza (Flu), along with Respiratory Syncytial Virus (“RSV”) at once. The BD Veritor ™ System for Rapid Detection of SARS-CoV-2 is a chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens in nasal swabs from patients with signs and symptoms who are suspected of COVID-19. ZARAGOZA, Spain and FRANKLIN LAKES, N.J., March 10, 2020 / PRNewswire / -- CerTest Biotec, along with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the VIASURE SARS-CoV-2 Real Time PCR Detection Kit adapted for the BD MAX ™ System has been CE marked to the IVD Directive (98/79/CE). All rights reserved. The test will be run on the BD MAX™ System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. It has not been authorized for use to detect any other viruses or pathogens. The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is not authorized for use by consumers or for at-home use. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test.". BioGX developed the assay for the BD MAX™ System in their Sample-Ready™ ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. FRANKLIN LAKES, N.J. and BIRMINGHAM, Ala., March 16, 2020 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and BioGX Inc, a molecular diagnostics company, today announced that the companies have submitted Emergency Use Authorization requests to the U.S. Food and Drug Administration (FDA) for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 (coronavirus) by thousands of tests per day. It has not been authorized for use to detect any other viruses or pathogens. "BD Synapsys™ Informatics unifies instrument-read COVID-19 test results from the BD Veritor™ and BD MAX™ systems," said Rajeev Sehgal, director of Informatics for BD Integrated Diagnostics Solutions. All rights reserved. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC). Discover Vincent's story. BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), develop and commercialize molecular diagnostics reagents across diverse applications. "The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B," said Nelson Fernandes , managing director of CerTest Biotec. BioGX developed the assay for the BD MAX™ System in their Sample-Ready™ ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. The test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs. BioGX SARS-CoV-2 Reagents for BD MAX System: Results in Table 2A: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 RT-PCR Kit : … By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. SOURCE BD (Becton, Dickinson and Company). BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. • The BD SARS-CoV-2 Reagents for BD MAX™ System can be used to test nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or … The test has been authorized by FDA under an EUA only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection. The test helps fill an urgent need across the U.S. for hospitals to access an easy-to-use, rapid diagnostic test to screen patients and health care workers for COVID-19. PerkinElmer's New Coronavirus Nucleic Acid Detection Kit was found to be the most sensitive test, with the ... Dickinson's BioGX SARS CoV-2 test for the BD MAX system… About the BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has been CE marked to the IVD Directive (98/79/EC), but has not been cleared or approved by FDA. This kit enables BD MAX System users to run a single module that tests for COVID-19 and Influenza (Flu), along with Respiratory Syncytial Virus (“RSV”) at once. Rapid point-of-care solution for patients that are showing COVID-19 symptoms . The BD SARS-CoV-2 Reagent Kit for BD MAX™ System has been CE marked to the IVD Directive (98/79/EC), but it has not been cleared or approved by FDA. BD Synapsys™ Informatics solution provides secure connectivity, integrated workflows, and on-demand actionable insights for laboratories and facilities with Clinical Laboratory Improvement Amendments (CLIA) waivers. Each BD MAX™ System can process 24 samples simultaneously. The BD MAX System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in … The system’s two optional analyzing modes allow it to adapt to your workflow, not the other way around. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. Each unit can return results in two to … The BD Veritor™ Plus System is the portable, easy-to-use testing system that delivers reliable results in just minutes. The tests will be run on the BD MAX™ Molecular Diagnostic Platform, which is already in use in nearly every state across the U.S. at hundreds of laboratories, with each unit capable of analyzing hundreds of samples per day. Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … "The solution's new encrypted reporting capabilities reduce the burden associated with manual reporting. The solution also offers configured reporting capabilities, which allow customers in the U.S. to generate reports in accordance with the U.S. Coronavirus Aid, Relief, and Economic Security (CARES) Act. 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