Flexibility and standardization allow you to … 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. 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 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 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 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 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. "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. 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. 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 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 is capable of analyzing hundreds of samples per day. Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test.". 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. 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. 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. 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. 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. For more information on BD, please visit bd.com. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in 100+ countries through its Global Distribution Network. 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 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. 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. BioGX operates in a cGMP compliant environment certified to International Standard ISO 13485. 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. "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. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. Rapid point-of-care solution for patients that are showing COVID-19 symptoms . 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. "The solution's new encrypted reporting capabilities reduce the burden associated with manual reporting. Each unit can return results in two to … Each BD MAX™ System can process 24 samples simultaneously. Contacts: Mela Sera, APR                                                      BD Public Relations                                                443-824-8012                                                      Mela.Sera@bd.com, Kristen M. Stewart, CFABD Strategy & Investor Relations201-847-5378Kristen.Stewart@bd.com, 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. Ferrari Productions (www.ferrariproductions.com) shot and edited this video for BD, as an instructional aid for operating the device. Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. This empowers customers to focus on what matters most: Caring for their … Please try new keyword. It has not been authorized for use to detect any other viruses or pathogens. 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. 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. "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 BioGX, please visit BioGX.com. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 … In the first study, nasal specimens and either … 0 results found for "[term]". 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. Two studies were completed to determine clinical performance. The test is … BD Statement on COVID-19 (Coronavirus) Updated November 2020. 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. It has not been authorized for use to detect any other viruses or pathogens. 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. 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*. 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 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 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. workers for COVID-19. 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. The BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. 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). 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