Multi-platform Availability
Can be validated and adapted on mainstream open-system platforms
The BioGX Candida auris is a complete PCR mix provided in a single lyophilized tube format to be validated by laboratories on a variety of real-time PCR instruments including BD MAXTM System, ABI QuantStudioTM 5, ABI 7500 Fast Dx, Bio-Rad CFX96 TouchTM , Bio-Rad CFX384 TouchTM , pixlTM real-time PCR platform.
Can be validated and adapted on mainstream open-system platforms
An affordable solution that allows for fast turnaround time
Easy-to-Use, Sample-to-Result application saves your lab time and money
“The BioGX Candida auris PCR assay provides a rapid and sensitive method to perform surveillance testing for our patient population. The real time results have been used by our Epidemiology team to institute timely isolation precautions to successfully prevent C. auris transmission in our medical center.“
Dr. Margie Morgan, Director, Clinical Microbiology Pathology and Laboratory Medicine at Cedars Sinai Hospital
PIXL™ REAL-TIME PCR PLATFORM
650-Series-PXL
BD MAX™
450-043-C-MAX
Multi-Platform
450-043-LMP
Positive Control available from BioGX
Sample Types (to be validated by the labs)
Turnaround Times
Other
* Mulet Bayona, Juan V., et al. “Validation and implementation of a commercial real‐time PCR assay for direct detection of Candida auris from surveillance samples.” Mycoses 64.6 (2021): 612-615.
BioGX Candida auris Assay
Product Code: 350-070-C-MAX/450-043-C-MAX
Contreras, Deisy A., and Margie A. Morgan. “Surveillance diagnostic algorithm using real-time PCR assay and strain typing method development to assist with the control of C. auris amid COVID-19 pandemic.” Frontiers in Cellular and Infection Microbiology (2022): 1053.
Lockhart, Shawn R., Meghan M. Lyman, and D. Joseph Sexton. “Tools for Detecting a “Superbug”: Updates on Candida auris Testing.” Journal of Clinical Microbiology (2022): e00808-21.
Morgan M., Contreras Deisy A. “Combating Candida auris Outbreak Amidst COVID-19 Pandemic” Poster (2022) Department of Pathology and Laboratory Medicine, Cedars Sinai Medical Center, Los Angeles, United States
Wong C. et al “Assessing the limit of detection of Candida auris screening methods using direct-to-agar, broth-enriched-culture, direct-polymerase chain reaction, and broth-enriched-polymerase chain reaction, Poster (2022), Sinai Hospital, University of Toronto
The sudden emergence of Candida auris has gained global interest due to the high rate of invasive infection in hospitals and long-term care facilities.The risk of misidentifying Candida auris can lead to incorrect treatment, rapid transmission amongst patients and potential death. Molecular diagnostic methods are essential for effective detection.
This webinar covers how Cedars-Sinai Medical Center implemented a sensitive and rapid method for Candida auris surveillance and testing.
Bill Standwill has over 25 years of experience in the diagnostics and medical device industry. He joined BioGX in 2023 as Global Head of Commercial. Mr. Standwill has held executive leadership positions for IVD companies including Sherlock Bio, Exact Sciences, T2Bio, Dianon/LabCorp, and Leica/Danaher. He graduated from Rochester School of Technology and serves on their executive board for Applied Critical Thinking. In his career he has helped build 7 late stage biotech startups to commercial success.
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Dr. Martinez joined BioGX in 2015. Dr. Martinez is responsible for Business Development and Scientific Affairs; 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. Shahin Iqbal is the President and Chief Operating Officer at BioGX. He has over 25 years of experience in clinical 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. 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, 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.
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.
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 VP of Research & 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.
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.
Richard Innenberg joined BioGX in 2022 as consulting CFO. Mr. Innenberg has over 30 years of experience in finance and the medical device industry including 25 years as an investment banker to healthcare and medical device companies. He has extensive experience in M&A and raising capital through the public and private markets. Mr. Innenberg worked in increasing roles of responsibility up through Managing Director with Lehman Brothers, Robertson Stephens, Lazard and Piper Jaffray. He is currently a Managing Director with New Century Capital Partners, where he provides investment banking and consulting services to medical device companies, as well as President of RIM Advisors, a medtech strategy consulting firm. He is a Certified Public Accountant (not current), worked in audit and tax with KPMG Peat Marwick. Mr. Innenberg received an MBA degree from The University of Chicago.
Mr. Scott joined BioGX in 2021 as the Director of Operations. He is responsible for Manufacturing, Production, QC Testing, and Operations for BioGX. With more than 12 years in Oral Solid Dose and Aseptic Manufacturing, he also served 8 years in the United States Army. Mr. Scott studied Business Management at Colorado Technical University and also earned a black belt certification in Six Sigma tools and methodologies through Villanova University.
If you are contacting us because you have received a phone call offering genetic testing services, with the caller requesting personal health information and personal identification numbers (such as Medicare Card numbers), please know that we are NOT responsible for such calls.
We, BioGX, Inc., (registered trademark “BioGX”) with offices in Birmingham, AL, Dallas, TX, and Amsterdam, The Netherlands, are a diagnostic test manufacturer and not a testing laboratory, and we are not in any way affiliated with such callers. We do not know who is making these calls.
UNDER NO CIRCUMSTANCES BIOGX WOULD EVER CONTACT INDIVIDUALS TO OFFER GENETIC TESTING SERVICES OR REQUEST PERSONAL INFORMATION OF ANY KIND.
This 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.
QuantStudio™ 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
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. 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.