CE-IVD MARKED
We are very pleased with the reliability and performance of this complex respiratory panel. The simultaneous detection of COVID-19, Flu A, Flu B and RSV during Flu season would help further augment the BD MAX™ testing capacity by over 50,000 tests per week.
Complete test in one tube
Fully automated to simplify workflow
High-sensitivity, high-performance
BioGX COVID-19, Flu A, Flu B, RSV – RT-PCR for BD MAX™ System
The test is offered in BioGX’s trusted, easy to use Sample-Ready™ format where all required reagents for real-time PCR are lyophilized in a single tube. 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 kits can be shipped anywhere in the world with no refrigeration required.
The BioGX multiplex COVID-19, Flu A, Flu B and RSV test is intended for qualitative detection of RNA specific to SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus A/B that may be present in Pharyngeal and Nasopharyngeal swab collections in transport media and saline, obtained from individuals at risk of respiratory viral infections.
The assay is provided in a BioGX proprietary Sample-Ready™ lyophilized format sealed in a BD MAX™ tube. Each tube contains all PCR components such as primers, probes, enzymes, dNTPs, and buffers required for real-time PCR-based testing of one sample.
For more information about this product email covid19@biogx.com.
Product Features
The BD MAX™ System is a fully integrated and automated molecular diagnostic platform already in use at thousands of laboratories worldwide.
Product Documents for BioGX COVID-19, Flu A, Flu B, RSV – RT-PCR for BD MAX™
| Title | Size | Download |
|---|---|---|
| UDP_Report_400060GMAX | 34.98 KB | Download |
| 400060GMAX_v1 | 18.83 KB | Download |
| 400-060-G-MAX COVID-19_Flu_RSV - for BD MAX REV01 | 2.04 MB | Download |
For US inquiries: INFO@BIOGX.COM | +1.205.250.8055
For EU inquiries: EU@BIOGX.COM | +31.20.893.4261
Dr. Shahin Iqbal joined BioGX in 2019. Dr. Iqbal is the Senior Vice President of Global Operations at BioGX and has over 20 years of experience in clinical and molecular diagnostics. Before joining BioGX, Dr. Iqbal led the Abbott Diagnostics Global Service & Support specifically for informatics, core lab automation, immunoassay and clinical chemistry systems at Abbott Diagnostics. He was also responsible for design and development of FISH automation systems at Abbott Molecular. He is the recipient of the President awards and multiple service & innovation awards at Abbott. Dr. Iqbal holds multiple patents on optical sensors for covers slips, automation systems development, RFID applications and robotics for system dispensing. Prior to joining Abbott, Dr. Iqbal was head of operations, quality & regulatory, systems development and manufacturing of IHC systems at BioGenex in California. Dr. Iqbal has an MBA and Ph.D as well as a Masters in Electrical Engineering degree from the University of Texas in San Antonio.
Download the required Direct Sample Run Files and associated PDFsQuantStudio™ 5 Direct Sample Run File
QuantStudio™ 5 Direct Sample PDF
CFX96 Touch™ Direct Sample Run File 1
CFX96 Touch™ Direct Sample Run File 2
CFX96 Touch™ Direct Sample PDF
Download the required Extracted Sample Run Files and associated PDFsQuantStudio™ 5 Extracted Sample Run File 1
QuantStudio™ 5 Extracted Sample PDF
CFX96 Touch™ Extracted Sample Run File 1
CFX96 Touch™ Extracted Sample Run File 2
CFX96 Touch™ Extracted Sample PDF
Dr. Shazi Iqbal joined BioGX in 2011 as CoFounder and Chief Executive Officer of the Company. Dr. Shazi Iqbal has over 20 years of experience building healthcare technologies and businesses in business development, corporate sales, global marketing and product development. 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. Prior to Cepheid, he served as Head of Global Marketing and Business Development for BioGenex, a cancer diagnostics company. Dr. Iqbal has co-founded SYFR, MicroGen Systems, GeneXpress Informatics and CodeMD. He started his career as a Senior Scientist at Systems & Processes Engineering Corporation (SPEC). 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. He lives in the San Francisco Bay Area.
Fact SheetsThis Fact Sheet informs you of the significant known and potential risks and benefits of the use of the BioGX Xfree™ COVID-19 Direct RT-PCR. 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.
Healthcare Provider Fact Sheet
Mr. Curtis joined BioGX in 2016. He is responsible for providing the global infrastructure, process and technology for BioGX’s global operations. With more than 20 years in the technology and operations industry, he has also served in various Operations and IT leadership positions at Battelle Memorial Institute, Nationwide Insurance and Cardinal Health. Mr. Curtis has spent much of his career leading Operation and IT consolidations, Cloud technology identification and implementation, process design, improvement and efficiency initiatives. Mr. Curtis studied Management Information Systems and Marketing at Franklin University.
Mr. Mohammed Merchant joined BioGX in 2020 as Senior Director of Digital Product Management & Marketing, responsible for managing all digital applications and assets. 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. Mr. Merchant has a proven track record of taking complex business needs and transforming them into successful digital and mobile products and solutions. He holds an MBA and MS Innovation and Entrepreneurship degrees from University of Texas in Dallas and received his BS in Management Information Systems from Oklahoma State University.
Dr. Martinez joined BioGX in 2015. Dr. Martinez manages global marketing of BioGX manufacturing services; expanding our portfolio of IVD products; managing the global technical support efforts of all molecular diagnostic products; and manages a team of scientists responsible for product and technology innovation in conjunction with existing corporate partnerships. Dr. Martinez has over 20 years of experience in molecular biology. 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. Dr. Martinez holds a BA in Biology from Boston University and a Ph.D. in Microbiology from The Georgia Institute of Technology.
Dr. Vickery founded BioGX in 2007 and served as President and CEO until 2011. Prior to founding BioGX, Dr. Vickery worked in sales and as a technical consultant at Cepheid. Prior to Cepheid, Dr. Vickery worked at the FDA as a University of Maryland JIFSAN postdoctoral fellow at the University of Maryland, and later served as the Lead for Molecular Methods Development at the U.S. FDA Gulf Coast Seafood Laboratory. He holds multiple patents in biotechnology, has authored or co-authored many publications, and has extensive experience in gene expression analysis, and in the design and development of rapid multiplex molecular tests for microbial and viral detection. Dr. Vickery holds a B.S. degree in Physics and both M.S. and Ph.D. degrees in Biology (molecular biology and molecular genetics focus – both prokaryotic and eukaryotic). 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.
Mr. Hughes joined BioGX in 2015. 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. Christopher has a BSE from Auburn University and an MBA from Troy State University.
Mr. Blackstone joined BioGX in 2007. 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. 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. Mr. Blackstone previously served for eight years at the US Food and Drug Administration and as a Commissioned Research Officer in the US Public Health Service Commissioned Corps where he achieved the rank of Lieutenant Commander. George Blackstone received his Master of Science degree from Louisiana State University.
