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Publications – Urinary Tract, Sexual Health, Wound

Product CategoryProduct CodeAssay Name/Assay TargetsPublication Citation
Urinary Tract Infection, Sexually Transmitted Infection & Wound350-011-A-MAX
400-003-C-MAX
450-039-C-MAX
Mycoplasma-UreaplasmaAyaz ÇM et al. “Investigation of the Frequency of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and Mycoplasma genitalium in Men Living with HIV in Terms of Sociodemographic Characteristics and Behavioral Risk Factors.” Mikrobiyol Bul. 2023 Jul;57(3):378-389.
Kusanovic, Juan Pedro, et al. "Comparison of two identification and susceptibility test kits for Ureaplasma spp and Mycoplasma hominis in amniotic fluid of patients at high risk for intra-amniotic infection." The Journal of Maternal-Fetal & Neonatal Medicine 33.20 (2020): 3409-3417.
Rosales-Castillo, Antonio, et al. "Emerging Presence of Culturable Microorganisms in Clinical Samples of the Genitourinary System: Systematic Review and Experience in Specialized Care of a Regional Hospital." Journal of clinical medicine 11.5 (2022): 1348.
Van Der Pol, Barbara, et al. "P604 Platform-agnostic reagents for detection of mycoplasma genitalium." (2019): A267-A268.
Siles-Guerrero, Víctor, et al. "Recent clinical relevance of mono-genital colonization/infection by Ureaplasma parvum." European Journal of Clinical Microbiology & Infectious Diseases 39 (2020): 1899-1905.
Rosales-Castillo, Antonio, et al. "Presence and Relevance of Emerging Microorganisms in Clinical Genitourinary Samples." Microorganisms 11.4 (2023): 915.
Chromy, David, et al. "High cure rates of Mycoplasma genitalium following empiric treatment with azithromycin alongside frequent detection of macrolide resistance in Austria." Infection (2024): 1-10.
Ruiz Del Pino, M., et al. "Isolation of Haemophilus no ducreyi in samples from the genital tract of men: Its clinical relationship." Revista Internacional de Andrologia 21.4 (2023): 100374-100374
Defossez, A., et al. “Evaluation of a new syndromic panel (STI, Vivalytic BOSCH®) in the diagnosis of STIs.” Medicine and Infectious Diseases Training 3.2 (2024): S97-S98.
Védy S. et al. "Evaluation d'une PCR en temps réel pour la quantification des mycoplasmes uro-génitaux : A propos de la PCR M. hominis, U.urealyticum, U. parvum développée par la société BioGX® pour l'automate BD MAX ® (Société BD)", Poster (2017), Laboratoire Ketterthill, Luxembourg
Van der Pol B. et al. "Platform Agnostic Reagents for Detection of Mycoplasma genitalium", Poster (2019), University of Alabama, United States
Chandrasekaran S. et al. "Evaluation Of A Multiplex Real Time PCR Assay For The Detection Of Mycoplasma and Ureaplasma species At A Large Tertiary Care Facility", Poster (2018), School of Medicine, University of California Los Angeles, Los Angeles, CA, United States
ÇALIŞKAN, Zeynep, et al. Determination of Gene Mutations Associated with Macrolide and Fluoroquinolone Resistance in Patients Infected with Mycoplasma genitalium_ Microbiology Bülteni 58.4 (2024)
Karpuz, Tuncer, et al. "Investigation of Mycoplasma and Ureaplasma Species Using Molecular Method in Male Patients Suffering from Urethritis Symptoms." (2025)
350-070-C-MAX
450-043-C-MAX
Candida aurisContreras, 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
Arenas, Sebastian, et al. "Operational impact of decreased turnaround times for Candida auris screening tests in a tertiary academic medical center." Antimicrobial Stewardship & Healthcare Epidemiology 3.1 (2023): e176.
Arenas, Sebastian P., et al. "Persistent colonization of Candida auris among inpatients rescreened as part of a weekly surveillance program." Infection Control & Hospital Epidemiology (2023): 1-4.
Arena, Fabio, Paola Bernaschi, and Antonella Mencacci. "Clinical impact of fast platforms and laboratory automation for the rapid diagnosis of infectious diseases and detection of antimicrobial resistance determinants." Frontiers in Cellular and Infection Microbiology 13 (2023).
Banik, Sukalyani, et al. "A simple and sensitive test for Candida auris colonization, surveillance, and infection control suitable for near patient use." Journal of Clinical Microbiology (2024): e00525-24.
Wong, River Chun-Wai, et al. "Current Updates on Molecular Diagnostic Assays Used for Detection of Candida auris: A Systematic Review." Diagnostics 15.2 (2025): 140.
Custom manufactured assayCandida aurisEvans D. et al. "Capture It Before It Is Too Late. Design and Validation of a Rapid PCR Laboratory Developed Test (LDT) for Detecting Candida auris in Swabs Collected from Groin and Axilla." Poster (2024) Advent Health, Orlando, Florida, United States

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BioGX Product Catalogs
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  • BioGX Product Catalogs

BioGX Product Catalogs

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BioGX Product Catalog_Rev. 1.6_22APR20251.97 MB DownloadPreview
BioGX Multi-Platform Product Catalog_Rev1.5_22APR20251.37 MB DownloadPreview
BioGX BD MAX Product Catalog_Rev0.4_14APR20251.18 MB DownloadPreview
Robert Martinez, Ph.D, VP, Business Development & Scientific Affairs

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.

