About ViroGene
ViroGene Diagnostic Industries is an Egyptian developer and manufacturer of in vitro diagnostic (IVD) reagents, with a portfolio of more than 450 products across human and veterinary molecular diagnostics. The majority of the menu carries CE marking, and the remaining assays are progressing through conformity assessment. Products are manufactured in two dedicated facilities, both certified to ISO 13485:2016, and supported by an in-house R&D team capable of designing custom and regionally tuned assays on request.
Explore our Human Diagnostics, Veterinary Diagnostics and Life Science — RUO portfolios.
History
ViroGene Diagnostic Industries Products is an Egypt-based firm. The company was founded in 2022 to make custom nucleic acid tests more widely available and enable the widespread usage of molecular diagnostics with the potential to benefit society. ViroGene Diagnostic Industries Products has some of the most capable scientists in the world with extensive experience in the respective field.
Following this tradition, the ViroGene Diagnostic Industries Products team is actively developing and commercializing new molecular diagnostic assays – fast, flexible, reliable, and close to customer needs.
ViroGene Diagnostic Industries produces a growing portfolio of tests for infectious diseases. Genetics, Oncology, Oncogenetics, and Nucleic Acid Extraction, whether Manual or Automated.
Custom development, OEM & services
R&D and custom assay development
- Custom real-time PCR and RT-PCR assay design, including regionally tuned variant panels.
- Multiplex panel development and ARMS / allele-specific genotyping design.
- Assay transfer onto customer-specified instruments and channel configurations.
- Lyophilised and ambient-stable reagent formats on request.
OEM and private label
- Private-label manufacturing of detection and extraction kits under customer branding.
- Bulk master mix, primer / probe mix and magnetic-bead reagent supply.
- Technology transfer and local-fill programmes for regional manufacturing partners.
Regulatory and technical support
- CE-IVDR technical documentation, IFU and labelling packages in English and Arabic.
- Letters of authorisation and Declarations of Conformity for national registration files.
- Verification and validation support during customer on-site implementation.
Veterinary development & support
Custom assay development
- Design and validation of real-time PCR and RT-PCR assays for additional targets, including regional strains and emerging pathogens.
- Multiplex panel development for herd, flock and pond-level screening workflows.
- Strain differentiation, vaccine-versus-field-strain discrimination and subtyping assays.
- Lyophilised and ambient-stable reagent formats for field and low-infrastructure laboratories.
OEM manufacturing and technology transfer
- Private-label manufacturing of veterinary PCR kits under the customer brand.
- Bulk supply of master mixes, primer-probe mixes, extraction reagents and controls.
- Technology transfer packages including protocols, raw-material specifications and training for local production.
Documentation and technical support
- Product inserts, validation reports and lot-specific certificates of analysis.
- Documentation packages supporting national registration of veterinary reagents.
- Verification and validation support during customer on-site implementation.