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"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. The Emergency Use Authorization authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. 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. Each unit is capable of analyzing hundreds of samples per day. "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. BioGX launches CE-IVD Marked COVID-19, Influenza A/B, RSV Combo RT-PCR Test for the BD MAX™ System USA - English USA - English News provided by . 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. In the first study, nasal specimens and either … This empowers customers to focus on what matters most: Caring for their … "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. … 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. 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 … BioGX operates in a cGMP compliant environment certified to International Standard ISO 13485. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the test 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 Act, 21 U.S.C. 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. It has not been authorized for use to detect any other viruses or pathogens. About the BD MAX™ System for Detection of SARS-CoV-2 Assay 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. 0 results found for "[term]". The BioGX 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 nasopharyngeal and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. The tests would help fill an urgent need across the U.S. for laboratories to access an easy-to-use, rapid diagnostic test to screen patients for COVID-19. 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. 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. 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. "Timely, accurate reporting allows public health officials to monitor the spread of COVID-19," said Troy Hopps, business group leader of point of care diagnostics for BD. "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 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 : … © 2020 BD. It has not been authorized for use to detect any other viruses or pathogens. About BD 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. SOURCE BD (Becton, Dickinson and Company). Each unit is capable of analyzing hundreds of samples per day. The CARES Act requires COVID-19 testing facilities to report testing data to local and federal health authorities daily, including the number of tests performed, results and key patient demographics. 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 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. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. The BD MAX System is designed to help address today’s challenges, while preparing your laboratory for tomorrow’s possibilities. Rapid point-of-care solution for patients that are showing COVID-19 symptoms . Discover Vincent's story. Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test.". 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. BD Synapsys Informatics was among the first life science diagnostics informatics platforms to receive the Underwriters Laboratory Cybersecurity Assurance Program certification, an independent third-party evaluation that uses standardized, testable criteria for assessing software vulnerabilities and weaknesses. A nasopharyngeal specimen was collected and analysed for flu, RSV and SARS-CoV-2 on the BD MAX™ System. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in 100+ countries through its Global Distribution Network. 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. The test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 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. According to the company, the BD Synapsys solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor and BD MAX systems. 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). 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). By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. 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. 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 less than three hours*. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. Each unit is capable of analyzing hundreds of samples per day. Samples are capable of being analyzed start to finish in two to three hours. BD Statement on COVID-19 (Coronavirus) Updated November 2020. Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … The test has been authorized by FDA under an EUA for use by authorized laboratories. 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 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… 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). 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. Please try new keyword. 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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … Each BD MAX™ System can process 24 samples simultaneously. 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. "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 BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Both BD Veritor™ and BD MAX™ systems have been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to perform SARS-CoV-2 diagnostic testing. 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. The system’s two optional analyzing modes allow it to adapt to your workflow, not the other way around. Ferrari Productions (www.ferrariproductions.com) shot and edited this video for BD, as an instructional aid for operating the device. 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. "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. Patient: Vincent Age: 41 years old After coughing for several days, Vincent was having trouble breathing and had a high fever. Two studies were completed to determine clinical performance. The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. 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). 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 … 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. 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. Antigen testing . FRANKLIN LAKES, N.J., Nov. 23, 2020 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced new reporting capabilities for COVID-19 data, enabling scheduled reports to be generated from BD Synapsys™ Informatics (version 3.84). Contacts: Mela Sera, APR                                                      BD Public Relations                                                443-824-8012                                                      [email protected], Kristen M. Stewart, CFABD Strategy & Investor [email protected], View original content to download multimedia:http://www.prnewswire.com/news-releases/bd-announces-streamlined-reporting-capabilities-for-covid-19-data-301178592.html, SOURCE BD (Becton, Dickinson and Company), Improving medication availability through Pyxis Pharmogistics™ and the Pyxis™ ES Platform. 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. Learn more about BD Synapsys. 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. 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. Flexibility and standardization allow you to … https://www.bd.com/fr-fr/offerings/molecular-diagnostics/hais/bd-max "The solution's new encrypted reporting capabilities reduce the burden associated with manual reporting. Unless otherwise noted, BD, the BD Logo and all other trademarks are the property of Becton, Dickinson and Company or its affiliates. • 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 … COVID result: Positive. The BD Synapsys solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor and/or BD MAX systems. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. BD's (BDX) Real Time PCR Detection Kit enables BD MAX System users to run a single module that tests concurrently for COVID-19, flu and RSV. © 2020 BD. 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. BD Synapsys™ Informatics is an optional integrated informatics solution available to customers using the BD Veritor™ Plus System, a portable instrument delivering SARS-CoV-2 antigen test results in approximately 15 minutes, and the BD MAX™ System, a molecular diagnostic platform returning results in two to three hours. All rights reserved. The BD Veritor™ Plus System is the portable, easy-to-use testing system that delivers reliable results in just minutes. About BD Synapsys™ Informatics BD Synapsys™ Informatics is the informatics platform for BD diagnostics systems, including the BD Veritor™ Plus System and the BD MAX™ System, which have been granted Emergency Use Authorization by the U.S. Food and Drug Administration to perform SARS-CoV-2 diagnostic testing. 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. Each unit can return results in two to … "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. Unless otherwise noted, BD, the BD Logo and all other trademarks are the property of Becton, Dickinson and Company or its affiliates. This empowers customers to focus on what matters most: Caring for their patients.". For more information on BD, please visit bd.com. The BD MAX ™ system offers you an efficient path to improved clinical outcomes by combining and automating extraction and thermocycling into a single platform capable of running both FDA-cleared and open system assays. 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. workers for COVID-19. The Sample-ReadyTM technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing. "The foundation of BioGX firmly stands on its team's ability to step up and address such unmet needs with speed. 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. 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. "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." For more information on BD, please visit bd.com. 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. "For COVID-19 testing facilities – including labs, hospitals and nursing homes – the BD Synapsys™ Informatics solution's new reporting capabilities, supported by secure connectivity, simplifies the process of reporting test results to public health authorities.". 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. Used with the BD Veritor™ Plus System and/or the BD Max™ System, the BD Synapsys™ Informatics 3.84 solution allows customers to export all SARS-CoV-2 test results in a single daily report. BD Announces Streamlined Reporting Capabilities for COVID-19 Data, 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, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention, http://www.prnewswire.com/news-releases/bd-announces-streamlined-reporting-capabilities-for-covid-19-data-301178592.html. The test is … About BD The companies submitted the Emergency Use Authorization requests to FDA today. For more information on BioGX, please visit BioGX.com. "The solution's new encrypted reporting capabilities reduce the burden associated with manual reporting. The BD Synapsys™ solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor™ and/or BD MAX™ systems… 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. Additional configured reports can be developed, as needed. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The BD Synapsys™ solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor™ and/or BD MAX™ systems. 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. As needed the authorization is terminated or revoked sooner, reducing the opportunity for human error and increasing speed. 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