For devices authorized for use with dry swab specimens only, mock swabs are prepared by pipetting 50 μL of each diluted virus stock onto a swab. The master mix tubes are color-coded: N1 tubes use orange foil seals and N2 tubes use red foil seals. 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 ). Mr. Blackstone has designed and directed the development of over 100 multiplex real time PCR products in the fields of food safety, water quality, pharma QC, and clinical diagnostics. From February through the middle of May, the FDA issued a total of 59 EUAs for IVDs for the qualitative detection of nucleic acid from SARS-CoV-2 based on validation data using contrived specimens derived from SARS-CoV-2 viral RNA. C April 2020 detection of the control and target sequences (if present) occur in the PCR chamber. BioGX provides partner-specified formulation and manufacturing services for custom molecular reagent components. The volumes in the FDA-proposed dilution protocol may need to be adjusted to follow the device Instructions for Use. BD BioGX SARS-CoV-2 for BD MAX ™ System BioGX SARS-CoV-2 HMP - N1, N2 & RNase P - High-Volume Multiplex BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX ™ Portfolio fo Tests: New Strains. The BioGX Xfree™ COVID-19 Direct RT-PCR is validated for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. In general, FDA's EUAs require developers to evaluate and submit the analytical limit of detection and assess traceability of their product with any FDA-recommended reference material as a condition of the authorization. The BioGX SARS-CoV-2 Reagents for the BD MAX™ System has not been cleared or approved by FDA. Confirmed results of the relative sensitivity of EUA authorized assays provided by developers as of October 30, 2020, are displayed in Tables 2A, 2B, and 2C. Prior to joining BioGX, Dr. Martinez held research positions focusing on cancer cell biology at Albany Medical College, microbial community dynamics at The Georgia Institute of Technology and microbial physiology at The University of Alabama. SARS-CoV-2 HMP – N1, N2 & RNase P Multiplex is a real-time reverse transcriptase, polymerase chain reaction (PCR) assay for multi-platform use on the BD MAX™, Bio-Rad CFX96 Touch™ and Applied Biosystems QuantStudio™ 5 platforms for the qualitative detection of the presence of RNA from nucleocapsid phosphoprotein gene (N gene) of the SARS-CoV-2 coronavirus and the … dba MicroGen DX, Stanford Health Care Clinical Virology Laboratory, Texas Department of State Health Services, Laboratory Services Section, Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay, The Ohio State University Wexner Medical Center, COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit, UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin, UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel, University of Alabama at Birmingham Fungal Reference Lab, University of North Carolina Medical Center, UNC Health SARS-CoV-2 real-time RT-PCR test, University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory, MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay, Wadsworth Center, New York State Department of Public Health, New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel, Yale New Haven Hospital, Clinical Virology Laboratory, Yale School of Public Health, Department of Epidemiology of Microbial Diseases, Results were obtained with the version of the test authorized on 4/08/2020, Results were obtained with the version of the test authorized on 9/23/2020, Results were obtained with the version of the test authorized on 8/28/2020, Results were obtained with the version of the test authorized on 4/01/2020. The BD MAX System is designed to help address today’s challenges, while preparing your laboratory for tomorrow’s possibilities. Commitment to Helping Resolve... Making Molecular Diagnostics Simple and... BD Molecular Diagnostics: Choices to... Providing Rapid Value-Add Results. 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 BioGX SARS-CoV-2 for BD MAX ™ System BioGX SARS-CoV-2 HMP - N1, N2 & RNase P - High-Volume Multiplex BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX ™ BioGX COVID-19 Tests have the Coverage Christopher has a BSE from Auburn University and an MBA from Troy State University. BD BioGX SARS-CoV-2 Reagents for BD MAX™ System BioGX SARS-CoV-2 HMP – N1, N2 & RNase P Multiplex BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX™ BioGX performed exhaustive genomic sequence database (GISAID & NIH) analysis in order to determine if any of the genomic sequences from the potentially more infectious B.1.1.7 lineage or 501Y.V2 variant … The BioGX SARS-CoV-2 HMP allows ease-of-use across a variety of platforms. BD … Prior to entering graduate school, Dr. Vickery worked as an executive in the lowbed trailer industry for almost 10 years, pioneering the sale of American made heavy equipment transport trailers into China (ROC) and Japan during his tenure in the industry, and resupplying the oilfields of Kuwait with specialized trailers after the Gulf War. Sensitivity Mean Estimates of the EUA authorized SARS-CoV-2 molecular diagnostic tests using the FDA SARS CoV-2 Reference Panel, Policy for Coronavirus Disease-2019 Tests, performance assessment of molecular tests. * No patient matrix was used Just Add Water ™ No extraction reagents required 96 and 384-well plate PCR platforms New … As of October 9, 2020, the FDA has contacted developers of 197 authorized assays for shipping information and by October 14, 2020 sent the reference panel to developers of 181 authorized assays which are included in the tables below. The BioGX SARS-CoV-2 Reagents for the BD MAX System has not been