 

Hardy Green, Controller

Mr. Green joined BioGX as a Controller in 2020. He has 30+ years of leadership experience in accounting across diverse industries, including healthcare, water utility management, waste management, mineral extraction, and cash handling. At BioGX, Mr. Green is responsible for managing finance and purchasing departments. He has a BS degree in Accounting from The University of Alabama, and he is a Certified Public Accountant (inactive).

Shazi Iqbal, Ph.D, Venture Partner

Dr. Shazi Iqbal is a Co-Founder of BioGX and served as its CEO from 2011 to June 2024. Now, as a Venture Partner, he leads M&A and strategic investment opportunities to enable innovation partnerships. Dr. Iqbal has over 25+ years of experience in building healthcare startups into profitable growth companies. He holds a Ph.D. in Biology (Neuroscience), two M.S. degrees in Biochemistry & Biotechnology, and several patents and publications.

 

Run Files

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Targets

Bacteria Viruses
Acinetobacter baumannii
Bacteroides fragilis
Chlamydia trachomatis
Citrobacter freundii
Citrobacter koseri
Clostridium novyi/Clostridium septicum
Clostridium perfringens
Enterobacter spp.
Enterobacter cloacae complex
Enterococcus faecalis
Enterococcus faecium
Enterococcus spp. (Enterococcus faecalis, Enterococcus faecium)
Escherichia coli
Gardnerella vaginalis
Haemophilus ducreyi
Kingella kingae
Klebsiella aerogenes
Klebsiella oxytoca
Klebsiella pneumoniae
Klebsiella spp. (Klebsiella oxytoca, Klebsiella pneumoniae)
Morganella morganii
Mycoplasma genitalium
Mycoplasma hominis
Neisseria gonorrhoeae
Proteus mirabilis
Proteus spp. (Proteus mirabilis, Proteus vulgaris)
Proteus vulgaris
Providencia stuartii
Pseudomonas aeruginosa
Salmonella spp.
Serratia marcescens
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus epidermidis group (S. hominis ,S. simulans, S.warneri, S. epidermidis, S. haemolyticus)
Staphylococcus haemolyticus
Staphylococcus lugdunensis
Staphylococcus saprophyticus
Streptococcus agalactiae
Streptococcus pyogenes
Treponema pallidum
Ureaplasma parvum
Ureaplasma urealyticum
HSV-1
HSV-2
Fungi
Candida albicans
Candida auris
Candida glabrata
Candida krusei
Candida parapsilosis
Candida spp. (C.albicans, C. auris, C. dubliniensis, C. glabrata, C. krusei, C.lusitaniae, C. parapsilosis, C. tropicalis)
Candida tropicalis
Protozoan
Trichomonas vaginalis
Antimicrobial Resistance
GES
KPC
mcr-1
mecA
mecC
NDM
OXA-48
van B
vanA
vanC1/C2/C3
VIM

SAMPLE-TO-ANSWER IN 3 EASY STEPS!

 

Shahin Iqbal, Ph.D, President and COO

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.

George Blackstone, VP, Research & Development

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.

 

Christopher Hughes, VP, Operations & QRA

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.

 

Please read this

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.

 

EUO Label Instructions
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  • Emergency Use Only (EUO) Instrument Label

Emergency Use Only (EUO) Instrument Label

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QuantStudio™5 - EUO Label Instructions DownloadPreview
EUO Instrument Label DownloadPreview
Bio-Rad CFX384 Touch™ EUO Label Instructions DownloadPreview
Bio-Rad CFX96 Touch™ EUO Label Instructions DownloadPreview
ABI 7500 Fast Dx - EUO Label Instructions DownloadPreview
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Xfree™ COVID-19  Flyer – Single Sample Testing

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Xfree™ COVID-19  Flyer – Pooled Sample Testing

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Fact Sheets

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.

Healthcare Provider Fact Sheet

Patient Fact Sheet

 

 

 

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Xfree™ COVID-19 IFU and Run Reports

Please complete the form below and our Product  Support Team will be in touch with you shortly.

 

Request Form for Xfree™ COVID-19 IFU & Run Reports

Xfree™ COVID-19 Direct RT-PCR Clinical Concordance Study

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Download the required Direct Sample Run Files and associated PDFs

QuantStudio™ 5

QuantStudio™ 5 Direct Sample Run File

QuantStudio™ 5 Direct Sample PDF

CFX96 Touch™

CFX96 Touch™ Direct Sample Run File 1

CFX96 Touch™ Direct Sample Run File 2

CFX96 Touch™ Direct Sample PDF

 

Introduction to Xfree™ Webinar
This webinar includes an insightful overview of BioGX and what we do.  Furthermore, an Introduction to Xfree™, our extraction-free, high-throughput direct RT-PCR test for COVID-19, provides an understanding of the benefits for laboratories all over the world, associated with this groundbreaking product.
Michael Vickery, PhD, EVP, Chief Scientific Officer

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.