Operon S.A. Company Overview
Overview and History
Operon S.A. (OPERON) is a biotechnology company based in Cuarte de Huerva, Zaragoza, Spain. Founded in 1973 as a small research and development laboratory dedicated to immunochemistry, the organization has expanded into an internationally recognized manufacturer of in vitro diagnostic (IVD) solutions. By 1976, the company began exporting its products internationally, and it currently distributes to over 50 countries worldwide.
Operon operates as a specialized manufacturer, developer, and research entity in biotechnology, employing personnel focused heavily on research, development, and innovation (R&D&i). The company designs and produces diagnostic kits, molecular reagents, and raw biological materials under international quality management standards.
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Core Technologies and Capabilities
Operon’s product development and core technologies focus on three main operational pillars:
- Immunochromatography (Rapid Diagnostic Tests)
- Molecular Diagnostics
- Monoclonal Antibody and Recombinant Antigen Production (Raw Materials)
Additionally, Operon offers customized contract manufacturing services (OEM/OBL) for third-party medical and laboratory partners who require industrial scale-up of IVD assays.
Products and Services Portfolio
1. Rapid Tests (Immunochromatography)
Operon manufactures point-of-care rapid lateral flow immunochromatographic assays designed for immediate clinical decision-making without requiring complex laboratory instrumentation.
Gastrointestinal Diagnostics:
- Viral Pathogens: Rotavirus, Norovirus (Genogroups I & II), and combination tests (Rotavirus-Adenovirus, Rotavirus-Adenovirus-Norovirus).
- Bacterial Pathogens: Clostridioides difficile (GDH antigen and Toxins A/B individual and combination kits), Helicobacter pylori (and H. pylori-Transferrin combo), and Campylobacter.
- Parasitic Infections: Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica (available in single and multiparameter combo panels).
- Inflammatory Markers: Calprotectin tests for monitoring intestinal inflammation.
Respiratory Diagnostics:
- Respiratory Syncytial Virus (RSV)
- Adenovirus
- Influenza A + B
- SARS-CoV-2 (COVID-19) single tests and multiplex combinations (Influenza A+B / SARS-CoV-2, RSV / Influenza A+B, RSV / Adenovirus)
- Streptococcus pneumoniae and Legionella pneumophila
- Group A Streptococcus (Streptococcus pyogenes)
Food Intolerances & Health Monitoring:
- Celiac Disease screening tests.
- Milk adulteration diagnostic assays for food analysis.
- Pregnancy tests (hCG detection).
- Prostate Specific Antigen (PSA) screening.
- Hepatitis B detection assays.
Rapid Test Instrumentation:
- Immunochromatographic (IC) Strip Readers for objective, quantitative, or semi-quantitative assay reading and interpretation.
2. Molecular Diagnostics
Operon develops molecular assays to detect pathogens and genetic targets using nucleic acid amplification techniques, including reverse hybridization (strip-based) and real-time Polymerase Chain Reaction (qPCR).
HLA Allele Genotyping:
- HLA-B27 identification (associated with ankylosing spondylitis and related autoimmune disorders).
- HLA-B5701 identification.
Hereditary Diseases and Human Genetics:
- Hereditary Hemochromatosis mutation panels.
- Thrombosis genetic predisposition panels.
- Y Chromosome Microdeletions related to male infertility.
Respiratory Molecular Panels:
- Multiplex detection for Bordetella pertussis, Bordetella parapertussis, and Bordetella holmesii.
- Respiratory Bacterial Panels (Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae).
- Molecular detection of SARS-CoV-2 and multiplex panels combining SARS-CoV-2, Influenza, and RSV.
Food Intolerance Genetics:
- Genetic testing for Celiac Disease predisposition.
- Primary and secondary Lactose Intolerance genetic panels.
Sexually Transmitted Infections (STIs):
- Human Papillomavirus (HPV) genotyping.
- Multiplex STD Panels for high-prevalence urogenital pathogens.
Molecular Instrumentation:
- Opegen Strip Readers for automated interpretation of reverse-blot nucleic acid hybridization membrane strips.
3. Raw Materials for the Immunoassay Industry
Operon develops and produces biological materials used internally and supplied to commercial assay manufacturers, diagnostic developers, and scientific researchers globally.
- Monoclonal Antibodies: High-affinity antibodies raised against specific viral, bacterial, parasitic, and human protein targets.
- Recombinant Antigens: Engineered proteins produced for inclusion in immunoassay solid phases (ELISA, lateral flow, chemiluminescence).
- Custom Antigen/Antibody Production: Large-scale bioprocessing capacity capable of manufacturing up to hundreds of grams per batch with batch-to-batch consistency controls.
4. Contract Manufacturing and OEM Services
Operon acts as an IVD Contract Development and Manufacturing Organization (CDMO) for external entities seeking to industrialize diagnostic prototypes. Services offered include:
- Transfer of R&D diagnostic prototypes to automated manufacturing lines.
- OEM (Original Equipment Manufacturer) and OBL (Own Brand Labeler) manufacturing of lateral flow tests and molecular kits.
- Validation, quality control compliance, regulatory assistance, and packaging under global regulatory standards for IVD products.
Operating Location
- Headquarters Address: Camino del Plano 19, 50410 Cuarte de Huerva, Zaragoza, Spain.