cleared or approved by FDA. Mr. Curtis studied Management Information Systems and Marketing at Franklin University. Operating in a cGMP compliant environment, BioGX has a decade of experience in applying its proprietary “platform-agnostic” reagent technology across a variety of real-time PCR and Next Generation Sequencing platforms. Further, on Mar 11, the company along with CerTest Biotec announced the receipt of CE mark for the VIASURE SARS-CoV-2 real time test adapted for the BD MAX System. Table 2A - Swabs in Transport Media Testing is limited to laboratories certified under the Clinical Laboratory Improvement … The 9 laboratories who reported a testing problem with sample COV-02 all used the BioGx SARS-CoV-2 reagent on the BD Max System. Confirmed results from reference data sets received as of October 30, 2020, are shown in Table 2. BioGx users indicated that their results for sample COV-02 were “unresolved” due to an internal control failure and were thus nonreportable. The site is secure. The Reference Panel contains common, independent, and well-characterized reference material that is available to developers of SARS-CoV-2 nucleic acid-based amplification tests (NAATs) for which Emergency Use Authorization (EUA) was requested. He is responsible for providing the global infrastructure, process and technology for BioGX’s global operations. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. Therefore, the FDA authorized IVDs based on available data from contrived samples generated from a range of SARS-CoV-2 material sources (for example, gene specific RNA, synthetic RNA, or whole genome viral RNA) for analytical and clinical performance evaluation. 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. The FDA is reviewing results as they are returned and continues to send the reference panel out to additional developers. Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System: Results in Table 2A: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 … Prior to joining BioGX, Mr. Hughes led efforts for a diverse range of companies with the development and implementation of certified quality management systems ranging from data storage devices with SONY Corporation, security & detention devices with Norment Security Group, textile manufacturing with Twitchell Corporation, combat vehicle manufacturing with General Dynamics, and therapeutic medical devices with Steris Corporation. He has served at BioGX in various senior R&D and quality management roles prior to his current position as Senior Director of Product Development. Dr. Iqbal received a Ph.D. in Biology from University of Texas at San Antonio, holds two master’s degrees in Biochemistry and Biotechnology and has several patents and publications to his name. Biosystems QuantStudio™ 5. However, it has been authorized by the FDA under an EUA. If several specimen types are authorized, nasopharyngeal (NP) swabs were recommended to use. The BD MAX System is designed to help address today’s challenges, while preparing your laboratory for tomorrow’s possibilities. He is the recipient of the President awards and multiple service & innovation awards at Abbott. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2). 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. Acupath COVID-19 Real-Time (RT-PCR) Assay, Alpha Genomix TaqPath SARS-CoV-2 Combo Assay, BioGX SARS-CoV-2 Reagents for BD MAX System. While the FDA SARS-CoV-2 Reference Panel helps determine the comparative performance among authorized tests, the panel is not a replacement for the analytical and clinical validation recommendations the FDA has provided in the EUA templates. Complete test in one tube Fully automated to simplify workflow BD leads in health care safety - including medication safety, health care worker safety and infection prevention - as well as the technologies that enable medical research and clinical laboratories. Status of "Did not provide shipping information" indicates that no shipping information was received by 10/14/2020. Table 2B-Direct Swabs (Dry Swabs) 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 2019-nCoV in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 … However, it has been authorized by the FDA under an EUA. 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. This webinar includes an insightful overview of BioGX and what we do. "These are challenging times for all … Depending on the test, the number of tests performed on different amounts of viral replicates can range from over 40 to over 150. Mr. Mohammed Merchant joined BioGX in 2020 as Senior Director of Digital Product Management & Marketing, responsible for managing all digital applications and assets. • The BioGX SARS-CoV-2 Reagents for BD MAX™ System should be ordered for the detection of COVID-19 in individuals who meet the COVID-19 clinical and/or epidemiological criteria for testing. Launched BioGX BV in Amsterdam. As the pandemic progressed and more patient specimens became available, on May 11, 2020, the FDA recommended in the Policy for Coronavirus Disease-2019 Tests that developers obtain and use patient specimens to validate their tests. Swabs are collected and transported in media as per the Instructions for Use of each EUA. Transport media refers to Viral Transport Media (VTM), Universal Transport Media (UTM), phosphate-buffered saline (PBS), saline, etc. Previously, Dr. Iqbal worked as Director of CSR Program and Corporate Programs, concurrently leading Cepheid’s custom reagents business and GeneXpert commercialization strategy and sales execution for Veterans Affairs, Department of Defense, national hospital networks and Group Purchasing Organizations. 