IVD Raw Material
Enabling High-Performance Molecular Diagnostics
In vitro diagnostics (IVD) are essential for accurate disease detection, health monitoring, and informed clinical decision-making. Whether in pathogen identification, cancer screening, or genetic disorder diagnosis, the sensitivity and reliability of diagnostic assays rely heavily on the quality and consistency of critical raw materials such as oligonucleotides, synthetic genes, and recombinant proteins.
At GenCefe Biotech, we are dedicated to providing high-quality raw materials tailored for the IVD industry. Our manufacturing and quality management systems are certified under ISO 13485 and ISO 9001, ensuring product consistency, full traceability, and compliance with regulatory standards. Our comprehensive portfolio includes qPCR and NGS primer/probe synthesis, gene synthesis, oligo modifications, and protein expression — all delivered under rigorous quality control to support both clinical and research applications.
Application Scenarios in IVD Development
Diagnostic Method | User Needs | GenCefe Solutions |
Real-Time PCR (qPCR) | Sensitive and specific detection of pathogens or mutations with validated primers and fluorescent probes. | - Custom primer and probe synthesis (FAM, HEX, CY5, etc.) |
Next-Generation Sequencing (NGS) | High-throughput screening of gene panels or microbial communities using robust, uniform primers. | - Custom NGS primer/probe synthesis with barcodes/adapters |
Point-of-Care Testing (POCT) | Rapid and accurate isothermal detection for field or bedside diagnostics. | - Probe types like molecular beacons, Scorpion probes, and custom assays |
Immunodiagnostics (ELISA, CLIA, etc.) | Recombinant antigens and control proteins for antibody detection assays. | - Gene synthesis for viral proteins, antigens, and controls |
Digital PCR (dPCR) | Ultra-sensitive quantification of low-abundance targets or rare mutations. | - Highly pure primers and probes with precision labeling |
Synthetic Controls & Standards | Synthetic targets or internal controls for assay development and regulatory compliance. | - Custom gene synthesis for target regions or mutant standards |
GenCefe Core Service Modules | Supporting Your IVD Pipeline
· qPCR Primer & Probe Synthesis: Custom primers and probes with diverse modifications and labels, including BHQ, FAM, HEX, ROX, and LNA—ideal for clinical-grade qPCR kits.
· NGS Primer & Probe Synthesis: Adapter-tagged or barcode-labeled oligos for target enrichment, amplicon sequencing, and library prep—consistent quality across batches.
· Modified & Labeled Oligo Synthesis: Broad spectrum of chemical modifications: Biotin, Digoxigenin, phosphorylation, 5'/3' labels, LNA, spacers, and more.
· PCR Assay Design Support: Experienced primer/probe design service to optimize specificity and efficiency, reducing time-to-validation.
· Gene Synthesis: High-fidelity synthesis of target sequences, synthetic constructs, and recombinant templates for antigens or control materials.
· Recombinant Protein Expression: Scalable expression of diagnostic enzymes and antigens with customizable tags, expression systems, and purification levels.
