BioGX

BioGX, Inc. is a clinical molecular diagnostics manufacturer headquartered in Birmingham, Alabama, with additional offices in Dallas, Texas and Amsterdam, The Netherlands. The company designs and manufactures extraction-free, lyophilized molecular diagnostic reagents and assays for RT-PCR testing, delivered as one-tube, Sample-Ready™ formulations. BioGX specializes in producing Laboratory Developed Tests (LDTs) and Open Source Reagents (OSRs) that enable clinical laboratories to rapidly expand their molecular diagnostics portfolios without requiring reagent extraction steps, reducing turnaround time and operational complexity. Primary product lines include Xfree™ direct RT-PCR assays for SARS-CoV-2, influenza A/B, RSV, monkeypox, HSV-1/HSV-2, VZV, syphilis (Treponema pallidum), Group A Streptococcus, and Mycoplasma pneumoniae. The company also offers Sample-Ready™ PCR assays for Candida auris and multi-platform reagents compatible with leading real-time PCR instruments (Bio-Rad CFX series, Applied Biosystems QuantStudio 5, Bio-Rad CFX96/384 Touch, ABI 7500 Fast Dx). BioGX detects a comprehensive range of bacterial targets (including Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and multiple Gram-negative and Gram-positive pathogens), viral targets, fungi (Candida species), and antimicrobial resistance markers (mecA, vanA/B/C, KPC, NDM, OXA-48). The company holds FDA Emergency Use Authorization (EUA) for Xfree™ COVID-19 Direct RT-PCR and CE-IVD marking for its international product portfolio. BioGX manufactures reagents optimized for high-throughput 96- and 384-well plate formats and fully automated systems such as BD MAX™. The company serves clinical laboratories, hospital systems, diagnostic reference laboratories, and public health agencies globally. Founded in 2007, BioGX combines formulation chemistry with regulatory expertise to enable laboratories of all sizes to implement rapid molecular diagnostics.