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. Company: Becton, Dickinson & Company (BD) Indication: Qualitative detection of nucleic acid from SARS-CoV-2 … See our extensive menu of high-performance reagents, For US inquiries: INFO@BIOGX.COM | +1.205.250.8055 The FDA SARS-CoV-2 Reference Panel is shared with developers who have interacted with FDA through the review process. BioGx users indicated that their results for sample COV-02 were “unresolved” due to an internal control failure and were thus nonreportable. Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System RT-PCR BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV RT-PCR BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit RT-PCR Bio-Rad Laboratories, Inc Bio-Rad SARS-CoV-2 ddPCR Test RT-PCR BioFire Defense, LLC BioFire COVID-19 Test RT-PCR BioFire … For more information about this product email covid19@biogx.com. Before sharing sensitive information, make sure you're on a federal government site. The test is in addition to the other tests already available on the BD MAX System from collaborations with BioGX and CerTest and is based on the CDC assay design. The .gov means it’s official.Federal government websites often end in .gov or .mil. The 9 laboratories who reported a testing problem with sample COV-02 all used the BioGx SARS-CoV-2 reagent on the BD Max System. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing), Laboratorio Clinico Toledo SARS-CoV-2 Assay, Laboratory Corporation of America (LabCorp), LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, Omnipathology Solutions Medical Corporation, Orig3n 2019 Novel Coronavirus (COVID-19) Test, Pathology/Laboratory Medicine Lab of Baptist Hospital Miami, PerkinElmer New Coronavirus Nucleic Acid Detection Kit, FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR), Primerdesign Ltd COVID-19 genesig Real-Time PCR assay, LetsGetChecked Coronavirus (COVID-19) Test. Mr. However, it has been authorized by the FDA under an EUA. Simple Yet Superior. Coronavirus (COVID-19) and Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) and Medical Devices, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Face Masks, Including Surgical Masks, and Respirators for COVID-19, Medical Device Supply Chain Notifications During the COVID-19 Pandemic, Medical Device Shortages During the COVID-19 Public Health Emergency, Supplies of Medical Devices for COVID-19: Frequently Asked Questions, Medical Device Types to Help Determine Section 506J Notification Obligations, Non-contact Temperature Assessment Devices During the COVID-19 Pandemic, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents, Contacts for Medical Devices During the COVID-19 Pandemic, SARS-CoV-2 Reference Panel Comparative Data, Development of the FDA SARS-CoV-2 Reference Panel, Distribution and Testing of the Reference Panel, Table 1. Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System RT-PCR BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV RT-PCR BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit RT-PCR Bio-Rad Laboratories, Inc Bio-Rad SARS-CoV-2 ddPCR Test RT-PCR BioFire Defense, LLC BioFire COVID … Tests used at Providence included Abbott ID Now COVID-19, BD SARS-CoV-2 Reagents for BD Max System, BioFire COVID-19, BioGX SARS-CoV-2 reagents for BD Max System, CDC 2019-nCoV RT-PCR Diagnostic Panel, Cepheid Xpert Xpress SARS-CoV-2, LabCorp COVID-19 RT-PCR, Panther Fusion SARS-CoV-2, Roche cobas SARS-CoV-2, Quest SARS-CoV-2 rRT-PCR, … No cross-reactivity with MERS-CoV has been observed unless otherwise specified. The studies are performed by diluting the panel material in "negative patient clinical matrix" acquired and prepared by individual developers. 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. BioGX provided tube snaps into a test-specific position on the BD MAX total nucleic acid extraction cartridge enabling Sample-to-Answer molecular testing. BioGX provides partner-specified formulation and manufacturing services for custom molecular reagent components. The BD MAX System, a molecular diagnostic platform, is already in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period. Recognizing the value to healthcare professionals, laboratories, and patients in understanding the relative performance of NAATs for SARS-CoV-2, the FDA obtained live virus in February to develop a reference panel. The FDA SARS-CoV-2 Reference Panel was first provided to all developers of authorized IVD EUAs that used contrived samples to validate their assay and is provided to all developers who request an EUA for SARS-CoV-2 NAATs. While validation using these contrived specimens provided a measure of confidence in test performance at the beginning of the pandemic, it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources. He brings over 20 years of experience in digital technology, e-commerce, and software product management in various industries and has held product leadership roles at Sprint, Travelocity, Capital One, Sabre, and cxLoyalty. Extraction-Free. • The BioGX SARS-CoV-2 Reagents for BD MAX™ System can be used to test nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal … BD is a leading medical technology company that advances human health in every corner of the world by improving medical research, diagnostics and the delivery of care. The BioGX SARS-CoV-2 Reagents for BD MAX™ System is authorized for use on respiratory specimens from people who meet clinical and/or epidemiological criteria for Coronavirus Disease 2019 (COVID-19) testing. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. ** Test performed with nasopharyngeal swab and saliva, but data uninterpretable. 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